<blockquote>
<h3>After months of NIH objecting, and after seeking Court intervention, ICAN’s attorneys have won a motion which now forces the NIH to unredact and disclose safety-related data they tried to withhold from Moderna’s Phase 1 clinical trial report.</h3>
</blockquote>
As a result of a Freedom of Information Act (FOIA) request, the National Institutes of Health (NIH) provided the Informed Consent Action Network (<a href="https://www.icandecide.org/">ICAN</a>) a copy of an internal 322-page Safety Summary Report along with over 700 pages of Appendices to that report, detailing safety data from Moderna’s Phase I clinical trial for its and NIAID’s COVID-19 vaccine.  This report was previously shared with ICAN supporters and was the first and only time we are aware of that this report was made public.  It can be downloaded <a href="https://www.icandecide.org/wp-content/uploads/2020/11/Moderna-Combined-Production.pdf">here</a>.

After reviewing the report, <a href="https://www.icandecide.org/wp-content/uploads/2021/07/021-Plaintiffs-Opposition-to-and-Cross-Motion-for-Summary-Judgment-as-to-Request-54464.pdf">ICAN</a> <a href="https://www.icandecide.org/wp-content/uploads/2021/07/028-REPLY-to-response-to-Motion-re-Cross-Motion.pdf">challenged</a> the redactions made within the document, explaining their importance to the public.  NIH <a href="https://www.icandecide.org/wp-content/uploads/2021/07/018-DEFENDANTS-MOTION-FOR-SUMMARY-JUDGMENT.pdf">fought</a> <a href="https://www.icandecide.org/wp-content/uploads/2021/07/026-RESPONSE-to-Motion-ree-Cross-MOTION-for-Summary-Judgment.pdf">back</a> but the Court, in its June 24, 2021 <a href="https://www.icandecide.org/wp-content/uploads/2021/07/035-Order.pdf">decision</a>, ultimately ruled in ICAN’s and the public’s favor holding that the “NIH cannot articulate a sufficient privacy interest to justify redacting” the information that it did and that “the public interest in seeing the full data outweighs any individual privacy concerns” of the clinical trial participants.  "The unredacted data will be provided within a few days and ICAN will immediately make it available so that everyone can see what information is being withheld from the public," ICAN said.

ICAN also challenged the adequacy of the agency’s search and believes there are likely more responsive documents in NIH’s possession.  To address this issue, ICAN has now filed additional FOIA requests to obtain copies of these documents, and any new productions will be shared.  "ICAN will never rest in its fight to expose the truth regarding these products or in demanding full transparency and full informed consent for any and all vaccines, especially as these manufacturers seek FDA licensure for these experimental COVID-19 vaccines," a spokesman added.

[embed]https://twitter.com/SelaReport/status/1417825015689527299[/embed]

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Federal court orders NIH to unredact and disclose safety-related data from Moderna Phase 1 COVID vaccine trial report

