The future: Making Medicines in your kitchen?

Source: New York Times

Synthesizing drugs in a cooking kitchen is usually reserved for dangerous drug dealers or characters in the popular crime/drama show 'Breaking Bad.'  Although, in China, last November, the New York Times reported on the shortage of drugs which has driven those desperate for medications to resort to drug synthesis in kitchen's (as shown above) and described below:

Zhang Zhejun used a fat plastic straw to gently tap the pale yellow pharmaceutical powder onto a piece of silver foil that lay on an electronic scale. He made sure the amount was just right before he poured it into a clear capsule.

When you’re making cancer drugs at home, the measurements must be precise.

Mr. Zhang has no medical experience and no background in making drugs professionally. He did this out of desperation. His mother suffered from lung cancer and required expensive drugs that China’s ambitious but troubled health care system couldn’t provide.

He was aware of the risks. The drug he was making hadn’t been approved by regulators in China or the United States. Mr. Zhang had bought the raw ingredients online, but he wasn’t sure from whom, or whether they were even real.

As described in the article cited above, the prices of medications are driven by a crisis in health insurance coverage in China.  Since drugs have been synthesized in the kitchen by many around the world over decades (illegally I might add), one is left to wonder with the advances in technology, how far off are we from synthesizing drugs in a kitchen?  Why would I ask such a question?



As technology increases in the pharmaceutical sector along with advancing nanotechnology, the prospect of making pharmaceutical (drugs) might soon be possible from within your kitchen. What?  Yes, you heard me correctly.  Until a few days ago, I was unaware of the fact of the possibility also.  I was catching up on old blog posts on the National Institutes of Health website.  Specifically, the Director of the National Institutes of Health personal blog site -- which is awesome I might add.



After reading the blog post discussed below, I remembered the article cited above from the New York Times.  I just had to connect the two for a blog post.  And here we are.  According to the Director's blog page for the National Institutes of Health, new research and emerging technology called Integrated Scalable Cyto-Technology (InSCyT) as described below:

Today, vaccines and other protein-based biologic drugs are typically made in large, dedicated manufacturing facilities. But that doesn’t always fit the need, and it could one day change. A team of researchers has engineered a miniaturized biopharmaceutical “factory” that could fit on a dining room table and produce hundreds to thousands of doses of a needed treatment in about three days.

As published recently in the journal Nature Biotechnology, this on-demand manufacturing system is called Integrated Scalable Cyto-Technology (InSCyT). It is fully automated and can be readily reconfigured to produce virtually any approved or experimental vaccine, hormone, replacement enzyme, antibody, or other biopharmaceutical. With further improvements and testing, InSCyT promises to give researchers and health care providers easy access to specialty biologics needed to treat rare diseases, as well as treatments for combating infectious disease outbreaks in remote towns or villages around the globe.

In today’s commercial manufacturing facilities, biologic therapies used to treat cancer, cardiovascular disease, and many other disorders are made in huge vats, in which harmless bacteria, yeast, or mammalian cells churn out large quantities of a single product. But researchers, led by NIH grantee J. Christopher Love, Massachusetts Institute of Technology (MIT), Cambridge, have recognized a growing need to design a new kind of manufacturing system, capable of producing a wide variety of clinical-grade products on an as-needed basis.

Dr. Collins continues on in the blog post to describe the simple 3-step modular process: Production, Purification, and Formulation.  The three module system is interconnected and as described in the introduction could potentially fit onto a kitchen or dining room table.  Currently, the researchers were able to produce (synthesize) Human Growth Hormone (HGH).  Of course, this was due to the extensive knowledge surrounding HGH by the scientific community.



Other synthetic compounds were listed.  Typical process development times are at around 12 weeks to fully develop a process for medication.  The amount of doses possible to synthesize in a given week are an astounding 100.  Yes, with this modular set up, the prospect of synthesizing 100 doses in a single week is supposedly being reported.



