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.
Last week, I received an email from the trade magazine "Laboratory Equipment" with the daily e-mail alerts to the most recent research being released. Usually, scientists will only read the top science journals like "Nature" and "Science". I like reading those journals too and receive their emails also. Anyways, in this particular e-mail was an article that almost knocked me off my seat behind my desk. The article was titled "Trump Administration Bringing Federal Agencies, Science and Funds to Heel" and contained the following introduction shown below:
The new directives from various federal agencies have started to centralize the message and mission of the various agencies – including the Environmental Protection Agency and the U.S. Department of Agriculture.
The USDA’s Agricultural Research Service and its employees are all banned from sharing information with the press and public, according to a Monday email acquired and published online by BuzzFeed.
“Starting immediately and until further notice, ARS will not release any public-facing documents,” wrote Sharon Drumm, chief of staff for the Service. “This includes, but is not limited to, news releases, photos, fact sheets, news feeds, and social media content.”
All requests for public information are now going through the agency’s office of communications in Washington, D.C., the site reported.
The Environmental Protection Agency has frozen all its grant programs – and also prohibited any contact with the press and the public through releases, statements, social media blasts, and other forms of communication, according to another internal message obtained by The Huffington Post.
The EPA freeze also includes honoring existing contracts, according to ProPublica. The grants and expenditures include research funding, air quality monitoring, pollution cleanups, and other ongoing endeavors. The freeze was unveiled by an anonymous EPA staffer – considered unusual for a transition move of the sort. Myron Ebell, who led Trump’s EPA transition but who has since returned to the Competitive Enterprise Institute, told ProPublica the extent of the Trump administration’s actions to review all policies and expenditures is more extreme than in previous presidential transitions.
After reading the above excerpt from the article, I was shocked. The following questions arose immediately:
1) Can the President restrict the research that the public sees that is 'tax-payer' funded? 2) How will the public access science that is released through federal agencies"? 3) What are the implications of such measures for the public at large?
The questions above are the result of the news. I am still shocked to see that this occurs. Although, in the article, the author did state through interviews that the process is normal with the transition of each incoming Presidential administration. In the paragraphs below, I show through examples of the scope and implications of such measures implemented by President Trump.
An Open Letter to President-Elect Trump and the 115th Congress
Scientific knowledge has played a critical role in making the United States a powerful and prosperous nation and improving the health and well-being of Americans and people around the world. From disease outbreaks to climate change to national security to technology innovation, people benefit when our nation’s policies are informed by science unfettered by inappropriate political or corporate influence.
To build on this legacy and extend the benefits of science to all people, including Americans who have been left behind, the federal government must support and rely on science as a key input for crafting public policy. Policy makers and the public alike require access to high-quality scientific information to serve the public interest. There are several actions Congress and the Trump administration should take to strengthen the role that science plays in policy making.
First, creating a strong and open culture of science begins at the top. Federal agencies should be led by officials with demonstrated track records of respecting science as a critical component of decision making. Further, recognizing that diversity makes science stronger, administration officials should welcome and encourage all scientists regardless of religious background, race, gender, or sexual orientation.
Second, Congress and the Trump administration should ensure our nation’s bedrock public health and environmental laws—such as the Clean Air Act and the Endangered Species Act—retain a strong scientific foundation, and that agencies are able to freely collect and draw upon scientific data to effectively carry out statutory responsibilities established by these laws. They should also safeguard the independence of those outside the government who provide scientific advice.
Third, Congress and the Trump administration should adhere to high standards of scientific integrity and independence in responding to current and emerging public health and environmental threats. Decision makers and the public need to know what the best-available scientific evidence is, not what vested interests might wish it to be. Federally funded scientists must be able to develop and share their findings free from censorship or manipulation based on politics or ideology. These scientists should, without fear of reprisal or retaliation, have the freedom and responsibility to:
1) conduct their work without political or private-sector interference
2) candidly communicate their findings to Congress, the public, and their scientific peers
3) publish their work and participate meaningfully in the scientific community
4) disclose misrepresentation, censorship, and other abuses of science
5) ensure that scientific and technical information coming from the government is accurate
Finally, Congress and the Trump administration should provide adequate resources to enable scientists to conduct research in the public interest and effectively and transparently carry out their agencies’ missions. The consequences are real: without this investment, children will be more vulnerable to lead poisoning, more people will be exposed to unsafe drugs and medical devices, and we will be less prepared to limit the impacts of increasing extreme weather and rising seas.
These steps are necessary to create a thriving scientific enterprise that will strengthen our democracy and bring the full fruits of science to all Americans and the world. The scientific community is fully prepared to constructively engage with and closely monitor the actions of the Trump administration and Congress. We will continue to champion efforts that strengthen the role of science in policy making and stand ready to hold accountable any who might seek to undermine it.
The letter was signed by over 5,500 scientists. The take-home message to President Trump is that scientists are watching made under your guidance to make sure that politics is not interfering with the natural progression of science. Meaning, that science research grants funded by federal agencies are not in any way hindered by the political process. The President can decide which research has priority over other research -- which is a direct interference of politics in science.
In past administrations, there has been varying degree of political interference. Which is why the issue is brought up by scientists at the beginning of every administration. Here is another excerpt from the Union of Concerned Scientists website in an article titled "2300 Scientists from All Fifty States Pen Open Letter to Incoming Trump Administration" which was a precursor to the actual letter above:
The letter lays out several expectations from the science community for the Trump administration, including that he appoint a cabinet with a track record of supporting independent science and diversity; independence for federal science advisors; and sufficient funding for scientific data collection. It also outlines basic standards to ensure that federal policy is fully informed by the best available science.
For example, federal scientists should be able to: conduct their work without political or private-sector interference; freely communicate their findings to Congress, the public and their scientific peers; and expose and challenge misrepresentation, censorship or other abuses of science without fear of retaliation.
There are many gears to the motor which drives science funding. An incoming administration is the master part of the motor -- the circuit board. The various gears are driven by both houses of congress -- which ultimately delivers the funds to the federal agencies to disperse. The houses of congress are driven by elected representatives -- who respond to their constituents who elect them. Therefore, science is funded by the people of the United States. Which leads me to the next point regarding science funding.
To be fair, the lack of funding for science cannot all be laid on the shoulders of government. Scientists themselves are part of the problem. Scientists need to get out of their labs and communicate the work (and its) importance to the public. Further, scientists could point out to the general public that the results of their "tax-payer" funded research is available for free online. I will show you very shortly what I mean by that.
Science outreach is critical to engage the young in pursuing future careers in science. Just a couple of weeks ago, I participated in a science fair contest as a judge. The experience was very meaningful for me along with the 3rd graders with whom I got to engage with (through interviews) regarding their projects. I wrote a blog on the experience which came out recently.