Joe Biden called Prime Minister Benjamin Netanyahu immediately after Iran <a href="https://www.timesofisrael.com/idf-shows-remains-of-iranian-ballistic-missile-that-fell-in-dead-sea/" target="_blank" rel="noopener noreferrer">fired</a> "500 ballistic and cruise missiles as well as attack drones” at Israel to “<a href="https://www.timesofisrael.com/liveblog_entry/netanyahu-called-off-retaliatory-strike-on-iran-after-call-with-biden-new-york-times/" target="_blank" rel="noopener noreferrer">dissuade</a>" him from ”greenlighting an immediate retaliatory strike.”<h1>Let the Ayatollah be</h1>Axios provided more <a href=" https://www.axios.com/2024/04/14/biden-netanyahu-iran-israel-us-wont-support" target="_blank" rel="noopener noreferrer">details</a> on the White House pressure on Israel to drop pre-approved plans for retaliation:<blockquote>"You got a win. Take the win," Biden told Netanyahu, according to the official.&nbsp;The official said that when Biden told Netanyahu that the U.S. will not participate in any offensive operations against Iran and will not support such operations, Netanyahu said he understood.</blockquote>The Times of Israel <a href="https://www.timesofisrael.com/pm-shelved-pre-approved-plans-for-immediate-iran-reprisal-after-biden-call-report/" target="_blank" rel="noopener noreferrer">reported</a> that plans for retaliation were pre-approved before the Biden call:<blockquote>Netanyahu shelved plans that had been prepared for retaliation against Iran’s weekend barrage after speaking with US President Joe Biden immediately following the attack…… the cabinet had already approved a series of possible responses depending on the scope of the Iranian attack, which were slated to be carried out immediately following the Iranian fusillade early Sunday.“The response won’t be what was planned any longer; diplomatic sensitivities won out,” a senior source was quoted as telling the broadcaster…The report noted the comments likely pointed to a weaker response than what had been approved. [Emphasis added.]</blockquote>That “weaker response” turned out to be, thus far, just <a href="https://abcnews.go.com/International/live-updates/israel-gaza-hamas-war/no-damage-to-irans-nuclear-sites-after-israeli-strike-iaea-109413374?id=108860743" target="_blank" rel="noopener noreferrer">three missiles</a> aimed at an air defense system in Iran <a href="https://news.yahoo.com/israel-strike-iran-limited-attack-143042469.html" target="_blank" rel="noopener noreferrer">after</a> “the Pentagon urged what amounted to what one senior U.S. official called a ‘signal, not a strike,’ with minimal chance of casualties.” [Emphasis added.]<h1>Good news for Khamenei; not for Iranians</h1>Ali Khamenei, the supreme leader of Iran since 1989, certainly welcomed the news, as Iranian dissidents had been hoping to capitalize on a major retaliatory strike by Israel to precipitate mass protests against the longest-serving head of state in the Middle East. This after already being disappointed by a lack of support from Biden during protests in 2022 that “raged across Iran despite the brutality of the government’s response,” according to <a href="https://www.theguardian.com/commentisfree/2022/nov/29/iran-protests-us-media-coverage-mahsa-amini" target="_blank" rel="noopener noreferrer">The Guardian</a>, which detailed that brutality:<blockquote>Over 400 people have been killed; an unknown number of journalists and demonstrators have been imprisoned or disappeared. Hundreds have been blinded by rubber bullets and metal pellets fired into crowds of protesters. [Emphasis added.]</blockquote><h4>Media in lockstep</h4>Biden's lack of support for the protestors against their despotic leaders led The Guardian to title their article, "Why are Americans ignoring the protests in Iran?" The article noted that, in addition to Biden's muted response, comprising but a short, ambiguous mention within his September 2022 UN speech mostly devoted to Ukrainians, mainstream media left Americans in the dark about the protests.<blockquote>Coverage of the uprising has been notably sporadic; we search our screens and front pages, mostly in vain.</blockquote>Even in the absence of mass protests, executions in the totalitarian terror state have continued, with Amnesty International <a href="https://amnesty.ca/human-rights-news/iran-executes-853-people-in-eight-year-high/" target="_blank" rel="noopener noreferrer">reporting</a>&nbsp;<s> </s>in 2023 that, “Iran executes 853 people in eight-year high amid relentless repression and renewed ‘war on drugs.’” &nbsp;<h2>Iranian hope</h2>Despite prior letdowns, many Iranians hoped that foreign powers would finally intervene to provide protests a chance at success this time around, even taking the risk of publicizing their hopes:<div class="raw-html-embed"><blockquote class="twitter-tweet">Graffiti on a wall in Iran reads: Hit them, Israel Iranians are behind you <a href="https://t.co/JcW7ZPqSas">pic.twitter.com/JcW7ZPqSas</a>— 南洋辉叔 Uncle Hui (@alexcmhwee) <a href="https://twitter.com/alexcmhwee/status/1779845454655897802?ref_src=twsrc%5Etfw">April 15, 2024</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script> </div>One Iranian even pleaded with Israel to directly attack Khamenei:<div class="raw-html-embed"><blockquote class="twitter-tweet">Graffiti in Tehran: “Israel, strike the supreme leader's [Ayatollah Ali Khamenei] house!” <a href="https://t.co/uQ7D7nN8vP">pic.twitter.com/uQ7D7nN8vP</a>— Adam Albilya - אדם אלביליה (@AdamAlbilya) <a href="https://twitter.com/AdamAlbilya/status/1781342418689835072?ref_src=twsrc%5Etfw">April 19, 2024</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script> </div>Support for Israeli attacks on Iran's dictators by America, the leader of the free world, would have particularly provided wind to the sails of Iranian dissidents.&nbsp;CarterThe State Department's failure to fully back dissidents in Iran is particularly noteworthy in light of the role of previous administrations in each of the revolutions that brought totalitarian leaders to power.Prior to the Iranian revolution of 1979, the nation was led by the popular Shah (King) Mohammad Reza Pahlavi.&nbsp;<div class="raw-html-embed"><blockquote class="twitter-tweet">Shah Mohammad Reza Pahlavi and his wife Shahbanu Farah Diba She wears a green dress, a crown, and a diamond necklace set with emeralds. <a href="https://t.co/CKsJ6uZ5L3">pic.twitter.com/CKsJ6uZ5L3</a>— Il lupo Viaggiatore (@E_TaherAlbaghli) <a href="https://twitter.com/E_TaherAlbaghli/status/1599855051761385472?ref_src=twsrc%5Etfw">December 5, 2022</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script> </div>The New American <a href="https://thenewamerican.com/us/culture/history/iran-and-the-shah-what-really-happened/" target="_blank" rel="noopener noreferrer">detailed</a> the lengths to which the Carter administration went to bring down the Shah:<blockquote>The Carter administration’s continuous demand upon the Shah: liberalize. On October 26, 1978, he freed 1,500 prisoners, but increased rioting followed. The Shah commented that “the more I liberalized, the worse the situation in Iran became. Every initiative I took was seen as proof of my own weakness and that of my government.” Revolutionaries equated liberalization with appeasement. “My greatest mistake,” the Shah recalled, “was in listening to the Americans on matters concerning the internal affairs of my kingdom.”Iran’s last hope: its well-trained military could still restore order. The Carter administration realized this. Du Berrier noted: “Air Force General Robert Huyser, deputy commander of U.S. forces in Europe, was sent to pressure Iran’s generals into giving in without a fight.” “Huyser directly threatened the military with a break in diplomatic relations and a cutoff of arms if they moved to support their monarch.”