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🚨 S&P 500 DRAWDOWN AFTER AUGUST IN EVERY RECENT MIDTERM ELECTION YEAR: 1962: -12.3% 1966: -18.2% 1966: -7.1% 1974: -28.6% 1978: -9.3% 1982: -27.1% 1986: -8.4% 1990: -18.2% 1994: -9.3% 1998: -18.3% 2002: -21.1% 2006: -6.9% 2010: -16.0% 2014: -11.2% 2018: -21.2% 2022: -16.9% NOT A SINGLE POSITIVE RETURN...

1,005,289 просмотров • 28 дней назад •via X (Twitter)

Комментарии: 34

Фото профиля Not a Hypocrite
Not a Hypocrite27 дней назад

I copied your message and asked both ChatGpt and Claude to fact check. Both said this is BS. “No. The post is badly misleading, and parts of the table are simply wrong.”

Фото профиля Federico Giorgi
Federico Giorgi27 дней назад

Completely false. Just calculated it with R, price week before/after 1962: −11.8% 1966: −13.1% 1970: +0.1% 1974: −29.7% 1978: +1.1% 1982: +14.8% 1986: +14.6% 1990: −6.6% 1994: −1.5% 1998: +26.7% 2002: −23.4% 2006: +13.6% 2010: +12.8% 2014: +11.4% 2018: −6.2% 2022: −19.4%

Фото профиля Mr. Cypherpunk
Mr. Cypherpunk27 дней назад

It gained 16 percent not dropped in 2010

Фото профиля Pictoshi
Pictoshi27 дней назад

I’m not gonna lie, your chart makes it seem like there’s nearly zero correlation to midterms lol

Фото профиля Ricardo
Ricardo27 дней назад

Grok disagrees

Фото профиля William Kourakos
William Kourakos27 дней назад

100% False. From September 1 to election day: Ave return is 2.6% with positive returns in 62% of those elections.

Фото профиля WAGMI
WAGMI27 дней назад

Ahh yes I too remember the great 1966 drawdown we had to go through twice!

Фото профиля matt miller 🇺🇦 🇵🇱𝕏
matt miller 🇺🇦 🇵🇱𝕏27 дней назад

Grok Fixed it for you!

Фото профиля Godzilla Trader 🦖
Godzilla Trader 🦖27 дней назад

How many had a -10% correction earlier in the same year?

Фото профиля That JooFO Guy 🇮🇱🫶🏼👽
That JooFO Guy 🇮🇱🫶🏼👽27 дней назад

@grok what has been the average return of the S&P 500 Index, three months after the US mid-term elections, over the past 10 election cycles? Tabulate each individual year’s return.

Фото профиля Ben chabot
Ben chabot27 дней назад

Aren’t drawdowns negative by construction?

Фото профиля MrTopStep
MrTopStep27 дней назад

BS

Фото профиля kizzy
kizzy27 дней назад

Every single historical data point mentioned on my timeline this year has gone the other way.

Фото профиля Smith-Mundt Vibes
Smith-Mundt Vibes27 дней назад

You forgot to change the 2nd 1966 to 1970

Фото профиля Mike Garcia
Mike Garcia27 дней назад

This is one of those “the sky is falling” accounts. I would completely ignore.

Фото профиля Trade Control HQ
Trade Control HQ27 дней назад

“Drawdown was negative every midterm year for 60 years” sounds really good until you realize every year has a drawdown. A drawdown is measured peak to trough. It’s basically saying the daily low was below the daily high every day for 60 years. True, but useless. Better question. How big does the drawdown usually get and are you positioned to sit through it?

Фото профиля The Twilight of Human History 🌇
The Twilight of Human History 🌇27 дней назад

@grok 核实数据

Фото профиля Luca
Luca27 дней назад

Guys those figures are true as max drawdown max to bottom of the year but they didn’t occur after August! Please be aware of his false claims!

Фото профиля Anthony Baccari
Anthony Baccari27 дней назад

Mute accounts that give the opposite of factual info. Terrible investors always give fake stats and false info. They don't deserve the engagement.

Фото профиля Özgür AKBAŞ
Özgür AKBAŞ27 дней назад

What about Gold and Silver during those periods?

Фото профиля Maslov
Maslov27 дней назад

The scariest part isn’t this chart… 👀 It’s that EVERYONE is now expecting the crash. Markets have a funny way of destroying the most obvious trade. 💀📉📈

Фото профиля SwanShapedBird
SwanShapedBird27 дней назад

Damn, the shortsellers and bears are getting desperate.

Фото профиля David
David27 дней назад

A drawdown by definition is always a negative number.

Фото профиля JP investimentos
JP investimentos27 дней назад

1970?