As a disclaimer, I thought that I needed to distribute the blame for lack of funding throughout the science community and government. Part of the issue is how we (scientists) disseminate the work of experimental observation. The results are usually typed up into academic journals which are set up high on a pedestal and unavailable to the general public except through a high paywall. Yes, the dissemination of science is too complicated and out of control as far as cost. Most of the cost goes to the publishers which make scientists more angry.
Try to access an article from a premier journal like "Science" or "Nature" and look at the cost associated with a given article. You will find that an article can run as low as $18 for a copy. Remember, the results of the article were funded by 'tax-payer' dollars.You (the public) funded the research -- should the results not be freely available to you? This is a topic for debate and also a reason for the continuing emergence of "open-access" journals publishing science. The argument against "open-access" journals is the lack of quality. Although, with the audience reading the journals, mistakes are found more readily than before. Especially with the competition among researchers for grant funding. Competition is driving innovation and error detection.
In the paragraphs below, I will show you how to access the published results of our 'tax-payer' funded research from a few regulatory sites. My methodology in searching can be extended to any regulatory agency. Meaning, you can go on any regulatory agency site (FDA, USDA, NIH, NSF, EPA, DARPA, DOE, DOD, etc.) and look for press releases that give a short description of the research and the results along with a reference to the journal in which the work was published.
Where To Find Scientific Results?
As I just mentioned, each regulatory agency (those I just mentioned above) has a website and offers press releases which give the public an idea of the research that was funded by the public and the results along with a reference to the original publication. The dissemination of science funded research is critical for the public. Why?
What if you had a rare type of cancer in which there was an ongoing trial to test a treatment? Would you like to pay money to find out the results which you pre-paid for through your taxes? What about if your town just received a small grant to improve the drinking water? Would you be interested in the amount of the grant and the scope of the project (how the money can be spent)?
Questions like these might be answered by various regulatory agencies sites through their respective 'news room' which offers press releases. Below are a few images (screenshots) of federal agencies websites. I took a screenshot highlighting the press releases.
Regulatory Websites
As I mentioned above in the introduction and elaborated in the first section, restricting the publics ability to view science research which has been published is a serious threat. In this section, I will show you some of the websites from various government regulatory agencies. After viewing and reading this section, the potential threat of shutting down the communication of science to the public will become vary apparent. And remember, the research, grants, and news press releases are all paid by our (the U.S. public) tax-dollars. We own fund the research, we own the results of the research!
The United States Environmental Protection Agency[2] (EPA or sometimes USEPA) is an agency of the Federal government of the United States which was created for the purpose of protecting human health and the environment by writing and enforcing regulations based on laws passed by Congress.[3]....
The agency conducts environmental assessment, research, and education. It has the responsibility of maintaining and enforcing national standards under a variety of environmental laws, in consultation with state, tribal, and local governments. It delegates some permitting, monitoring, and enforcement responsibility to U.S. states and the federally recognized tribes. EPA enforcement powers include fines, sanctions, and other measures. The agency also works with industries and all levels of government in a wide variety of voluntary pollution prevention programs and energy conservation efforts.
Below I show an image of the webpage that you would encounter if you visited the site "www.epa.gov":
As you can see, the top of the page has a header with the following drop down menus under: "Environmental Topics", "Laws & Regulations", and "About EPA". The amount of information contained within the pages under these menus is absolutely amazing. For instance, under "Environmental Topics" a list includes the following topics to choose from:
1) Air
2) Bed bugs
3) Chemicals and Toxics
4) Environmental Information by Location
5) Greener living
6) Health
7) Land, Waste, and Cleanup
8) Lead
9) Mold
10) Pesticides
11) Radon
12) Water
13) A-Z Index
Imagine if you were wondering about dangerous chemicals like mercury, then proceeding the the 'Chemicals and Toxics' page would lead to a wealth of knowledge. Any new regulations and research into the toxicity of mercury could be found on this site.
Proceeding down the webpage, there are three subsections shown below: "Popular Topics", "News", and "Your Community".
If you were to 'click' on a highlighted news story such as "$12.7M for Small Drinking, Waste Water Systems," you would be directed to the webpage shown below:
This might be of interest to you if you had recently applied for a grant to overhaul your home 'well' and 'wastewater' systems as highlighted in the introduction:
The U.S. Environmental Protection Agency (EPA) is awarding $12.7 million in grants to help small drinking and wastewater systems and private well owners. Water systems staff will receive training and technical assistance to improve operations and management practices, promote system sustainability, and better protect public health and the environment.
These grants sound very useful in providing safe drinking water. None of us need to be reminded of the disaster in Flint (Michigan) with their tainted water supply to know that investments into clean water is a good investment toward a healthy water system later down the line.
Although, grants and regulatory practices are not the only information contained on the EPA's website. There is a blog titled "Our Planet, Our Home" which details various actions taken and success stories by the EPA. Click on the blog page and stories like the one shown below will appear.
Who is not interested in learning about the actions taken by the EPA along with future plans to clean up communities that have been abandoned by factories which moved overseas with their jobs. The EPA site is amazing and paid for by us -- the U.S. Taxpayer dollars -- check it out.
Could you imagine not having access to the information above and relying solely on the words of politicians?
2) U.S. Food & Drug Administration:
The next regulatory agency is the United States Food & Drug Administration which regulates a wide range of topics from everything we eat to everything we inhale. Here is an excerpt from the 'Wikipedia' page for the U.S. FDA below:
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed[5] and veterinary products.
The webpage is shown below:
A few of the topics on the site with drop down menus are:
Pretty much all consumer products are covered by the FDA if they involve our body. Shown below is the bottom part of the webpage which is filled with important information.
For instance, if you were a patient who suffers from Chronic Idiopathic Constipation. Furthermore, you just heard about the possibility of the FDA approving a new treatment (drug) called Trulance. You could visit the FDA website and look under the subsection "News & Events" to find a story about the recent approval of the drug on January 19, 2017. How good is that?
Having access to the information contained on the FDA website is a matter of life and death in some cases. Additionally, being able to access critical information on hot topics like 'electronic cigarettes' can help clarify misconceptions and possibly reduce addiction to nicotine products. Understanding where the science is at a given point is the job of the FDA from a regulatory position.
But what about the science research that is ongoing? What if you are interested in basic research into a disease mechanism? Where do you find out information regarding a disease? Where would you find information on different forms of diabetes? Where do you look for that type of information?
The FDA has information regarding the regulatory procedures for treating the ailments listed above. Further, the FDA would approve a drug to be used to treat two different diseases (orphan drugs). But when you are looking for information into the state of government funded research into a disease, you would search on the next two regulatory sites -- which are also publicly funded by our tax-dollars.