“It was therefore necessary,” the Shah wrote, “to neutralize the Iranian army. It was clearly for this reason that General Huyser had come to Teheran.”</blockquote>The White House did not even try to hide the purpose of sending a top general to Iran during the protests:<blockquote>Huyser only paid the Shah a cursory visit, but had three meetings with Iran’s revolutionary leaders — one lasting 10 hours. Huyser, of course, had no authority to interfere with a foreign nation’s sovereign affairs.Prior to execution later by Khomeini, General Amir Hossein Rabbi, commander-in-chief of the Iranian Air Force, stated: “General Huyser threw the Shah out of the country like a dead mouse.”</blockquote>The Shah finishes the story in his own words:<blockquote>U.S. officials pressed the Shah to leave Iran. He reflected:You cannot imagine the pressure the Americans were putting on me, and in the end it became an order …. How could I stay when the Americans had sent a general, Huyser, to force me out? How could I stand alone against Henry Precht [the State Department Director for Iran] and the entire State Department? [Emphasis added.]</blockquote><h3>&nbsp;</h3><h2>Keep Khamenei for stability?</h2>The White House has justified its calls for almost no retaliation against Iran with claims that strong strikes could widen Israel's war and destabilize the region with the conflict “<a href="https://www.msn.com/en-us/news/world/biden-endeavors-to-prevent-spread-of-conflict-after-iran-attack/ar-BB1lFk8Z" target="_blank" rel="noopener noreferrer">escalating</a>."In fact, Iran has already destabilized the region, using Hamas terrorists in Gaza and the West Bank, Hezbollah terrorists in Lebanon and Syria, and Houthi terrorists in South Yemen to attack Israel on five fronts. The NY Post <a href="https://nypost.com/2024/04/15/world-news/iranian-american-lawyer-blasts-supporters-of-islamic-regime-calling-for-war-with-israel-we-want-peace/" target="_blank" rel="noopener noreferrer">covered</a> Elica Le Bon, a British-born, American-educated lawyer and popular TikToker of Iranian descent, making this very point:<blockquote>Le Bon further argued that far from being the victim, Iran was the aggressor responsible for creating Hamas and Hezbollah, as well&nbsp;as the Houthis in Yemen, for the sole purpose of destabilizing the region. [Emphasis added.]</blockquote>Le Bon emphasized this point to her 300,000 followers:<blockquote>How about the terror proxies that the Islamic Republic has created to foster regional instability … What did you think Hezbollah was there for … , Hamas, Houthis. Their miliita groups in Iraq and Syria.&nbsp;Did you think they were there to instigate a system of public schooling, education, to feed the poor, house the unhoused? … Are the rockets that Hamas fires into Israel on a near daily basis an act of war?</blockquote>She also clarified the difference between the regime and the population they rule:&nbsp;<blockquote>First of all, you're not talking about Iran, you're talking about the Islamic Republic…Iranians don't want war with Israel. We want peace with Israel. Iranian people inside of Iran have come out and said this over and over and over again. It's you [the regime] that wants war with Israel.</blockquote>The NY Post also notes Le Bon's complaint that the regime's oppression of Iranians is ignored by Hamas supporters:<blockquote>“When we were screaming that they were killing Iranian women for not wearing a hijab, where were you?” Le Bon demands to know in the video, which has gone viral with more than 1 million views.“When they were lynching Iranian men from cranes for protesting, where were you? When we were explaining that it’s a terrorist occupying force, where were you?” &nbsp;</blockquote><div class="raw-html-embed"><blockquote class="twitter-tweet">WATCH An Iranian in the UK responds with "BS" to those who claim that "Iran has the right to defend itself." Via <a href="https://twitter.com/elicalebon?ref_src=twsrc%5Etfw">@elicalebon</a> <a href="https://t.co/o90RoF4taw">pic.twitter.com/o90RoF4taw</a>— Open Source Intel (@Osint613) <a href="https://twitter.com/Osint613/status/1779767681471721564?ref_src=twsrc%5Etfw">April 15, 2024</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script> </div><h4>Gazans too</h4>Hamas supporters not only fail to show concern for Iranians oppressed by dictators — they also fail to show concern for those <a href="https://frontline.news/post/globalists-cremate-care-for-gaza-refugees" target="_blank" rel="noopener noreferrer">suffering</a> under tyrannical Hamas terrorists. While <a href="https://cis.org/Bensman/Government-Admission-Biden-Parole-Flights-Create-Security-Vulnerabilities-US-Airports" target="_blank" rel="noopener noreferrer">flying </a>thousands of illegal adult, male migrants into the U.S. from nations at peace, Secretary of State Antony Blinken labeled the relocation of even women and children in Gazan war zones a “<a href="https://twitter.com/TheEconomist/status/1714301727782871512?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed%7Ctwterm%5E1714301727782871512%7Ctwgr%5E76189453f9bc921d7260794b364a8ab4877de088%7Ctwcon%5Es1_&amp;ref_url=https%3A%2F%2Ffrontline.news%2Fpost%2Fglobalists-cremate-care-for-gaza-refugees" target="_blank" rel="noopener noreferrer">non-starter</a>.”<h2>Future Shah?</h2>Crown Prince Reza Pahlavi, the oldest son of the last Shah of Iran and the last heir-apparent to the throne of the Imperial State of Iran, currently in exile in the United States, advocates for Middle East stability through the removal of Iran's leaders and a restored peace with Israel, as he writes on X:<div class="raw-html-embed"><blockquote class="twitter-tweet">For years I have said the fates of Iranians and Israelis are uniquely intertwined. We have common hopes for peace, but are denied it by a common enemy: the Islamic Republic. This regime poses an existential threat to both Iran and Israel that will continue as long as this regime…— Reza Pahlavi (@PahlaviReza) <a href="https://twitter.com/PahlaviReza/status/1779310516273332273?ref_src=twsrc%5Etfw">April 14, 2024</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script> </div>An Iran ruled by Pahlavi would be expected to immediately defund Hamas, Hezbollah and the Houthis and bring stability to the region.See our additional coverage of the Middle East:<ol><li><a href="https://frontline.news/post/hamas-long-term-strategy-revealed">Hamas' long term strategy revealed</a></li><li><a href="https://frontline.news/post/what-was-hamas-thinking">What was Hamas thinking?</a></li><li><a href="https://frontline.news/post/how-to-spot-a-fake-uprising-and-keep-america-out-analysis">How to spot a fake uprising - and keep America out - analysis</a></li><li><a href="https://frontline.news/post/pallywood-palestinian-hollywood-generating-fake-anti-israel-videos">'Pallywood': Palestinian Hollywood generating fake anti-Israel videos</a></li><li><a href="https://frontline.news/post/5-gazans-crushed-by-airdropped-food-packages-as-helicopters-try-to-avoid-hamas-rockets">5 Gazans crushed by airdropped food packages as helicopters try to avoid Hamas rocket</a></li></ol>