Currently, the process is composed of plastic bottles, vials, and instruments linked with plastic tubing.  In the future, researchers hope to make the system more user-friendly for the non-chemist in the house.  Does this research line up with where we are as a society?



Shows like 'Breaking Bad' tells us that synthesis is dangerous but a potentially profitable business if you are willing to take the risk.  On the flip side, if the residents in the United States were confronting the crisis in resourcing their medications like those in China are, where are we left to be?  Add to that, the changing academic landscape which is moving more courses from a traditional lecture based room to an online platform - such as "MOOC" - Massive Open Online Courses.



A cursory search for home ready lab class kits reveal a couple of contenders.  First up is a company called "Hands On Labs."  Shown below is an overview video of the product/platform:

The company has been successfully providing lab experiments to universities and people from 1994.  Of course, that is not to say that 'Hands On Labs" has been shipping chemistry labs to individual houses for instruction since 1994.  Individual shipping has kept pace with the development of the 'Massive Open Online Course' platform.  More and more universities are leaning or being nudged to adopt a version of this curricula as technology improves and education changes.  Visit 'Hands On Labs' website for greater detail.



Next up is a competitor company is 'Carolina Biological Supply Company' with a website filled with kits ready for purchase and soon to be shipped immediately after.  Here is an introductory video shown below:

The company was founded by professors as indicated on their 'Wikipedia' page.  For those interested in looking into greater detail into Carolina Biological Supply Company, access their website by clicking here or their YouTube Channel by clicking here.  The range of experiments and samples offered by these companies really gives a person a sense that the university is rapidly disappearing. Not so...at least for the moment.



There still exists a large array of common experiments which cannot be 'outsourced' to an individual's home for self application.  Hazardous chemicals which work extremely well in certain synthetic routes still need to be professionally handled by trained staff members at the university.  Although, one could argue that the production of such kits is great for one reason alone.  Production of laboratory kits with experiments which illustrate principles taught in first and second year chemistry course will improve science overall.  What do I mean by this?



As the world changes toward more sustainable living conditions, corporations will eventually have to find 'greener' substitutes for harsher (corrosive) chemicals.  Products from companies listed above give us hope that the transition is already being considered.  Any shipped chemistry experiment has the potential to turn a kitchen or workspace inside a house into a disaster zone if improperly handled.  Therefore, the researchers/producers of such kits need to consider every possible misuse of their products by the average user.



In turn, this discovery/consideration forms the impetus for a transition inside of corporations to change toward more environmentally friendly chemicals in their commercial synthesis.  Lab kits like those above are exciting and show the range of possibilities when good scientists put their thinking caps on and think critically toward alternatives which are safe for the consumer and safe for the environment.  Hopefully, no American resident finds himself/herself in a position as described in the New York Times article above -- synthesizing medication in their kitchen out of necessity.  Although, if they do, at least commercial products which have been introduced above will provide a platform for success.



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Parameters: Trade Tariffs Will Affect International Science

Source: University of Pennsylvania 

I have written about trade before on this site.  First, about the potential benefits of 'global free trade' which can be found here.  Second, how the trade tariffs set to hit in recent weeks will affect a whole range of commodities (i.e. products, crops, etc.) which can be found here.  Recently, in the journal 'The Scientist' in an article titled "New US-China Tariffs Could Affect Science" written by Diana Kwon, the potential negative impacts to international science is laid out succinctly.  In the excerpt below, I include the entire article (not too long) to avoid butchering the piece with my own opinion.


Without further ado, here is the article shown below:

On June 15, the Office of the United States Trade Representative released a list of 818 Chinese imports that would be subject to an additional 25 percent tariff starting on July 6. These include products used in scientific research, such as microscopes and parts used in X-rays, magnetic resonance imaging (MRI) scanners, and other imaging devices. While the effect that these tariffs will have on researchers is still unclear, some policy experts worry that President Donald Trump’s policies may impede scientific collaboration and talent flow between the two countries.  