3) National Institutes of Health:
The National Institutes of Health has a mission that is stated simply on the "Wikipedia" page shown below:
The National Institutes of Health (NIH) is a biomedical research facility primarily located in Bethesda, Maryland. An agency of the United States Department of Health and Human Services, it is the primary agency of the United States government responsible for biomedical and health-related research. The NIH both conducts its own scientific research through its Intramural Research Program (IRP) and provides major biomedical research funding to non-NIH research facilities through its Extramural Research Program.
With 1,200 principal investigators and more than 4,000 postdoctoral fellows in basic, translational, and clinical research, the IRP is the largest biomedical research institution in the world,[3] while, as of 2003, the extramural arm provided 28% of biomedical research funding spent annually in the U.S., or about US$26.4 billion.[4]
The NIH comprises 27 separate institutes and centers that conduct research in different disciplines of biomedical science. The IRP is responsible for many scientific accomplishments, including the discovery of fluoride to prevent tooth decay, the use of lithium to manage bipolar disorder, and the creation of vaccines against hepatitis, Haemophilus influenzae (HIB), and human papillomavirus (HPV).[5]
The webpage for the National Institutes of Health is shown below:
The header on the top of the website contains the following topics for 'drop down menus': .... Notice on the lower set of boxes are titles of diseases which have information and updates about the research behind them. If you clicked on the highlighted text for 'diabetes' the following webpage would pop up on your screen which is shown below:
Information regarding the nature of diabetes along with the various types of diabetes that exist.
What if you suffered from the debilitating disease of 'multiple sclerosis' and were searching for a new treatment? This page would interest you -- specifically the first topic titled "Stem cell transplants may induce long-term remission for multiple sclerosis."
The following introduction reads:
New clinical trial results provide evidence that high-dose immunosuppressive therapy followed by transplantation of a person's own blood-forming stem cells can induce sustained remission of relapsing-remitting multiple sclerosis (MS), an autoimmune disease in which the immune system attacks the central nervous system.
Five years after receiving the treatment, called high-dose immunosuppressive therapy and autologous hematopoietic cell transplant (HDIT/HCT), 69 percent of trial participants had survived without experiencing progression of disability, relapse of MS symptoms or new brain lesions. Notably, participants did not take any MS medications after receiving HDIT/HCT. Other studies have indicated that currently available MS drugs have lower success rates.
The rest of the brief article describes the study further in depth and gives the original journal where the research was published. Information like the results above are hope of life for a certain portion of the population who suffer from Multiple Sclerosis. The following question comes to mind when thinking of the value of the excerpt above:
Imagine if you had a form of Multiple Sclerosis that did not respond to any of the medication or treatment available on the market today?
Investing in the research performed through the funding by the National Institutes of Health is extremely important. We need to continue to support these agencies. The research above is steered toward the field of biomedicine. What about other areas of science? Physics? Chemistry? Who funds these areas of research? Read on below to find out.
4) National Science Foundation (NSF):
Next is the basic research counterpart to the NIH, the National Science Foundation. The mission of the National Science Foundation is shown below taken from the "Wikipedia" page:
The National Science Foundation (NSF) is a United States government agency that supports fundamental research and education in all the non-medical fields of science and engineering. Its medical counterpart is the National Institutes of Health. With an annual budget of about US$7.0 billion (fiscal year 2012), the NSF funds approximately 24% of all federally supported basic research conducted by the United States' colleges and universities.[2] In some fields, such as mathematics, computer science, economics, and the social sciences, the NSF is the major source of federal backing.
The research conducted that is funded by the National Science Foundation is wide in scope. Topics span from physical science through the life science along with engineering and computer science to name a few. For example, a recent blog post that I wrote regarding how chemists discover drugs has a short video which explains how funding for new drugs emerge from agencies like the NSF and NIH.
The webpage for the National Science Foundation is shown below:
Across the top of the page are the following drop down menus: "Research Areas," "Funding," "Awards," "Document Library," "News," and "About NSF." If you were to choose the first drop down menu the following image would appear as shown below:
With the following choices of subjects to choose from:
1) Biological Sciences (BIO)
2) Computer and Information Science and Engineering (CISE)
3) Education and Human Resources (EHR)
4) Engineering (ENG)
5) Environmental Research and Education (ERE)
6) Geosciences (GEO)
7) Integrative Activities (OIA)
8) International Science and Engineering (CISE)
9) Mathematical and Physical (MPS)
10)Social, Behavioral and Economic Sciences (SBE)
If you were to choose the first subject "Biological Sciences" then the following webpage would appear below:
Notice that there is a section titled "News" in the lower right-hand corner of the image above. If you were to click on that story, the following webpage would appear with a development in the area of genetically modified tomatoes -- a breakthrough:
The story reported is brief and to the point regarding the funded research and its importance:
Some consumers crave tastier tomatoes than those available at the supermarket. Now, scientists at the University of Florida Institute of Food and Agricultural Sciences (UF/IFAS) and their partners have found a way to get tomatoes to produce the compounds that make them more flavorful.
Their findings were published today in the journal Science.
"Around the world, the tomato is one of the most popular foods," says Gert de Couet, director of the National Science Foundation (NSF) Division of Integrative Organismal Systems, which supported the research. "This state-of-the-art analysis sets the stage to return it to the taste of decades ago by breeding informed by molecular genetics."
Step one for UF/IFAS horticultural scientist Harry Klee and his colleagues involved finding out which of the hundreds of chemicals in a tomato contribute the most to taste.
Next, Klee said, they asked: "What's wrong with modern tomatoes?" As it turned out, modern tomatoes lack sufficient sugars and volatile chemicals critical to better flavor. Those traits have been lost over the past 50 years, says Klee, the Science paper's lead author.
The researchers began looking at tomato alleles (one of two or more alternative forms of a gene that arise by mutation and are found at the same place on a chromosome). Alleles determine specific traits in organisms, whether tomatoes or people. Klee likened this to how different versions of genes in humans influence traits such as height, weight and hair color.
"We wanted to identify why modern tomato varieties are deficient in flavor chemicals," Klee said. "It's because they have lost the more desirable alleles of a number of genes."
The scientists then zeroed in on the locations of those alleles in the tomato genome. Using a technique called a genome-wide association study, they mapped genes that control synthesis of all the "tasty" chemicals. Informed by genetic analysis, they replaced undesirable alleles in modern tomato varieties with desirable alleles.
"We identified the important factors that have been lost and showed how to move them back into modern types of tomatoes," Klee said. "We're just fixing what has been damaged over the last half-century to push them back to where they were, taste-wise. We can make the supermarket tomato taste noticeably better."