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World News

Carter pressed Shah to leave Iran; Biden pressed Israel to leave Khameini regime intact

White House chooses Khamenei over Iranian people, again

Safe and effective strikes againAccording to many studies and surveys, over 15 percent of people in modern America suffer periods of depression at least once a year, and many, if not most, take prescription drugs of some form to deal with their emotions. Since mental health services are often <a href="https://www.cdc.gov/nchs/covid19/pulse/mental-health-care.htm" target="_blank" rel="noopener noreferrer">difficult to access</a>, as well as expensive, unhealthy use of illicit drugs or alcohol is also common among the depressed.Another approach has been <a href="https://www.statnews.com/2024/04/08/time-is-right-for-over-the-counter-antidepressants/?utm_campaign=pharmalot&amp;utm_medium=email&amp;_hsenc=p2ANqtz-8Xs0nnL7hvSJsSA_go0VKTrwg5g1WD-3UaMxPPiHqSzUA4UiDBBMJIHToSFTM7DOIKFJqZ_ZJFA_fEjnCdtfbQ20iS4UFN7OOhieSR9pgHphbjJII&amp;_hsmi=301755960&amp;utm_content=301755960&amp;utm_source=hs_email" target="_blank" rel="noopener noreferrer">proposed </a>by Roy Perlis, a professor of psychiatry at Harvard Medical School and associate chief for research in the Department of Psychiatry at Massachusetts General Hospital in Boston. Noting that oral contraceptives are now available over-the-counter without a prescription, he suggests that the same should apply for the class of anti-depressant drugs known as SSRIs. After all, he claims, they are “safe and effective”:<blockquote>These medications, which have been used in the U.S. for three decades, have repeatedly been shown to be safe and effective for treating major depression and anxiety disorders.</blockquote>&nbsp;Downplaying suicide risk, homicide risk unmentionedAfter making that categorical statement on safety and effectiveness, Perlis admits that “depression is associated with increased risk for suicide and medication overdose is among the most common methods of suicide.” He claims, however, that the increased suicide risk associated with SSRIs only applies to those under the age of 25 and then only “modestly,” and that for those above this age, there is no increased risk.Based on a wealth of data, Professor Peter Gotzsche, one of the founders of the Cochrane Collaboration, concludes that <a href="https://www.madinamerica.com/2024/04/prescription-drugs-are-the-leading-cause-of-death/" target="_blank" rel="noopener noreferrer">SSRIs are far more dangerous</a> than Prof. Perlis asserts. Aside from their links to suicide (and also <a href="https://www.bmj.com/content/358/bmj.j3697/rr-4" target="_blank" rel="noopener noreferrer">homicide</a>) which apply to those over the age of 25 as well, SSRIs are also linked to events that few people would consider as being associated, such as falls in the elderly (which often contribute to death), as anti-depressants cause orthostatic hypertension, confusion, and dizziness. Given that the link is indirect, studies that investigate the dangers of SSRIs will usually miss such risks.SSRIs are also linked to <a href="https://frontline.news/post/study-depression-in-an-expectant-mother-doesn-t-harm-her-baby-anti-depressants-do" target="_blank" rel="noopener noreferrer">dangers</a> for unborn babies, and while this also applies to many OTC drugs making SSRIs so readily available may contribute to a perception that they are safe for pregnant women.Anti-depressants linked to antibiotic resistanceAn interesting <a href="https://pubmed.ncbi.nlm.nih.gov/36689653/" target="_blank" rel="noopener noreferrer">study</a> published in 2023 has also linked use of anti-depressants to antibiotic resistance, a growing and under-publicized problem across the world, providing another reason to restrict access to these drugs. The study's authors note that,<blockquote>Antidepressants are consumed in large quantities, with a similar pharmaceutical market share (4.8%) to antibiotics (5%). While antibiotics are acknowledged as the major driver of increasing antibiotic resistance, little attention is paid to the contribution of antidepressants in this process.</blockquote>&nbsp;Meanwhile, the idea of freely available ketamine sparks alarmNot too long ago, Elon Musk sparked controversy when he spoke about his use of ketamine to treat depression.<div class="raw-html-embed"><blockquote class="twitter-tweet">Depression is overdiagnosed in the US, but for some people it really is a brain chemistry issue. But zombifying people with SSRIs for sure happens way too much. From what I’ve seen with friends, ketamine taken occasionally is a better option.— Elon Musk (@elonmusk) <a href="https://twitter.com/elonmusk/status/1673567124768317440?ref_src=twsrc%5Etfw">June 27, 2023</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>Interestingly, many doctors were quick to condemn ketamine and claim that SSRIs are safer. According to <a href="https://www.sciencemediacentre.org/expert-reaction-to-comments-by-elon-musk-about-use-of-ketamine-for-depression/" target="_blank" rel="noopener noreferrer">Dr. R. McShane</a>, associate professor at the Department of Psychiatry at the University of Oxford,&nbsp;<blockquote>Using ketamine as the first alternative instead of an SSRI is not something I would recommend … The risks of long term ketamine include tolerance, which depends on the dose and how frequently it is taken. The risks of long term SSRIs are better understood.</blockquote>Dr. McShane added that,&nbsp;<blockquote>People who try to treat themselves without medical help tend to take more ketamine (ie higher doses and more frequently) than if they were being prescribed it medically.</blockquote>Presumably, this argument could be extended to any OTC medication, including SSRIs if they become OTC.&nbsp;Just waiting for a brave Pharma company to step upProf. Perlis concludes his article with the hope that,&nbsp;<blockquote>… an SSRI manufacturer [will emerge] with the courage to engage with the FDA and invest the necessary resources for a prescription-to-OTC switch, a well-trod path…</blockquote>Clearly, he is convinced that SSRIs fulfill the FDA's <a href="https://www.fda.gov/drugs/drug-application-process-nonprescription-drugs/prescription-nonprescription-rx-otc-switches" target="_blank" rel="noopener noreferrer">criteria </a>for OTC drugs: they can be used for self-diagnosed conditions; there is no need for a doctor's involvement to ensure safe usage; and there is only a “low” potential that the drugs will be misused or abused.For other <a href="https://www.mdedge.com/psychiatry/article/105092/depression/should-ssris-be-sold-over-counter" target="_blank" rel="noopener noreferrer">psychiatrists</a> (and many laypeople), the idea remains “unthinkable.”<blockquote>These medications, after all, carry a black box warning…</blockquote>

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Psychiatric Drug

Why not? After all, they are 'proven' safe and effective...