Brian Xu, a toxicologist with The Acta Group, a scientific and regulatory consulting firm, says that because China exports relatively few high-quality scientific instruments, the tariffs on those products are unlikely to have a large effect on researchers in the U.S. However, he notes that Chinese companies produce many synthetic chemicals used by pharmaceutical and biotech companies in the U.S. “If there are tariffs [placed] on those, that’s certainly going to increase costs,” Xu says.  

According to the Trade Representative office (USTR), Trump’s administration is implementing the new tariffs to address the results of an agency investigation, which found China guilty of unfair trade practices. “China’s acts, policies and practices related to technology transfer, intellectual property, and innovation are unreasonable and discriminatory, and burden U.S. commerce,” USTR says in a June 15 statement. 

China immediately retaliated to the US government’s announcement with a list of 545 US exports that it would slap additional taxes on starting next week, along with an additional 114 products—including chemicals and medical equipment—under consideration for additional tariffs.  

Some scientists in the U.S. have expressed concerns to Nature about the potential increase in research equipment costs as a result of the tariffs. But whether the tariffs will have noticeable effects for researchers remains to be seen. 

Scientific organization in the U.S. do not yet see cause for alarm. “At this point, it is unclear what impact this may have on the research ecosystem here in the US, and to date, we have not heard from any ACS [American Chemical Society] members or their respective organizations on this topic,” Glenn Ruskin, the director of ACS External Affairs and Communications, writes in an email to The Scientist. “It is a developing situation and one that we will be watching.”

Likewise, Tom Wang, the chief international officer at the American Association for the Advancement of Science (AAAS), says that “it’s hard to say right now what the direct impact [of the tariffs] will be.” Wang adds that while it will be important to keep an eye on the products used the research community, at this point, the full extent of the tariffs that the U.S. will place on foreign products—and the retaliatory tariffs that may come as a result—is still unknown. 

On the other side of the tariffs, in China, worries are also reserved. Yibing Duan, a science and technology policy researcher at the Chinese Academy of Sciences, tells The Scientist in an email that the potential for the tariffs to increase the cost of research in China is not a big concern, because products bought from the U.S. for scientific purposes “could be imported from the E.U., Japan, and other developed nations.” 

There is, however, fear that the economic dispute between the U.S. and China may intensify. USTR has also released a second set including 284 products that may be subject to additional tariffs. (The agency declined The Scientist’s request for comment.) “Contrary to what the Trump administration has said, trade wars are not easy to win,” says William Hauk, a professor of economics at the University of South Carolina. “They have a tendency to escalate with tit-or-tat measures, and this could start affecting a broader range of products.” 

Spill-over effects  

Duan tells The Scientist that although he does not currently see the new tariffs as a serious concern for research, a trade war between the U.S. and China could create a distrustful environment that may stifle intercountry relationships in the areas of science and technology. 

Wang adds that other moves by the Trump administration, such as the tougher restrictions on visas for Chinese students studying in the U.S., may also reduce scientific cooperation between the two countries. Together, these kinds of policies could have a “chilling effect on collaboration, access to technology, and access to knowledge and talent,” Wang says. 

Hauk notes that, if the US-China trade war escalates, there could be additional restrictions placed on student visas, as well as H1B visas, which allow US companies to hire foreign workers. 

“The argument made by some in this administration is that somehow the U.S. is not the beneficiary of the talent, the knowledge, or the technology from other places, but that the U.S. is giving this away to other countries,” Wang tells The Scientist. “But I think that’s not reflective of how the US scientific system works, in which we do benefit from working with [foreign] people, technologies, and companies.” 

There is more at risk than just products.  Additional risk can be classified as 'services' which I discussed briefly in the previous blog post on trade.  Furthermore, students from China travel abroad to the United States to receive a graduate education mostly to return to China for future work. Although, the United States pharmaceutical industry along with the technology sector do hire and hold onto a large portion of these visiting scholars.  I was in a research lab with international students during graduate school and wrote briefly about the benefit to U.S. science of having diversity in the research lab setting - which can be found here.