Breeding a more flavorful tomato could benefit consumers as well as the tomato industry. According to the Department of Agriculture, the U.S. is second only to China in worldwide tomato production.
Florida and California account for up to three-quarters of all commercially produced fresh tomatoes in the U.S. As of 2014, Florida growers produced 33,000 acres of tomatoes worth $437 million annually, according to UF/IFAS research.
But breeding a better tomato will take time, Klee says. The genetic traits discovered in the study may take three or four years to produce new varieties.
Can you imagine if we were still stuck in the 'dark ages' of growing tomatoes without science?
There would be a significant amount of loss of crops due to infestation of insects to start with. Weathering would account for more loss. Additionally, not all crops survive the travel from farm to grocery store aisle. Genetically modifying our food has saved us a large amount of trouble in terms of loss of food in the super market.
The science outlined above is amazing. The fact that scientists were able to discover the genes associated with the production of chemicals which give tomatoes their flavor is awesome and a testament to the advancement that we have seen with science over the decades. That was just one section of the NSF website. Another part of the front webpage is shown below -- which states the awards of grant applications. If you wanted to research a basic science project, you could write the NSF:
Without the NSF and the NIH, there would be literally very few science research projects underway in the United States. These two agencies are responsible for a large component of our educational system. The grants that are awarded to universities around the country help educate students studying at the university and give them an opportunity to engage in research. The funding that comes out of these agencies creates the scientists and engineers of tomorrow!
5) United States Department of Agriculture (USDA):
The United States Department of Agriculture has a mission that is focused around food sources. Here is an excerpt from the introduction on the "Wikipedia" page for the agency:
The United States Department of Agriculture (USDA), also known as the Agriculture Department, is the U.S. federal executive department responsible for developing and executing federal laws related to farming, agriculture, forestry, and food. It aims to meet the needs of farmers and ranchers, promote agricultural trade and production, work to assure food safety, protect natural resources, foster rural communities and end hunger in the United States and internationally.
In case, you are wondering how the work of the USDA differentiates from basic research by the NIH and NSF, here is the overview:
Many of the programs concerned with the distribution of food and nutrition to people of America and providing nourishment as well as nutrition education to those in need are run and operated under the USDA Food and Nutrition Service. Activities in this program include the Supplemental Nutrition Assistance Program, which provides healthy food to over 40 million low-income and homeless people each month.[3] USDA is a member of the United States Interagency Council on Homelessness,[4] where it is committed to working with other agencies to ensure these mainstream benefits are accessed by those experiencing homelessness.
The USDA also is concerned with assisting farmers and food producers with the sale of crops and food on both the domestic and world markets. It plays a role in overseas aid programs by providing surplus foods to developing countries. This aid can go through USAID, foreign governments, international bodies such as World Food Program, or approved nonprofits. The Agricultural Act of 1949, section 416 (b) and Agricultural Trade Development and Assistance Act of 1954, also known as Food for Peace, provides the legal basis of such actions. The USDA is a partner of the World Cocoa Foundation.
The webpage for the U.S.D.A is shown below:
Across the top of the webpage are a few drop down menus with the following options: "Topics," "Programs and Services," "Newsroom," and "Blog." If you were to choose the option "Newsroom," the following list would appear as shown below:
With the following choices:
1) Agency News Releases
2) Agency Reports
3) Creative Media & Broadcast Center
4) Email Subscriptions
5) In Case You Missed It...
6) Latest Releases
7) New Media
8) Radio Newsline and Features
9) TV Feature Stories
10) Results
11) RSS Feeds
12) Transcripts and Speeches
13) USDA Live
If you were to choose the first option "Agency News Releases" the following webpage would appear as shown below:
The webpage is full of news releases which are up to date results of money spent by the USDA. If you were looking to see if the government was interested in investigating the problem of 'citrus greening' which plagues citrus farmer, this is the page where you would visit to find out. By clicking on the first story titled "USDA Invests $13.6 million in Citrus Greening Research" the following webpage would appear with the up to date news regarding the research that is being funded by the USDA.
For those who are not familiar with the problem of 'Citrus Greening' here is the first few paragraphs of the story above for an introduction:
WASHINGTON, Jan. 19, 2017 - The U.S. Department of Agriculture's (USDA) National Institute of Food and Agriculture (NIFA) today announced four grants totaling more than $13.6 million to combat a scourge on the nation's citrus industry, citrus greening disease, aka Huanglongbing. The funding is made possible through NIFA's Specialty Crop Research Initiative (SCRI) Citrus Disease Research and Extension Program, authorized by the 2014 Farm Bill.
"The economic impact of citrus greening disease is measured in the billions," said NIFA Director Sonny Ramaswamy. "NIFA investments in research are critical measures to help the citrus industry survive and thrive, and to encourage growers to replant with confidence."
Huanglongbing (HLB) is currently the most devastating citrus disease worldwide. HLB was first detected in Florida in 2005 and has since affected all of Florida's citrus-producing areas leading to a 75 percent decline in Florida's $9 billion citrus industry. Fifteen U.S. States or territories are under full or partial quarantine due to the presence of the Asian citrus psyllid (ACP), a vector for HLB.
Wow! I was not aware of the amount of money in losses that was due to the disease of HLB. The next time that you eat an orange or drink a glass of orange juice take a minute to think about the citrus disease of HLB. Further, about how the funding that your tax-payer dollar went toward is to find a cure to the disease. Enjoy that citrus!
What about food labeling? Would that be covered by the FDA? Or the USDA?
The "Food Safety and Inspection Services" operates underneath the USDA. By navigating the USDA site in search of food labeling, the following webpage would appear as shown below:
Clicking on the first story titled "USDA Revises Guidance on Date Labeling to Reduce Food Waste" will take you to the webpage below with the story:
The news release is of a law that will go into effect soon to ensure all food products contain the label "best if used by":
WASHINGTON, Dec. 14, 2016 – The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) today issued updated information on food product labeling, including new guidance aimed at reducing food waste through encouraging food manufacturers and retailers that apply product dating to use a “Best if Used By” date label.
“In an effort to reduce food loss and waste, these changes will give consumers clear and consistent information when it comes to date labeling on the food they buy,” said Al Almanza, USDA Deputy Under Secretary for Food Safety. “This new guidance can help consumers save money and curb the amount of wholesome food going in the trash.”
Except for infant formula, product dating is not required by Federal regulations. Food manufacturers frequently use a variety of phrases, such as “Sell-by” and “Use-by” on product labels to describe quality dates on a voluntary basis. The use of different phrases to describe quality dates has caused consumer confusion and has led to the disposal of food that is otherwise wholesome and safe because it is past the date printed on the package.