OTC anti-depressants? Harvard Medical School professor says yes

<h2>Understanding synthetic biology (synbio)</h2><h3>What it is</h3>We've been hearing a lot about synthetic biology in terms of synthetic foods, yet synbio is more than just an attempt to recreate food, which Frontline News has <a href="https://frontline.news/post/got-milk-it-may-not-be-real" target="_blank" rel="noopener noreferrer">written</a> about in relationship to synthetic “milk.” Synbio genetic engineers are also interested in reproducing biological organisms and creating new biological products not found in nature. Following are a few definitions of synbio to show what it encompasses:<a href="https://en.wikipedia.org/wiki/Synthetic_biology" target="_blank" rel="noopener noreferrer">Wikipedia</a> - making new biological products or redesigning existing ones:<blockquote>Synthetic biology is a multidisciplinary field of science that focuses on living systems and organisms, and it applies engineering principles to develop new biological parts, devices, and systems or to redesign existing systems found in nature. -&nbsp;</blockquote><a href="https://www.newhope.com/industry-insights/synthetic-biology-test-could-force-the-natural-products-industry-to-define-its-position" target="_blank" rel="noopener noreferrer">New Hope Network</a> - using fermentation as mini-factories to recreate natural products:<blockquote>Ultimately, synbio is an attempt to re-create something that occurs in nature by using microorganisms to act as mini-factories,” explains Dana Perls, food and technology program manager at Friends of the Earth.&nbsp;</blockquote><a href="https://www.genome.gov/about-genomics/policy-issues/Synthetic-Biology" target="_blank" rel="noopener noreferrer">Genome.gov</a> - redesigning organisms for new purposes and recreating substances in nature through artificial means:<blockquote>Synthetic biology is a field of science that involves redesigning organisms for useful purposes by engineering them to have new abilities. Synthetic biology researchers and companies around the world are harnessing the power of nature to solve problems in medicine, manufacturing and agriculture.Redesigning organisms so that they produce a substance, such as a medicine or fuel, or gain a new ability, such as sensing something in the environment, are common goals of synthetic biology projects.&nbsp;</blockquote><a href="https://www.ecofarmingdaily.com/culture-of-disruption/" target="_blank" rel="noopener noreferrer">Jim Thomas, in an interview with Eco Farming Daily</a> - treating biology as a computer program (Jim Thomas is a technology historian and long-time critic of the biotech industry):<blockquote>The core assumptions of synthetic biology are that life is a sort of computer program, that DNA is like a code and that a cell or living organism is like a computer or a machine. As long as you can “reprogram” the DNA — the instructions — then you can engineer the machine to do whatever you want it to do.&nbsp;</blockquote><h3>Products created using synthetic biology</h3><a href="https://www.newhope.com/industry-insights/synthetic-biology-test-could-force-the-natural-products-industry-to-define-its-position" target="_blank" rel="noopener noreferrer">New Hope Network</a> author Melaina Juntti said that many synbio products are already in many foods and are finding their way into dietary supplement supply chains, also. She referred to the Non-GMO Project's director of marketing and communications, Hans Eisenbeis, who said that some synbio products have already been commercialized or are in development such as “vanillin and other flavorings, several colorants, CBD, collagen, plant-based proteins, dairy proteins, vitamins, omegas, probiotics and dairy milk proteins.”&nbsp;In addition to Eisenbeis's list, Health Research Institute–HRI Labs chairman and chief scientist, John Fagan, Ph.D., added “astaxanthin, resveratrol, and squalene to the growing list.”<a href="https://www.nature.com/articles/s41467-020-20122-2" target="_blank" rel="noopener noreferrer">Nature</a> provides this list of synbio&nbsp;generated products:<ul><li>Hemme used to make the “blood” for the Impossible Burger: “The yeast Pichia pastoris was engineered to produce soy leghemoglobin, which improves meaty flavors and aromas when added to a plant-based burger.”</li><li>Other synbio products created by fermenting yeast include Vitamin E, stevia, and milk whey. Plant pathways to pharmaceuticals include taxadiene (Taxol precursor), steroids, THC, and opiates. “An early landmark achievement to make the anti-malarial Artimisin was taken into production by Sanofi, but was discontinued because the cost was higher than sourcing it from the plant.”</li><li>Januvia (sitgaliptin) is a diabetes medication manufactured by Merck. “It is the 95th most-prescribed drug with ~107 prescriptions and $1.35 billion in annual sales.”</li><li>Hyaline transparent and flexible film for electronics.&nbsp;</li><li>ProveN fertilizer being applied to corn. “Pivot Bio has created the first biological fertilizer for corn based on a γ-proteobacterium (KV137) that associates with corn roots and has the necessary genes to fix nitrogen. However, the genes are off when most needed, so synthetic biology was used to turn the genes on, which guided the remodeling of the KV137 genome.”</li><li>Kymriah, a treatment for B-cell acute lymphoblastic leukemia by Novartis, is produced by genetically modifying a patient’s T cells and is deemed an “effective living therapy.” Using engineered living cells for therapeutic purposes has been considered to be the “3rd pillar of medicine.” &nbsp;Kymriah (Tisagenlecleucel) is the first of its type to receive FDA approval.</li><li>Calyno high-oleic oil from soy “is the first product from a genome-edited plant to enter the United States food supply.” Calyno manufacturer Calyxt edited the soy genome to reduce the amount of unstable linoleic acid to create an oil containing 80% oleic acid rather than 20% in unmodified oil. To do this, Calyxt inactivated two fatty acid desaturase genes that reduce the production of the unstable linoleic acid.