Last week, after Independence Day, returning to work, I encountered a colleague who returned back home to visit to China after the end of last semester.  She was frustrated with her travel back to the U.S. on the China side.  Her visa was scrutinized by customs which held up the process for a couple of weeks.  Which translates into a hold on her research here in the United States.  This is normal for visiting scholars in the United States.  But for professors here trying to earn tenure at an academic institution, the delay is critical toward professional advancement.



She remarked that there were much fewer applications to travel abroad - which is a result of harsher immigration laws by the Trump administration (read here). Still, the process was held up on China's side.  The exact reason still remains unknown to this day.



Conclusion...



Overall, trade with China is important.  As I mentioned, more than products are traded and at risk with current negotiations.  The international political scene seems to be interfering with the field of science along with many others.  The potential negative fall out or adverse impact is that the United States could fall behind in output at the research level and technology transfer level.  If China holds potential imports to the United States such as vital chemicals used in research, this in turn directly impacts researchers ability to further advance the U.S. science arena -- which is bad.





More blogs can be found here:


Parameters: Tariffs Affect Trade In Both Directions -- In And Out Of The USA


Parameters: One Parameter Change In The Trade Machine Leads To A 'Re-Adjustment' Of Another


Parameters: Steel And Aluminum Tariffs Are Not Isolated - They Are Tied To Trading Of Other Vital Goods


More blogs are located here

How Much Do New Drugs Cost To Bring To The Pharmacy Counter?

One of the many issues that need to be addressed by politicians is the rising cost of prescription drugs.  Recent examples include the astronomical increase the drug 'Daraprim' by the crooked ex-CEO Martin Skreli of 5600%.  As If the public did not react appropriately, the next example was of the 'EpiPen' of 400% increase which led to a congressional hearing with the CEO Heather Bresch testifying as to the needed increase.  These two examples are outliers, but which still beg the two questions below:



Why do these drugs cost so much to make?  



How long does the average drug take to get to market?



These two questions will be answered with an example or two below.

Drug Design Length And Cost?

In a post that I wrote a few weeks back, I included a video of the process by which a drug goes through to get funded and produced to arrive at your pharmacy.  The process followed the listed steps below:


1) Basic research is conducted by university research laboratories around the nation and funded by the National Institutes of Health.


2) The results from research (are pre-clinical) submitted to the 'Food and Drug Administration' (FDA) for approval to proceed with a 3 phase clinical trial in humans.


3) Pharmaceutical companies proceed to conduct 3 phase clinical trial.


4) If 3 phase clinical trials are successful, then all data (pre-clinical, 3 phase clinical, etc.) is sent back to the Food and Drug Administration for approval to produce and market.


5) The FDA will continue to monitor the drug's progress throughout the lifetime in the marketplace to ensure safety.



In order to grasp the steps in full, a more detailed explanation of the above steps is in order.  At least a clarification of each step will greatly reduce the confusion.   The steps above are a combination of the pharmaceutical industry, academia (universities), and the government -- working on different parts but combined in the big picture.



Steps 1 & 2:



To start with, research is conducted at universities across the United States that is tax-payer funded through government science funding agencies like the National Institutes of Health (NIH) and the National Science Foundation (NSF).  These are the two largest funding sources through which scientific funding is provided.   Other sources include private funding through foundations like the 'Gates foundation,' along with others.



Research that is conducted with this money is typically aimed at preventing or treating disease -- that is the overarching picture or message.  The process seems simple, yet can take up to 20 years and cost nearly $1 billion dollars.  That is quite an investment.  The process begins with fundamental research about diseases at universities.



This process helps uncover the mechanism by which a disease or treatment works.  Examples might include research looking into the mechanism of the spread of the Zika virus.  Research aims to identify the gene or proteins responsible for the pathway through which the disease proceeds.  These are biological targets which can them be investigated to find out how scientists can produce drugs that bind to the targets.  By binding to the target of interest, the elimination of a disease might occur, or the repair of a mutated gene could occur.