FSIS is changing its guidance to recommend the use of “Best if Used By” because research shows that this phrase is easily understood by consumers as an indicator of quality, rather than safety.
USDA estimates that 30 percent of food is lost or wasted at the retail and consumer level. This new guidance builds on other recent changes FSIS has made to facilitate food donation and reduce food waste. In January 2016, FSIS issued Directive 7020.1, which made it easier for companies to donate products that have minor labeling errors, such as an incorrect net weight. FSIS has also begun recognizing food banks as “retail-type” establishments, which allows food banks (under certain circumstances) to break down bulk shipments of federally-inspected meat or poultry products, wrap or rewrap those products, and label the products for distribution to consumers. In 2016, FSIS enabled 2.6 million pounds of manufacturer donations.
Comments on this revised guidance may be submitted through the Federal eRulemaking Portal at www.regulations.gov or by mail to the U.S. Department of Agriculture, FSIS, Docket Clerk, Patriots Plaza III, 355 E St. S.W., 8-163A, Mailstop 3782, Washington, DC 20250-3700. All comments submitted must include docket number FSIS-2016-0044. FSIS will accept comments for 60 days.
Reducing food loss and waste is core to USDA’s mission. Since 2009, USDA has launched new and ongoing initiatives to reduce food waste. In 2013, USDA the Environmental Protection Agency (EPA) launched the U.S. Food Waste Challenge, creating a platform for leaders and organizations across the food chain to share best practices on ways to reduce, recover, and recycle food loss and waste. In 2015, USDA and EPA set the first-ever national food waste reduction goal of 50 percent by 2030 to reduce the amount of wasted food in landfills.
Food waste is a major issue plaguing the world. In 2015, the amount of food waste added up to $165 billion which equates to a total of 35 million tons of food. If we had a better idea of when the food would actually "spoil" by then more food would end up nourishing us rather than in our landfills. Information regarding rules and regulations are put on the site for the consumers to ensure the maximum use of food for nourishment. Additionally, if a vendor does not have the proper labeling, you can report the manufacturer to the USDA.
6) Department of Energy (DOE):
The Department of Energy is primarily concerned with all aspects of energy as highlighted in the introduction offered on the "Wikipedia" page for the agency:
The United States Department of Energy (DOE) is a Cabinet-level department of the United States Government concerned with the United States' policies regarding energy and safety in handling nuclear material. Its responsibilities include the nation's nuclear weapons program, nuclear reactor production for the United States Navy, energy conservation, energy-related research, radioactive waste disposal, and domestic energy production. It also directs research in genomics; the Human Genome Project originated in a DOE initiative.[3] DOE sponsors more research in the physical sciences than any other U.S. federal agency, the majority of which is conducted through its system of National Laboratories.[4]
By the description in the excerpt above, one might be tempted to think that the primary goal of the DOE is to control nuclear material. The agency is tasked with the energy production for the United States and energy security as well. These two tasks alone are a huge feat if you think about providing electricity for the entire nation and secure energy too (a potential national security issue).
Below is an image of the webpage for the Department of Energy:
The information available on the site is accessible through the drop down menus above: "Public Services," "Science & Innovation," "Energy Star," "About ENERGY.GOV," and "Office." If you were to choose the drop down menu labeled "Public Services" would appear shown below:
The following options are:
1) Public Services Home
2) Vehicles
3) Manufacturing
4) Energy Economy
5) State & Local Government
6) Home
7) Commercial Buildings
8) National Security & Safety
9 ) Funding & Financing
Upon choosing the option "Vehicles" the webpage below appears:
The image above is of a video made by the DOE to educate the public on the subject of "Electric Vehicles." The video is shown below -- less than 3 minutes in length:
Remember that in each of these agencies, education is a major component. There is no use introducing a new technology to the public if the public is not informed on the use of the technology. Often the public will instantly want to cut funding to these agencies forgetting that grant funding is only part of the expense. Others are education, regulation, and national security along with administration costs.
The debate over how much electric vehicles should play a role in our society is based on their efficiency and reliability. If the vehicle cannot get us to our destination, then the car is useless (no really, some people think this). Electric vehicles are improving at an unprecedented rate and playing a greater role in today's society. And information regarding the energy developments in the United States are held for FREE on this site. How lucky are we? Super lucky.
To put this wealth of information and resources into context, lets briefly look at another country. In a recent article from the website "Issues" titled "Of Sun Gods and Solar Energy" India is profiled for the emergence of solar energy. The author studies the diffusion of solar energy technology across the nation. Here is an excerpt to think about:
The impact of the availability of lighting was so great that even children’s test scores were improved. “When I first started teaching here five years ago, most of the children couldn’t even write their names properly, and they would fail their tests even with only 50%-60% required for passing,” stated the village school teacher. “It took me one and a half years to just get them to memorize the prayer we do in the morning before starting school.” According to some accounts, the extended hours of study provided by the lighting systems has led to a 70% improvement in retention of knowledge, and, on average, students in Dabkan are studying one to three hours longer than they did before. The introduction of solar energy into an energy-starved community is not a mere convenience but can contribute to improved literacy rates and workforce skills for a new economy in geographies otherwise dominated by agriculture.
American citizens take for granted the ability to 'flip a switch' to draw light from any number of sources. The excerpt above brings up the following questions regarding funding agencies in the United States:
What happens if the government chose not to invest in energy or other federal agencies highlighted in the above paragraphs? What happens if we did not have research into cures for diseases? What happens if we did not invest in research for clean water?
I think that you get the point that investment in research agencies is an investment in your well-being!
Conclusion...
The agencies introduced above contain a vast resource of our tax-payer money. Money that was spent to advance the health of the planet and its inhabitants. Additionally, the funds push the boundary of science to produce technology which was unthinkable just decades ago. A super computer in the sixties is not too far off from the tablet which you hold in your hand today. The emergence of exciting fields such as nanotechnology which is beginning to offer cures (for diseases) and device miniaturization continues to astound the world with its realization. The momentum of science funding needs support from you and I --- everybody.
As I mentioned above, the available content on various agencies sites (FDA, EPA, NIH, etc) affects the well-being of each of us. Science impacts every aspect of the world around us -- whether we choose to believe this fact or not. We must continually try to hold politicians accountable when the facts are on the wall in support of science. Additionally, we must not let politicians restrict our access to the content that has been paid for by our hard earned dollars. We fund the science, we own the results.