&nbsp;</li></ul>Nature author Chris Voigt provides a futuristic look at what else might be done with synbio such as bee-copters to transport people and trees that grow into houses. Scientists are looking to create biology-derived components. Voigt says that “[t]he next decade will see more products that derive their superior performance and affordability from engineered biology.”&nbsp;<a href="https://www.genome.gov/about-genomics/policy-issues/Synthetic-Biology" target="_blank" rel="noopener noreferrer">Genome.gov</a> provides some examples of what scientists are producing with synthetic biology,:<blockquote><ul><li>Microorganisms harnessed for bioremediation to clean pollutants from our water, soil and air.</li><li>Rice modified to produce beta-carotene, a nutrient usually associated with carrots, that prevents vitamin A deficiency. Vitamin A deficiency causes blindness in 250,000 - 500,000 children every year and greatly increases a child's risk of death from infectious diseases.</li><li>Yeast engineered to produce rose oil as an eco-friendly and sustainable substitute for real roses that perfumers use to make luxury scents.</li></ul></blockquote><h2>What could go wrong?</h2>According to Thomas, original GMOs which involved moving a single gene from one organism to another consistently produced unexpected results. Synthetic biology which is more complex will certainly lead to a greater degree of unexpected results. One such scenario, he said, would involve an organism engineered to break down cellulose that gets out into the environment:<blockquote>Let’s say you have an organism engineered to break down cellulose. If it got out into the environment, there is plenty of cellulose in our houses, clothes and fields to survive on. And we don’t know how it would change with evolution or whether it would produce toxins. Those are some of the worrying scenarios.</blockquote>Thomas wasn't pulling an example out of the air, either. He recounted a previous experience with a GMO bacteria that was designed to break down cellulose, but astute researchers discovered that it would yield unwanted results and were able to halt its release before it could do damage:<blockquote>Klebsiella planticola was a bacterium genetically engineered to break down cellulose. Fortunately, a couple of researchers looking at its impacts in the soil found that it would produce an alcohol that would kill plant roots and they were able to halt the release before it happened</blockquote>Living systems have a will to live.<blockquote>In fact, a lot of the initial work in synthetic biology sought to engineer organisms to break down cellulose into alcohol for ethanol production. If instead you break down cellulose and turn it into vanilla and that gets into the soil, we don’t know if that’s a problem. And that’s assuming that it’s going to do the thing it’s expected to do. These are living systems that evolve and have a will to live.</blockquote>New Hope further quoted Dana Perls saying that we don't understand nature well enough to know that what we are doing is totally safe.&nbsp;<blockquote>&nbsp;The problem is we don’t understand enough about how nature works to do it in a way that we can be sure is safe for human health and the environment and sustainable for small farmers.Despite biotech and agribusiness’s insistence that synbio is safe and eco-friendly, nobody knows for sure whether that’s true. Unlike first-generation GMOs—primarily plants modified with DNA from another species—this new form of gene editing is totally unregulated. USDA and FDA limit their oversight of genetically engineered products to those containing foreign DNA, which synbio ingredients typically do not have. Thus, the DARK Act of 2018, which mandates labeling of “bioengineered” foods, is of little use.</blockquote>Claims of “natural” are not accurate.<blockquote>New biotech companies are trying to pull the wool over FDA and USDA by claiming to be making ‘nature-identical’ products. But these products are not natural and are far from identical—they are genetically engineered.</blockquote><h2>Consumers and food manufacturers in the dark</h2>Consumers, New Hope's Junti wrote, are mostly unaware of synbio, even those who want GMOs labeled. And, it's not just the consumers who don't know what they're buying, she says, but the “[m]any food and dietary supplement manufacturers are also unaware of the true identity of ingredients they’re purchasing.”Related articles:<ul><li><a href="https://frontline.news/post/got-milk-it-may-not-be-real">Got milk? It might not be real</a>&nbsp;</li><li><a href="https://frontline.news/post/equating-lab-grown-meat-with-animal-meat-is-kooky-thinking-alliance-for-natural-health" target="_blank" rel="noopener noreferrer">Equating lab-grown meat with animal meat is 'kooky thinking' - Alliance for Natural Health</a></li><li><a href="https://frontline.news/post/lab-grown-meat-not-slaughter-free-not-climate-friendly-as-claimed-can-it-cause-cancer-too">Lab-grown meat not slaughter-free, not climate-friendly as claimed. Can it cause cancer too?</a></li><li><a href="https://frontline.news/post/a-little-bit-of-pfizer-in-your-cheese-fake-rennet-bypassed-additive-approval-process">A little bit of Pfizer in your cheese? Fake rennet bypassed additive approval process</a></li><li><a href="https://frontline.news/post/can-t-digest-cheese-maybe-you-can-tolerate-cheese-made-with-natural-rennet-instead-of-pfizer-s-gmo-version">Can't digest cheese? Maybe you can tolerate cheese made with natural rennet instead of Pfizer's GMO version</a></li><li><a href="https://frontline.news/post/fake-milk-inferior-to-real-milk-experts-find">Fake milk inferior to real milk, experts find</a></li><li><a href="https://frontline.news/post/fake-meat-sales-plummet-amid-falling-demand">Fake meat sales plummet amid falling demand</a></li><li><a href="https://frontline.news/post/fake-meat-industry-continues-to-plunge">Fake meat industry continues to plunge</a></li><li><a href="https://frontline.news/post/italy-becomes-first-country-to-ban-fake-food">Italy becomes first country to ban fake food</a></li><li><a href="https://frontline.news/post/fakefood-another-safe-ingredient-may-pose-health-threat">#FakeFood: Another ‘safe’ ingredient may pose health threat</a></li></ul>