The process of finding drugs (or molecules) that bind or 'hit' the biological target might take years.  Hundreds of tests through 'assays' or binding tests which test hundreds of different drugs that show promise of hitting the target.  Extensive testing is conducted and the outcome is a class of candidate drugs that will hit (or bind) the biological target involved in the disease pathway.



An interesting side note is that if there are drugs that hit multiple targets (not specific) then, that drug might have the potential to possess a large amount of 'side effects' -- which are undesirable.  Therefore, testing to ensure that each candidate only hits the desired target in the disease pathway is critical at this stage.  Especially, before the drug is tested on humans.  This part of the drug development process is referred to as "pre-clinical testing."



With the Pre-clinical data gathered at the university level, the data is submitted to the Food and Drug Administration for review.  If the FDA approves of the data enough to advance the candidates toward a "3 phase clinical trial," then a pharmaceutical company will usually take over the testing process from here.



Steps 3 & 4:



The 3 phase clinical trial testing on humans is very expensive and usually out of the limits of university budgets.  Therefore, at this point, a pharmaceutical company will proceed to test the candidates in human trials.  The process starts with phase 1 trial.



Phase 1:



During the phase 1 clinical testing trials, between 20-80 healthy adults are tested with the drug to evaluate the safety of the drug.  Additionally, the drug is tested for a safe dosage and any side effects during this phase.



Phase 2:



Phase 2 testing involves giving the drug to around 100-300 people to test the drug further.  During this phase, a certain portion of the group being tested will have the disease being sought after to treat.  This is to get a better idea as to the efficacy of the drug and knowledge about how the drug is working in either a healthy patient or a patient with the desired disease to be treated.



Phase 3:



The final phase is phase 3 -- which aims to verify the drugs effectiveness.  Approximately 1000-3000 patients with the disease sought to be treated are tested.  During this trial, the pharmaceutical companies will also compare testing other known treatments (drugs, comparing different brands, etc.) and no drugs (placebo -- sugar pill).  Using a larger sample (patient size) allows the testing to be statistically accurate in the regulatory agencies eyes.




Step 5:



If the drug is successful during all three phase testing trials in humans, the pharmaceutical company will submit the entire data (pre-clinical and clinical testing - phase 3) to the FDA for approval to manufacture and market the drug to treat the desired disease.  The FDA approval indicates that the company can indeed go through and manufacture the drug to treat the disease.  Although, throughout the drug's lifetime, the FDA will be keeping tabs on the drugs efficacy and can ask for paperwork at any time or additional testing.



Obviously, the steps outlined above requires the coordination of a large amount of people and data.  Think about just one perspective -- i.e., the research aspect of the process.  This by itself would be overwhelming.  Then add on another perspective of the process -- i.e., the legal challenges.  Not to mention other aspects like marketing and branding the drug.  All together, there is no wonder why the cost is so high.  But pharmaceutical companies still reap a large profit from a blockbuster drug -- so don't feel too bad for them.



Recently, the rules have changed for the drug manufacturers and additional testing is required.  A perfect example is the testing for 'alcohol dose dumping' - which I recently became aware of.  In the next section, I will introduce you to this phenomenon -- which as you will see will require more testing and money associated with the production of the drug.

More Requirements?

As I just mentioned, recently (as in 2005) the FDA has changed the testing requirements to add more testing.  Testing the drug in its native environment (inside the patient during a 3 phase trial) is not sufficient enough.  Now, the addition of 'dose-dumping' testing is required of companies.  I was unaware of the phenomenon until I stumbled upon a document on the FDA website titled "Mitigating the Risks of Alcohol Induced Dose Dumping from Oral Sustained or Controlled Release Dosage Forms: Proposed Regulatory Procedures."