In closing, I was reading an editorial from the journal 'Nature' titled "Stand Up For Science" recently and the closing of the article was pertinent to the conclusion of this blog post. Therefore, I will end with the excerpt from the article shown below:
Although the Trump team reportedly repudiated its own request for the DOE list, scientists must be wary in the years to come of attempts to prevent scientific information from reaching the press and the US public. We have seen such attempts before, during the George W. Bush administration. They will not necessarily be obvious; as in Canada, they may come in the form of draconian procedures that delay communication with the press for so long that such communication becomes worthless. Or they may come in the form of intimidating researchers, as in the recent furor over work that requires fetal tissue.
If the US wants to remain a leader in biomedical research, the incoming government will need to keep funding it (including basic research) over the long term. And in all fields, scientists must be able to speak freely about their work if science is to be vigorous, the public informed, and policy decisions based on knowledge rather than ideology. The scientific community is watching and waiting.
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.
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.
Of the many unanswered questions that exist around the current election cycle, very few are as important than questions surrounding current scientific research and the funding for the future.
Why should the public vote/influence an increase in science funding?
Why do I suggest the importance of such research is so high?
The range of issues that are tied to science funding is enormous. Most people do not realize what issues are encompassed by science funding. If you (the reader) are one that ties research funding only to important issues like - space or defense - then I ask you to please read everything below. The reason is that the range of issues affected by science include climate science (flooding from Hurricane Matthew) to research into better treatments for eradicating the Zika Virus or Ebola Virus.
Additionally, what about the homeless problem that plagues the United States which includes many victims to serious mental health issues and impact the veterans among others roaming the streets without help. Before you go to the voting polls tomorrow, please read the information below which might or might not influence your vote. Either way, after reading the blog post below, you will definitely be better informed. Last but not least, I will provide direct evidence of the wonderful job that artists such as Beyonce, Jay Z, and Leonardo DiCaprio are doing to elevate science and the need to get out and vote -- which is super inspirational.
Note: various words or phrases are hyperlinked to earlier posts on the subject or other research articles. Please read widely and inform yourself on Science Issues.
Pending Issues Which Need To Be Addressed
Just look at the current state of affairs around the nation and the world along with the issues raised in the blog post below. Then we can talk about the importance of such issues. Currently, the entire East Coast of the United States is recovering from the dramatic flooding and winds which struck when Hurricane Matthew swept through and wreaked havoc on the region.
Any discussion of the funding for the destruction and the recovery?
Has the East Coast rebuilt all of the damaged structures?
Not in the least. Why not? If the same lack of attention toward science research into the issues exist today, where will we be as a nation in 4 or 8 years? This is why the issues of science are serious and need to be entertained before we head to the voting polls next week. At this point, you might be wondering the following question:
What are the most critical issues at hand that are associated with science for the candidates to express their views toward?
A recent article from the website "BioscienceTechnology" titled "Coalition Presses US Presidential Candidates to Address Science Issues" offered commentary on the "Top 20 Questions" from the nonprofit organization "ScienceDebate." The author chose to offer up six of the 20 questions as necessary to provide an example. The six sample questions are shown below:
1) Many scientific advances require long-term investment to fund research over a period of longer than the two, four, or six year terms that govern political cycles. In the current climate of budgetary constraints, what are your science and engineering research priorities and how will you balance short-term versus long-term funding?
2) Mental illness is among the most painful and stigmatized diseases, and the National Institute of Mental Health estimates it costs America more than $300 billion per year. What will you do to reduce the human and economic costs of mental illness?
3) Strategic management of the US energy portfolio can have powerful economic, environmental and foreign policy impacts. How do you see the energy landscape evolving over the next 4 to 8 years, and, as President, what will your energy strategy be?
4) Public health efforts like smoking cessation, drunk driving laws, vaccination, and water fluoridation have improved health and productivity and save millions of lives. How would you improve federal research and our public health system to better protect Americans from emerging diseases and other public health threats, such as antibiotic resistant superbugs?
5) Science is essential to many of the laws and policies that keep Americans safe and secure. How would science inform your administration’s decisions to add, modify, or remove federal regulations, and how would you encourage a thriving business sector while protecting Americans vulnerable to public health and environmental threats?
6) Evidence from science is the surest basis for fair and just public policy, but that is predicated on the integrity of the evidence and of the scientific process used to produce it, which must be both transparent and free from political bias and pressure. How will you foster a culture of scientific transparency and accountability in government, while protecting scientists and federal agencies from political interference in their work?
The author seem to want to suggest that the above issues just did not impact science funding, but were of significance to the public at large. I found the paragraph below fascinating:
“Some politicians think science issues are limited to simply things like the budget for NASA or NIH, and they fail to realize that a President’s attitude toward and decisions about science and research affect the public wellbeing, from the growth of our economy, to education, to public health,” Rush Hold, CEO of the American Association for the Advancement of Science, said in a prepared statement. He said that Americans should have the opportunity to know where Presidential candidates stand on these issues.
All issues that are researched from a scientific standpoint are important. Just because the public does not see the ramifications of such research does not disqualify funding. Of course, there are certain areas that are of immediate importance than others.
Science Lessons For Next President
According to a recent article in the Journal "Science" titled "Science lessons for the next president" there are certain issues that need definite support. Here is a short video of the issues stated succinctly (less than 4 minutes in length):
Below are the critical science lessons that are of upmost importance for the next President:
1) "Pathogens Change Faster Than Our Defenses"
Our ability to stay ahead of deadly pathogens relies on our ability to understand how to dismantle a virus or deadly bacteria. I wrote a blog about new research that recently was uncovered in which scientists discovered a site (a part of the molecule) that is responsible for disabling the effectiveness of the antibiotic. Meaning, if a target molecule hits this site, then the antibiotic is rendered ineffective (useless) and will not work.
More money should be devoted toward understanding and developing ways to counter that pathway toward disabling the antibiotic -- which is commonly termed as "Antibiotic Resistance." Additionally, this relies on funding to develop drugs that will be effective and can be tuned to treat evolving pathogens. In a blog post that I wrote recently, there was a short video outlining with an explanation the drug development process which is worth looking at and reading. If you are still not convinced after reading the blogs, then read below the excerpt from the Journal 'Science' on critical issues which offers an alternative explanation of the importance of such research:
Importance:
Why it matters: Evolving pathogens can threaten our food and water supplies, natural resources, and health. In the United States, 2 million people develop antibiotic-resistant infections each year, and 23,000 die. Globally, the World Health Organization estimates that in 2015 there were 580,000 new cases of tuberculosis resistant to the two most powerful drugs used against this disease. Increasing drug resistance in malaria, HIV, and other major diseases threatens to undermine control efforts. And recently emerged threats, such as the Zika and Ebola viruses, are certain to evolve in ways that can be hard to predict. To develop treatments, scientists often must work with the most dangerous pathogens in laboratories, and sometimes even engineer new strains; this creates the possibility of accidental or intentional releases that could have dire consequences.