DNA genetic engineering.jpg

Technology

'These products are not natural and are far from identical—they are genetically engineered'

What is synthetic biology and why should you care?

<h2 style="margin-left:0px;">Faux milk gaining ground</h2>The synbio (synthetic biology) industry is developing synthetic animal proteins including <a href="https://frontline.news/post/equating-lab-grown-meat-with-animal-meat-is-kooky-thinking-alliance-for-natural-health" target="_blank" rel="noopener noreferrer">lab-grown meat</a> and <a href="https://frontline.news/post/got-milk-it-may-not-be-real" target="_blank" rel="noopener noreferrer">synbio milk</a>. In its coverage of synbio milk, Frontline News referred to a review by Su-Jit Lin of the HuffPost about Bored Cow, a company selling its synbio milk as "The first milk alternative to do it all."&nbsp;“All,” in this sense, means animal-free, vegan-friendly, nutritionally equivalent to milk, and useful in foods, cooking, and baking in the same ways as real milk, as Frontline News reported:<blockquote>Lin reported Ben Berman, co-founder, and CEO of Bored Cow, made, stating that Bored Cow was created to “replicate the taste, texture, nutrition and functionality of conventional dairy milk” and has a nutrition panel nearly identical, if not better than the generic milk he had in his fridge.&nbsp;</blockquote>Several other companies, as Frontline News highlighted, were also producing faux milk and cheese products, making the same claims as Bored Cow, that their products are good for animals, people, and the environment. &nbsp; &nbsp;<h4 style="margin-left:0px;">Reason to doubt</h4>Frontline News has previously reported on <a href="https://frontline.news/post/lab-grown-meat-not-slaughter-free-not-climate-friendly-as-claimed-can-it-cause-cancer-too" target="_blank" rel="noopener noreferrer">claims</a> by manufacturers of lab-grown meat which didn't hold up. Similarly, <a href="https://frontline.news/post/child-slave-labor-in-producing-ev-batteries-raises-serious-questions-about-clean-green-technologies" target="_blank" rel="noopener noreferrer">claims</a> by proponents of EV cars turned out to be dubious. It was, therefore, natural to wonder about the veracity of claims made by synbio milk manufacturers.<blockquote>Considering the magnitude of the synbio dairy industry, it is important to ask if the claims made by Bored Cow and other synbio dairy manufacturers are accurate.&nbsp;</blockquote>That is the topic of this article.<h2 style="margin-left:0px;">What could possibly go wrong?</h2>Despite Lin's enthusiastic report, there are many problems associated with synbio milk.<h3 style="margin-left:0px;">Specious claims</h3>Faux milk is promoted as being the same as real milk since the “precision fermentation” process used is based on a yeast genetically modified to produce whey protein, as <a href="https://anh-usa.org/frankenfoods-v2-exploiting-the-bioequivalence-principle/" target="_blank" rel="noopener noreferrer">explained</a> by the Alliance for Natural Health:<blockquote>Bored Cow is made with whey protein produced through a process called “precision fermentation,” a form of synbio. This involves taking a gene for whey protein and inserting it into a GE yeast. The yeast is put into fermentation tanks with other nutrients to help it grow. At the end the GE yeast is supposed to be filtered out, leaving only the milk protein. Bored Cow takes this protein and adds vitamins, minerals, and other ingredients to mimic the taste, consistency, and nutritional content of real cow’s milk.</blockquote>As Lin reported, Ben Berman, co-founder, and CEO of Bored Cow, boasted that his company's synthetic milk is as good as cow's milk. Berman said that Bored Cow has a nutrition panel nearly identical, if not better, than the generic milk he had in his fridge. &nbsp;However, as ANH explained, it is not likely that synbio milk is equivalent to real milk, because of the complexity of real milk. Cow's milk is more than just the vitamins listed on the nutrition panel.<blockquote>[It is not] very likely that Bored Cow is nutritionally equivalent to real milk. Just as meat is more than just protein, milk is far more than a simple combination of whey and various vitamins and minerals. Milkfat contains 400 different fatty acids. Milk has two types of proteins, whey and casein—and there are several different types of these two proteins contained in milk, and a whole bundle of other compounds like lactoferrin and bioactive peptides that help prime the immune system.</blockquote><h3 style="margin-left:0px;">Nutritional dark matter - 92 unknown compounds&nbsp;</h3>When the Iowa-based Health Research Institute (HRI) tested Bored Cow's faux milk using full-spectrum molecular analysis technology, they discovered 92 compounds that are yet to be identified, and the presence of which are not noted on the nutritional panel. As Ken Rosenboro, editor for the Organic and Non-GMO Report <a href="https://non-gmoreport.com/not-so-precise-fermentation-lab-finds-92-unknown-compounds-in-synthetic-biology-milk/" target="_blank" rel="noopener noreferrer">wrote</a>, HRI's chief science officer John Fagan was concerned that they could not identify those compounds.<blockquote>Calling them completely novel to our food,” he says. “They are things that we haven’t consumed as human beings.”Fagan scanned scientific literature and databases to determine whether the molecules had nutritional or other beneficial properties and found nothing.“I couldn’t even find the scientific name for the vast majority of the molecules present in the Bored Cow product. They are nutritional dark matter,” Fagan says.Fagan speculated that the unknown molecules could either be nutrients or waste products created during the fermentation process, stating that if they are waste products you wouldn't “necessarily want them in your food.”</blockquote><h3 style="margin-left:0px;">GMO without the designation</h3>Rosenboro noted that Bored Cow and Perfect Day, the company that manufactures the whey protein Bored Cow uses, avoid using the term genetically engineered to describe the yeast used in the production of the whey protein, preferring “microflora” instead.&nbsp;<blockquote>Bored Cow and Perfect Day use the term “microflora” to avoid using “genetically engineered” or “GMO.”&nbsp;</blockquote><h3 style="margin-left:0px;">Not cow protein&nbsp;</h3>As if the 92 unidentifiable compounds were not enough of a problem, HRI also found that the fake milk's protein, assumed to be cow protein, was mostly from the GMO yeast and not the milk protein.&nbsp;<blockquote>Perfect Day and Bored Cow both claim the milk protein is identical to the protein in cow’s milk but HRI’s tests found that the protein in Bored Cow’s milk was mostly from the GMO yeast and not the milk protein.</blockquote>The amino acids in the product were also different from those in real milk.<blockquote>“The amino acid composition of the protein that’s present in the Bored Cow milk is strikingly different from the amino acid composition of real milk,” Fagan says. “We have data that shows this is the case.”