Here is a brief background on 'dose-dumping' from the FDA report:

Unintended, rapid drug release in a short period of time of the entire amount or a significant fraction of the drug contained in a modified release dosage form is often referred to as “dose dumping”. Depending on the therapeutic indication and the therapeutic index of a drug, dose-dumping can pose a significant risk to patients, either due to safety issues or diminished efficacy or both. Generally dose-dumping is observed due to a compromise of the release-rate-controlling mechanism. The likelihood of dose-dumping for certain modified release products when administered with food has been recognized for about twenty years and a regulatory process established to address it (1-2).

Some modified-release oral dosage forms contain drugs and excipients that exhibit higher solubility in ethanolic solutions compared to water. Such products can be expected to exhibit a more rapid drug dissolution and release rate in the presence of ethanol.  Therefore, in theory, concomitant consumption of alcoholic beverages along with these products might be expected to have the potential to induce dose dumping. This potential mechanism leading to dose-dumping from an oral modified-release dosage form has not previously attracted attention in the pharmaceutical science literature or in regulatory assessment process. There are many reasons this may not have previously been considered, amongst these reasons is that there may have existed a general assumption that a clinically insignificant difference in drug release rate would be expected with concomitant ethanol consumption in vivo. A study conducted over twenty years ago (3) and the absence of a clear post-marketing signal pointing to alcohol inducing dose dumping may have reinforced the latter assumption. 

Drugs are designed by the manufacturer to have certain desirable time release characteristics.  To have a drug release all of the active ingredients at once may be not just undesirable but have extremely adverse reactions to a patient.  Therefore, considering the impact of taking medications on an empty stomach or full stomach are normal.  Additionally, with more precision medicine comes optimization in the form of adding other factors (like alcohol and other medications) which might result in degraded performance of the drug.  Of course, requiring extra considerations requires more testing which in turn requires more cost.  Although, one important factor to keep in mind when considering the cost of a prescription drug along with sympathizing with the manufacture is the stage of the process of change.


Where are the changes going to affect the 'bottom line'?


If the changes by the FDA require methodology change at the stage of 'basic research' then the cost is on the 'tax payer' and not the pharmaceutical industry.  Whereas, in the case above, the drug has already been manufactured and the change (including the solubilization by alcohol) is after the formulation stage and relies on the pharmaceutical company's 'bottom line.'  This cost cuts into the profit of the drug by adding more cost into the design of the drug to avoid 'dose-dumping'.



Based on the example above, the cost can be incurred by pharmaceutical companies or the government (i.e., tax-payer).  Our new President-elect Trump has stated in a recent interview with 'Time magazine' titled "Donald Trump on Russia, Advice from Barack Obama and How He Will Lead" that he is "... going to bring down drug prices. I don’t like what’s happened with drug prices."  That sounds encouraging.



The question is where is the cost going to be cut from -- government side or pharmaceutical side.  Either side will have a respective impact on Research & Design in the future for science and drug development.  Furthermore, as you can see, any change has an effect on cost.  Let's look at a positive change for better drug design below.   The change directly impacts the above problem of 'dose-dumping.'



An article recently on the website 'Research & Development' titled "New Discovery Could Help Oral Medicines Work Better" highlights new developments which are costly to incorporate into new drugs.  Although, in the article, research chemists funded by Dow -- have designed certain molecules (differing chain lengths) that help certain medications (or drugs) dissolve better in the stomach.



Again, the problem is with the dissolution of a medication inside the stomach (precision is desirable) as stated below from the article:

One of the biggest challenges for pharmaceutical companies when developing oral medications is to ensure that the body will fully absorb the drug molecules. Many therapeutic structures do not easily dissolve on the molecular level, which means they are less effective. In that case, the dose must be increased for patients, which may increase side effects.

"A way to explain the differences in solubility of medicines is to think of how sugar easily dissolves in water and is rapidly absorbed by your digestive system, whereas sand doesn't dissolve in water and if swallowed, would pass right through the digestive system," said Theresa Reineke, a chemistry professor in the University of Minnesota's College of Science and Engineering and lead researcher on the study.