With the emergence of stories surrounding the spread of diseases throughout the world, research into these diseases is critical. The issues above are due to evolving chemical systems that are natural and are constantly challenging us to keep ahead of the game to fight new pathogens. If we switch gears and look at issues that are brought on by our own actions, we find challenges that definitely need to be addressed immediately. One such issue is 'genetic engineering.' The question is raised below:
What about potential problems brought by our own actions?
2) "CRISPR Raises Tough Ethical Issues"
Recently, the field of 'genetic modification' has been getting alot of attention and rightly so. The prospect of changing an organisms "genetic code" seems strange and straight out of a science fiction book. Although, if I were to tell you that certain foods you eat have been genetically modified and you still love them -- what would you do? Furthermore, if the so called 'genetic modification' was to help the crop avoid destruction -- i.e., preserve a given crop in order to provide you food, would your opinion change? The current benchmark (among other methods) is the rising CRISPR-Cas9 method. You can read more about the method on the 'Wikipedia' page if you wish. In order to understand the importance of funding such research along with the potential implications, lets turn to the same article from the Journal 'Science' with the following explanation shown below:
Importance:
Why it matters: A powerful tool for basic research, CRISPR could also lead to new treatments for genetic disease in humans, pest-resistant crops with higher yields, and disease-resistant livestock. But uses of CRISPR could also raise profound ethical and regulatory concerns. It could allow the creation of human embryos with modified genes in their germ line—eggs and sperm—meaning the changes would be passed on to future generations. And, in an approach known as gene drive, CRISPR could be used to permanently alter the genome of an entire species in ways that could shift its evolutionary path and ecological role, or even wipe it off Earth. In principle, gene drive could give an endangered species a boost, wreck the genetic defenses that allow some weeds to resist herbicides, or drive a disease-carrying mosquito to extinction.
The promises are huge as well as the payoffs if the CRISPR method is perfected. And I say "perfected" -- why? Because, according to a certain part of the science community, the method does not work "perfectly." Professor Karmella Haynes at Arizona State University is performing research that investigates which environments where the CRISPR method works well. The method does not work well in human embryo cells. The DNA is coiled differently (slightly as a defense mechanism) which presents a large challenge. Of course, in the popular science news, positive results are published rather than discouraging results. Nonetheless, the method is still a strong method.
As an example, here is a short video of a reporter trying to perform the CRISPR method and failing shown below:
The above video shows the extent to which science is a profession of tireless effort. Time is put into get results and verify the methodology of a given experiment. Often, people think that scientists have an easy job -- but in fact, the development of research that is reproducible and clear to the public is a difficult task which takes time and money.
Certain areas require more time than others to delve into a given research inquiry. How about the atmosphere? The time scale of global warming is seemingly long. Although, according to current reports, action is needed immediately. The danger associated with the lack of immediate action is catastrophic. I find the fact that certain politicians are in denial a terrible observation and can only exacerbate the problem and solution.
3) "Sea Levels Rising"
As a nation, the United States public has been engulfed by the current chatter on the television along with the myriad devices that each of us carry around. Not too long ago, their were three presidential debates. Did you watch the debates? Were you able to watch the debates? Why do I ask such questions?
Because, while some were watching the debates, other East Coast residents were in the midst of cleaning up their lives which were ripped apart by Hurricane Matthew. The depth of the destruction along with the cost of the damage to the U.S. has not yet been realized. What is realized is that there have been some crazy weather patterns lately. Further, the seas have been rising. Both situations are not good indicators for the future. The amount of rain that dropped during Hurricane Matthew was insane compared to other large storms around the globe. You can read about the comparison here.
In order to fully understand the importance of such rising sea levels, lets turn to the article (series) we have been citing about the six lessons for the next president. Here is the "importance" stated below:
Importance:
Why it matters: Nearly 40% of the U.S. population lives near the coast, and shorelines host extensive infrastructure—including roads, rail lines, ports, military bases, and energy, water, and sewer plants—that will cost billions of dollars to protect or replace. Already, shorefront communities in hot spots of sea level rise, such as Hampton Roads, Virginia, and Miami Beach, Florida, are seeing tidal floods—even on sunny days—that clog traffic, poison lawns, and corrode utilities. Key ecosystems are also at risk of inundation, such as wetlands and aquatic grass beds that help protect coastlines from storms and provide important nursery grounds for economically important fish. This rising stage also allows stormwaters to surge deeper and higher inland, exacerbating their damage.
Based on the destruction that we have seen this year in the United States as a result of a rising sea level (flooding rain), there is no question that the above research is vitally important. One candidate (Donald Trump) would like to take funds away from research concerning global warming and fight ISIS. Ask yourself if this is a good idea? Is that where you want your money spent? Money is already available for the Department of Defense for such adventures. If any money should be diverted toward research in defense, then how about toward mental health for veterans returning from war with invisible wounds?
4) "Brain Health Should Be Top Of Mind"
Dr. James Watson once posed the following question regarding the human brain:
Can the brain understand itself?
The above question at first sight appears to be quite simple. Yet, over the decades that have past coupled with the advancing digital age, science still appears to be in the dark age to an extent. At the other end of this logic, the computational power needed to understand the brain is said to not yet exist. If the second statement is correct, then we need not stop funding research just yet.
Each and every one of us has either experienced or been touched by a person with a mental health issue. Even if we did not realize it at the time. Mental health is an extremely complicated issue that plagues parts of the entire population from the homeless to the ultra rich. Mental Illness is blind to income and wealth. With the new initiative to study the brain put forth by President Obama, we are headed in the correct direction. He has the BRAIN initiative - which can be understood in greater detail by reading more about here. Why is the health of the brain so important? Here is an excerpt from the article in 'Science' below:
Importance:
Why it matters: Brain health touches us from cradle to grave, and when brain disease strikes, the costs—personal and budgetary—are staggering. By 2025, at least 7 million Americans are expected to suffer from Alzheimer's disease, which causes memory loss, personality changes, impaired reasoning, and, eventually, death. This year alone, treating and caring for Americans with Alzheimer's and other less common dementias cost $236 billion, with government health programs shouldering two-thirds of the cost. At the other end of life, the prevalence of autism, a disorder of language and social communication, rose by 123% between 2002 and 2012. That year, one in 68 U.S. children was affected; costs to each affected family are estimated at about $60,000 annually.
Other brain health issues abound. Learning disabilities are a big issue in classrooms; mental illness is common in the homeless, in addicts, and in prison inmates; and concussions have become a major concern in sports. The military faces the burden of treating traumatic brain injuries and the psychological aftereffects of combat. Effective diagnostics and treatments could make a huge difference.