</blockquote><h3 style="margin-left:0px;">Have some GMO DNA with your Bored Cow</h3>Fagan said that the GMO-derived microflora or yeast, which was supposed to have been removed during fermentation, was still found in the final product, Rosenboro also reported:<blockquote>“The (genetically engineered) DNA in these products is broken up or fragmented but is certainly still there,” Fagan says.Further he says tests are being developed to detect the GMO DNA in synthetic biology products like Bored Cow.</blockquote>GMO DNA in synbio products would have to be labeled as such under the bioengineered food disclosure law.<blockquote>“The reality is that all that’s required is to do a little bit of molecular biology and a GMO test can be developed for synbio products,” says Fagan who pioneered creating laboratory tests for GMO corn and soybeans when they were first commercialized in the late 1990s.The presence of GMO DNA in Bored Cow and other synbio products would mean that they would have to be labeled under the U.S. Department of Agriculture’s National Bioengineered Food Disclosure law. Right now, such products don’t require labeling.</blockquote><h3 style="margin-left:0px;">No safety assessments</h3>Rosenboro explained that the FDA does not require safety assessments for synbio milk. That milk, however, with its 92 unknown compounds, would have to undergo testing in Europe and Canada as a novel food.&nbsp;ANH <a href="https://anh-usa.org/frankenfoods-v2-exploiting-the-bioequivalence-principle/" target="_blank" rel="noopener noreferrer">elaborated</a> on the lack of safety assessment, explaining that Perfect Day, the manufacturer of the synbio whey protein used by Bored Cow, like some food manufacturers, claimed on its own that its product was GRAS (generally recognized as safe), utilizing the FDA's expedited process of GRAS <a href="https://qualitysmartsolutions.com/self-affirmed-gras/" target="_blank" rel="noopener noreferrer">self-affirmation</a> which does not require FDA review.<blockquote>The FDA must be on top of this, right? Wrong. Bored Cow has not undergone safety testing at the FDA. Perfect Day, the manufacturer of the synbio whey protein, determined it was “generally recognized as safe” (GRAS) and voluntarily notified the FDA of this determination; in response the FDA said it had no questions. Given how rife the GRAS process is with conflicts of interest, this is akin to taking the company’s word for it that its novel synbio whey protein is safe.</blockquote><h3 style="margin-left:0px;">Climate-friendly? Not so fast&nbsp;</h3>Rosenboro referred to an article in Forbes by Errol Schweizer, partner of food and agriculture at Impakt, IQ, who questioned the claim that synbio is sustainable and climate-friendly. He wanted to know how the waste material would be disposed of; the amount of energy and resources used as compared to animal-based products; and the use of high-fructose corn syrup to feed the yeast as corn production is energy intensive and polluting.&nbsp;<h3 style="margin-left:0px;">Biology doesn't work like a computer program</h3>Synbio products are being likened to a computer program so all that needs to be done is to program the DNA like a computer, a flawed assumption according to Fagan. The analogy doesn't hold water, he says, since even yeast is infinitely more complicated than computer programs.<blockquote>An article in FoodNavigator USA even describes GMO yeasts being “programmed” to produce proteins. The problem is that the internal functioning of even the simplest organisms like a yeast is vastly more complex than computer programs.“It is a hollow analogy because it implies that you have the same kind of precise control in synthetic biology that you have programming a computer. It’s much more complex,” Fagan says. “Here we have an example of 92 unpredicted compounds being produced, and only a trace of the whey protein that you really want. It’s nothing like precision.” &nbsp;</blockquote>In the tweet below, Millions Against Monsanto links to a lecture by John Fagan about precision fermentation.<blockquote><div class="raw-html-embed"><blockquote class="twitter-tweet">Listen to Dr. John Fagan’s Concerning New Findings: <a href="https://t.co/FruJ15ACrz">https://t.co/FruJ15ACrz</a> "His latest research takes aim at the synthetic biology industry, also called 'precision fermentation.'" <a href="https://t.co/3ZCZdgRuWW">pic.twitter.com/3ZCZdgRuWW</a>— Millions Against Monsanto (@againstmonsanto) <a href="https://twitter.com/againstmonsanto/status/1759246872303087825?ref_src=twsrc%5Etfw">February 18, 2024</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div></blockquote>Related articles:<ul><li><a href="https://frontline.news/post/danger-ahead-changing-the-natural-world-with-genetic-engineering-and-artificial-intelligence" target="_blank" rel="noopener noreferrer">Danger ahead! Changing the natural world with genetic engineering and artificial intelligence</a></li><li><a href="https://frontline.news/post/got-milk-it-may-not-be-real" target="_blank" rel="noopener noreferrer">Got milk? It might not be real</a></li><li><a href="https://frontline.news/post/equating-lab-grown-meat-with-animal-meat-is-kooky-thinking-alliance-for-natural-health" target="_blank" rel="noopener noreferrer">Equating lab-grown meat with animal meat is 'kooky thinking' - Alliance for Natural Health</a></li><li><a href="https://frontline.news/post/lab-grown-meat-not-slaughter-free-not-climate-friendly-as-claimed-can-it-cause-cancer-too">Lab-grown meat not slaughter-free, not climate-friendly as claimed. Can it cause cancer too?</a></li><li><a href="https://frontline.news/post/a-little-bit-of-pfizer-in-your-cheese-fake-rennet-bypassed-additive-approval-process">A little bit of Pfizer in your cheese? Fake rennet bypassed additive approval process</a></li><li><a href="https://frontline.news/post/can-t-digest-cheese-maybe-you-can-tolerate-cheese-made-with-natural-rennet-instead-of-pfizer-s-gmo-version">Can't digest cheese? Maybe you can tolerate cheese made with natural rennet instead of Pfizer's GMO version</a></li><li><a href="https://frontline.news/post/fake-milk-inferior-to-real-milk-experts-find">Fake milk inferior to real milk, experts find</a></li><li><a href="https://frontline.news/post/fake-meat-sales-plummet-amid-falling-demand">Fake meat sales plummet amid falling demand</a></li><li><a href="https://frontline.news/post/fake-meat-industry-continues-to-plunge">Fake meat industry continues to plunge</a></li><li><a href="https://frontline.news/post/italy-becomes-first-country-to-ban-fake-food">Italy becomes first country to ban fake food</a></li><li><a href="https://frontline.news/post/fakefood-another-safe-ingredient-may-pose-health-threat">#FakeFood: Another ‘safe’ ingredient may pose health threat</a></li></ul>

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What is synthetic biology and why should you care?

'Nutritional dark matter' in Bored Cow's synbio milk - 92 unknown compounds