Drug companies add substances, called excipients, to help the medicines dissolve in the stomach and intestinal fluid, but there have been few improvements in recent years to this decades-old technology. The process outlined in the study is a major breakthrough that revolutionizes the process of making drug structures more soluble in the body so that they are better absorbed.

Funded by Dow, researchers examined two medications—phenytoin, an anti-seizure drug, and nilutamide, a drug used to treat advanced-stage prostate cancer. The team used automated equipment at Dow to synthesize long-chain molecules. Their efficiency as excipients with these drugs were then tested with facilities at the University of Minnesota, including the Characterization Facility located in the University's College of Science and Engineering. One particular excipient discovered by this research allowed these insoluble drugs to fully dissolve in simulated intestinal fluid in a test tube. When they tested phenytoin with the new excipient in rat models, it promoted drug absorption three times better than the previous formulation.

The overall benefit of the discovery is that the molecules that were made could impact a range of medications, not just a couple.  Meaning, that the development could impact the field of 'oral dosing' -- medications taken by mouth -- which would be huge.  The problems and solutions above illustrate the extent to which the government and academia along with the pharmaceutical industry have to go to get a 'working pill' to your mouth or solution to inject intravenously.  After reading the above processes, you should step back and consider again why a drug costs so much money to develop.

Conclusion...

I have outlined above the steps that add up to 20 years and roughly $1 billion worth of research/marketing/legal work that goes into the drug design process.  Too many people have problems with the availability of prescription drugs due to cost.  Drug companies should be able to recoup the cost of research and design behind the drug that is sold at market.  Although, when drugs are given away or sold to foreign countries at a hugely reduced cost, concerned citizens start to speak up here in the U.S. regarding the inherent unfairness behind such disparities.



Furthermore, when a pharmaceutical company increases (by hundred of percent) the price of a drug for an outrageous claim in change of design, citizens should speak up to their elected officials (politicians) who have the ability to conduct a congressional hearing.   There are recent examples that justify this advice.


An example is the pharmaceutical company Mylan and the congressional trial where the CEO Heather Bresch had to testify in order to justify a 400% increase in cost for the EpiPen treatment.  After testifying, representatives thought that they were justified.  Although, in a recent article in 'Drug Development & Discovery' titled "Mylan CEO Discusses EpiPen Price Hikes at Forbes Event" Mylan CEO Heather Bresch tries to explain the increase in her company's product 'EpiPen':

Herper asked what specific value was added to these products after Mylan acquired them in 2007, which prompted Bresch to present two versions of the EpiPen on stage to illustrate how the pen has evolved over time.  She explained the pen in its initial form confused patients making it difficult to operate leading to accidental sticks whereas the latest iteration was safer and more ergonomic.

Plus, the CEO elaborated that Mylan spent over $1 billion implementing lobbying efforts to increase access to EpiPens and awareness regarding severe allergic reactions noting the company has been able to reach 80 percent more patients since acquiring the EpiPen in 2007, according to Business Insider.

The above reason sounds suspicious to say the least.  I don't buy the excuse.  For the reason listed above in the steps of drug discovery process, changing the 'ergonomic features' of a product most likely does not involve a large cost.  Especially from the standpoint of the regulatory process.  The underlying product (active drug and formulation) is not changed.  Therefore, I remain skeptical of Heather Bresch's reason for increasing the cost.



Furthermore, in closing, she stated the most accurate (and honest) aspect of the pharmaceutical industry in the following statement:

There’s a lack of understanding of where that full list… [price]…goes and how it is divided in the system,” Bresch told the audience. “The pharmaceutical system was not built on the idea of consumer engagement.”

True.  I could not agree more -- more transparency is needed regarding the way the pharmaceutical industry operates.  Which is why the public remains skeptical of the practices and pricing of the drugs that hit the market to treat diseases in the United States.  Stay tuned for more on this subject.



Until next time, Have a great day!