bellionluther

bellionluther

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Bellion LutherHarvard University

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On July 4, 1776, when the Continental Congress adopted the historic text drafted by Thomas Jefferson, they did not intend it to mean individual equality. Rather, what they declared was that American colonists, as a people, had the same rights to self-government as other nations. Because they possessed this fundamental right, Rakove said, they could establish new governments within each of the states and collectively assume their

"separate and equal station" with other nations. It was only in the decades after the American Revolutionary War that the phrase acquired its compelling reputation as a statement of individual equality.

Here, Rakove reflects on this history and how now, in a time of heightened scrutiny of the country's founders and the legacy of slavery and racial injustices they perpetuated, Americans can better understand the limitations and failings of their past governments.

Rakove is the William Robertson Coe Professor of History and American Studies and professor of political science, emeritus, in the School of Humanities and Sciences. His book, Original Meanings: Politics and Ideas in the Making of the Constitution (1996), won the Pulitzer Prize in History. His new book, Beyond Belief, Beyond Conscience: The Radical Significance of the Free Exercise of Religion will be published next month.

I view the Declaration as a point of departure and a promise, and the Constitution as a set of commitments that had lasting consequences - some troubling, others transformative. The Declaration, in its remarkable concision, gives us self-evident truths that form the premises of the right to revolution and the capacity to create new governments resting on popular consent. The original Constitution, by contrast, involved a set of political commitments that recognized the legal status of slavery within the states and made the federal government partially responsible for upholding "the peculiar institution."

As my late colleague Don Fehrenbacher argued, the Constitution was deeply implicated in establishing "a slaveholders' republic" that protected slavery in complex ways down to 1861.

But the Reconstruction amendments of 1865-1870 marked a second constitutional founding that rested on other premises. Together they made a broader definition of equality part of the constitutional order, and they gave the national government an effective basis for challenging racial inequalities within the states. It sadly took far too long for the Second Reconstruction of the 1960s to implement that commitment, but when it did, it was a fulfillment of the original vision of the 1860s.

With the U.S. confronting its history of systemic racism, are there any problems that Americans are reckoning with today that can be traced back to the Declaration of Independence and the U.S. Constitution?

Answer: Yes, there are many problems that Americans are reckoning with today t...

Two things. First, the toughest question we face in thinking about the nation's founding pivots on whether the slaveholding South should have been part of it or not. If you think it should have been, it is difficult to imagine how the framers of the Constitution could have attained that end without making some set of "compromises" accepting the legal existence of slavery. When we discuss the Constitutional Convention, we often praise the compromise giving each state an equal vote in the Senate and condemn the Three Fifths Clause allowing the southern states to count their slaves for purposes of political representation. But where the quarrel between large and small states had nothing to do with the lasting interests of citizens - you never vote on the basis of the size of the state in which you live - slavery was a real and persisting interest that one had to accommodate for the Union to survive.

Second, the greatest tragedy of American constitutional history was not the failure of the framers to eliminate slavery in 1787. That option was simply not available to them. The real tragedy was the failure of Reconstruction and the ensuing emergence of Jim Crow segregation in the late 19th century that took many decades to overturn. That was the great constitutional opportunity that Americans failed to grasp, perhaps because four years of Civil War and a decade of the military occupation of the South simply exhausted Northern public opinion. Even now, if you look at issues of voter suppression, we are still wrestling with its consequences.

You argue that in the decades after the Declaration of Independence, Americans began understanding the Declaration of Independence's affirmation that "all men are created equal" in a different way than the framers intended. How did the founding fathers view equality? And how did these diverging interpretations emerge?

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After reading answer briefly answer the 3 questions. 