As I mentioned above, the amount of computational power needed to fully understand the brain is just being realized. Think about current research just published which shed light on the way proteins behave in their natural environment -- inside a human cell. If research carried out at the current level sheds light on the onset of diseases, then imagine the requirement to understand diseases inside the entire brain (different parts of the brain acting together). The point is that research into the disease causing aspects of the brain as well as our ability to comprehend the world around us is extremely important.
With the rise of the machine in understanding the world around us come other advances of the same technology. Artificial intelligence has been speculated to be around and supposedly proposed to play a large role in our lives in the coming decades. For now, what about simple machines -- drones? self driving cars, etc?
5) "Machines Are Getting Much, Much Smarter"
Elon Musk has been in the news lately for a variety of reasons. His space initiative has cost the private sector of the space industry a pretty penny. He has shown a complete lack of regard for the loss of life in his Tesla cars while operating on autopilot. How? He cannot admit that his technology is not nearly where technology needs to be at in order to let everyone have an autonomous car. I write about this here. In order to have completely autonomous cars, advancements in artificial intelligence will have to be taken toward a whole new level. Currently, we are not there yet. Science can shed light on potential issues that prevent us from proceeding to 'go' just yet -- which are shown below:
Importance:
Why it matters: Although experts say we are still decades away from machines that truly think like humans, narrower applications of AI are already having an impact on society. Products and services from self-driving cars to systems that guide medical care and treatment could bring major benefits, including increased labor productivity, lucrative new markets, and fewer deaths from traffic accidents and medical mistakes. But AI brings worries, too. It will enable employers to automate more tasks and displace workers, and economists predict that some low-wage jobs will be among the first to be eliminated, possibly increasing economic inequality. Letting machines make their own decisions also raises profound ethical, legal, and regulatory questions. Who is responsible if an autonomous car crashes, a piece of software wrecks an investment portfolio, or a sensor switches a stoplight to green at the wrong time? The stakes are even higher on the battlefield, where the military is exploring the possibility of fielding autonomous lethal weapons that would make their own decisions about when to fire.
Advancing forward, a fair amount of research needs to be conducted. From the machine programming and execution standpoint, current research is quite advanced. Just this week, research about a world record was set for NASA surrounding the precision of a satellite with GPS technology. A satellite traveling at a distance of 43,500 miles travels the slowest, whereas at a distance of just under 5 miles from Planet Earth -- the satellite can travel at speeds of 22,000 miles per hour. The precision offered in orbit has allowed very precise 3-dimensional images of different aspects of Earth. This is just one of many reasons why space funding is extremely important. Better precision, better time, new technologies.
Although, with space research comes risk. Over the decades, risk has been studied and worked on by scientists over various scales within various problems. From the small scale - quantum error correction to the enormous scale of space flight - risk remains a crucial area of need to study in greater detail.
6) "We Aren't So Great At Assessing Risk"
Communicating risk to the public without posing great fear is extremely complicated. In many areas of research, communication of results is equated with great fear surrounding the research which leads to reductions in funding and possible cancellations of investigations all together. This highlights the demand to understand how to greater understand risk and the ability to convey risk to the greater public. Two areas seem to be polarized with regard to risk: 'genetic engineering' and 'climate change'. These two areas stand at opposite ends of the spectrum, but are equally important. In the area of 'genetic engineering' - the scare lies in the unknown product and effect toward civilization. Whereas in the other area -- climate science, the scare lies in the incomprehensible. Thinking on the global scale couple with temperatures rising to the point of civilization not being able to occupy the Earth is unfathomable and science fiction -- as far as some are concerned.
Therefore, understanding how to communicate and assess risk is crucial. Science says:
Importance:
Why it matters: Misperception of risk can push a president to overreact to lesser threats and underreact to greater problems, or to embrace policies that may make people feel good but end up being costly and ineffective—or even counterproductive. And how a president communicates with the public about risk can mean the difference between sowing panic and maintaining calm. Talking realistically about risks in advance—as opposed to promising absolute protection—may help prepare people for the inevitable disasters and minimize calls for a policy response that's out of proportion to the actual threat. To do this effectively, the president will have to maintain the public's trust, which is much harder to earn than it is to lose. Understanding the basic psychology of risk can help avoid missteps.
Again, transmitting the unfathomable to the public is complicated. The best hope is that the communicator is a good communicator (patient, humble, and intelligent) with a great audience (patient, humble, and intelligent). Yes, each of us need to do our part to achieve transmission of information (i.e. communication) between one another. Hollywood does this quite well. Science is a work in progress.
Celebrities Elevate STEM and Voting!
Beyonce (the singer) recently promoted the presidential candidate Hillary Clinton along with her husband Jay Z. With good reason. It has taken over a hundred years to achieve equality (and we are still fighting for it) - a work in progress. Having the first female president would be a major step in the right direction. Furthermore, this would reinforce the idea that any woman can go as far as she is willing to work to go. My wife is a scientist and I encourage her to be the best she can be -- break all barriers.
Although, the fields -- Science Technology, Engineering, and Mathematics (STEM) still need more women and minorities engaging in them for careers. Each of us is smart in our own unique way. There are plenty of women and minorities out there to help take science and society to the next advanced level. Having celebrities elevate science is critical. Science usually gets a bad rap. Why? Movie portrayals (such as "The Accountant") portray scientists as strange with disorders but super smart. Not all are strange. I promise.
Recently, the actor Leonardo DiCaprio became the 'Messenger of Peace' for the United Nations -- an honor he holds dearly and sincerely. He speaks about the role in a documentary he recently released investigating the state of global warming and explored all possible solutions. We need more people like him with the unparalleled ability to communicate to a large audience the importance of research and world problems. Here is the video below (just over an hour and a half in length) - but worth watching before or after the election:
I think that I have provided you (the reader) with an eyeball full of information to think about before you hit the voting polls. Get out and vote. Listen to the stars, listen to your family, just be sure to vote. Exercise your place in our democratic society. Yes, your vote does count.
Conclusion ...
Science funding impacts all areas of our lives. If you do not believe me, just try to think of an area which has nothing to do with science. Leave the answer in the comments below and I will try to provide a rebuttal to your answer. There is no rebuttal for the issues that can be solved with science but lack funding. We need all of the help that is possible to educate the public about the importance of science. How do you help?
The most important learning begins at home. What about science do you not understand? Why don't you care? What kind of world are you leaving to your children? These questions do have answers. The unknown is centered around how those answers will surface in the days and years to come. Whether we find out the answers through your vote, your children, your family, the answers will become apparent. Why not educate yourself and others on critical issues for a better society?
I hope that each of you go out and vote tomorrow. Further, I hope that each of you are inspired to educate yourself more after reading this post. Until next time, Have a great day!!!