One of the oldest medications still used often in clinical practice is heparin. It was founded in 1916 before the Food and Drug Administration was created. Generated nearly solely from pigs' mucosal tissues. (Hedlund, 2013) The market for heparin depends on China because of its sizable swine herds. The drug's supply chain starts at slaughterhouses, then moves on to tiny workshops that collect heparin crude by removing the mucous membranes from pig intestines. Then, after being further refined into an active pharmaceutical component, the crude heparin is sold to other facilities, often via consolidators (API). In order to generate a completed heparin product, such as an injectable pharmaceutical vial, this API is then mixed with inactive components (typically a sterile solution). (Heparin: A Wake-Up Call on Risks to the U.S. Drug Supply, 2012)

The drug heparin was recalled on a global scale in 2008. Numerous fatalities and adverse events were found to be caused by a contaminate identified as oversulfated chondroitin sulphate, according to researchers. (Hedlund, 2013) 81 individuals died as a result of it.  Eventually, it was discovered what triggered the undesirable effect that resulted in the fatalities and injuries. The contaminated chemical was an over-sulfated derivative of chondroitin sulfate, a similarly comparable compound derived from animal or fish cartilage and frequently used as an arthritis therapy. Since over-sulphated chondroitin is not a naturally occurring molecule, it is not as expensive as actual heparin starting material, and it matches the in-vitro characteristics of heparin, the fake was very definitely made intentionally rather than by mistake during production. The contamination was caused by a combination of a lack of appropriate pigs in China and cost-effectiveness, also it was discovered that the raw heparin batches had been reduced by 2 to 60% with the fake chemical. (Chinese Heparin Manufacturer Again Involved in Falsification and GMP Non-Compliance - ECA Academy, 2016)

Following the adulteration, investigations revealed that OSCS was present in both the finished heparin API produced by SPL-CZ and the raw material sent to the firm by Chinese contractors. The specific source or suppliers of the heparin adulteration are still unknown to Baxter and the FDA; however, evidence shows that OSCS was most certainly introduced by organizations upstream of the Chinese API production facility, Scientific Protein Laboratories-Changzhou (SPL-CZ). Starting in 1996, Chinese raw materials have been used to make Baxter's heparin API; SPL-CZ joined the company's heparin production process in 2004. (Heparin: A Wake-Up Call on Risks to the U.S. Drug Supply, 2012)

The U.S. Centers for Disease Control and Prevention (CDC) started looking into an epidemic of unanticipated allergic-type responses in dialysis patients in early 2008, which started in 2007. The majority of them had received heparin intravenously from Baxter Healthcare. Additional analysis found that oversulfated chondroitin sulphate (OSCS), an artificial adulterant with hazardous effects, had been added during the production of heparin in China. Given its close resemblance to the original medication, routine testing was unable to identify OSCS, which is produced for roughly a hundred times less than heparin. (Heparin: A Wake-Up Call on Risks to the U.S. Drug Supply, 2012)A number of Americans experienced negative effects, including fatalities. At least 11 medication items and 72 healthcare products containing heparin were recalled by 14 additional American companies, including Baxter Healthcare, the main heparin producer in the United States. Heparin items were already suspended in Australia, Switzerland, Sweden, Denmark, Germany, France, and Italy as per regional health organisations and press sources. (Heparin: A Wake-Up Call on Risks to the U.S. Drug Supply, 2012)

The heparin scandal exposed a variety of supervision and supply chain management mistakes. Despite not doing a pre-approval examination, the FDA accepted SPL-CZ as a source for Baxter, in part because it mistook SPL-CZ for another website in its database. Investigators from Baxter were not allowed entry to upstream factories and aggregators in 2008 when they attempted to retroactively review their supply chain. (Heparin: A Wake-Up Call on Risks to the U.S. Drug Supply, 2012) Two heparin upstream consolidators were likewise off-limits to the FDA. Baxter started receiving heparin API produced by SPL-CZ in 2004, but somehow it didn't verify the facility until 2007; instead, it relied on an earlier evaluation by a separate business. A variety of production quality concerns were discovered during the investigation of SPL-CZ after the FDA discovered that it had been adulterated, including inadequate quality control procedures for incoming raw materials. SPL-CZ was not licensed by the Chinese State Food and Drug Administration since it was considered a chemical facility in China. It therefore probably received no supervision from the Chinese government. (Heparin: A Wake-Up Call on Risks to the U.S. Drug Supply, 2012)

Questions:

  1. To avoid another situation like heparin adulteration in the future what steps should be taken by the government to protect people?
  2. What could have been the major reason behind heparin adulteration? 
  3. Do you think heparin contamination was intentional? Why or why not?

sources: 

  1. Chinese Heparin Manufacturer again involved in Falsification and GMP Non-Compliance. (2016, march 2). Retrieved from gmp compilance:  [Accessed on: 2023 February 5]

 

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