Фото профиля Baby Gosling
Baby Gosling27 дней назад

What about 24 and 25 bud you seemed to have conveniently left those out.

Фото профиля Pablo Cappellato
Pablo Cappellato27 дней назад

we had 2 1966 septembers, cool. the second one was better

Фото профиля Mark Sellers
Mark Sellers26 дней назад

Mostly misleading, and sloppy on top of it. Two issues: 1.1966 is listed twice; 1970 is missing. That alone tells you the list wasn’t carefully assembled. 2.“Drawdown” ≠ “return.” Any 4-month window has some peak-to-trough dip. Actual Sep–Dec total returns were solidly positive in 1982, 1986, 1998, 2006, 2010, and others. The “not a single positive return in 60 years” line conflates the two — every period looks negative if you only measure peak to trough. So the numbers aren’t fabricated so much as cherry-framed to mean something they don’t.

Фото профиля Ace_T_Role
Ace_T_Role27 дней назад

Everyone now knows this so they will sell to institutions and it will go up this year. T hey will them buy higher.

Фото профиля bgive
bgive27 дней назад

If it’s true then I’m ready 😎

Фото профиля Mike Garcia
Mike Garcia27 дней назад

Little deceptive how you are showing the data. In 2022 for example we saw a little September dip that recovered quickly and then chopped around a bit thru the end of the year. Little bit of doom bating here.

Фото профиля NomadProsper 🏖
NomadProsper 🏖27 дней назад

What a dork! not even close to true.

Фото профиля Dave Hunsaker
Dave Hunsaker27 дней назад

For 81 years, during a mid-term election year, from October to the following October, the S&P 500 has NEVER declined. Its average gain has been 16%.

Фото профиля Deezy (Nick Valdez)
Deezy (Nick Valdez)26 дней назад

100% false slop, blocking and moving on

Фото профиля Brian Morgan
Brian Morgan27 дней назад

• Fact-check replies and calculations show the listed figures are inaccurate, with multiple years posting positive returns from late summer onward including 1970 (+0.1%), 1978 (+1.1%), 1982 (+14.8%), and 2010 (+12.8%).

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🚨 WE ARE NOW ENTERING THE HOTTEST PHASE Every midterm election year for the last 50 years has delivered a market drawdown: 1974 Ford: -35% 1978 Carter: -15% 1982 Reagan: -17% 1986 Reagan: -9% 1990 Bush: -20% 1994 Clinton: -8% 1998 Clinton: -22% 2002 Bush: -34% 2006 Bush: -8% 2010 Obama: -17% 2014 Obama: -7% 2018 Trump: -20% 2022 Biden: -27% 2026 Trump: ??? 13 midterm years. 13 drawdowns. Average intra-year drawdown: ~17%. But this year there’s another cycle hitting at the SAME time. A new Fed chair. Over the last nine decades: 12 new Fed chairs. 12 equity drawdowns within their first three months. Average: -12%. The last time both cycles collided was 2018. Powell became Fed chair. Markets broke almost immediately. By Christmas Eve: S&P 500: -20% Then Powell pivoted. 2019: S&P 500: +30% And now the timing gets even more interesting. Market fear historically bottoms in early summer. Then rises into September and October. The VIX was near the mid-teens in July. Now it’s already above 18. At the same time: Retail cash allocations are near extreme lows. Almost nobody is hedging. Record IPO supply is draining liquidity. And we’re entering the exact window where midterm-year corrections historically accelerate. But here’s what most people will get wrong: This is NOT where I become bearish long term. Every one of those 13 midterm drawdowns became a buying opportunity. 13 out of 13. Average rally from the midterm low: ~47%. That’s the opportunity I’m waiting for. First the fear. Then the bottom. The next 60 days could create the best buying opportunity of this cycle. Keep in mind: I publicly called Bitcoin’s $17K bottom in 2022 and the $126K top in 2025. When I start buying again, every call will be posted here first. Follow and turn notifications on.

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88,598 просмотров • 20 дней назад

🚨 S&P 500 FALLS IN THIS PERIOD 93% OF CASES 🚨 Every midterm election year since 1962 (May to October) = market dump Not sometimes. 15 out of 16 times The worst ones: - 1962: -22.16% - 1966: -21.22% - 1974: -33.1% - 2002: -30.54% - 2022: -18.9% Recessions, bubbles, rate cycles - none of it broke the pattern So what's actually driving this? Three things And they hit at the same time. every single cycle 1. THE PRESIDENTIAL CYCLE New presidents always front-load the difficult decisions - Tax reform - Spending cuts - Policy shifts Nobody wants to do this close to re-election So they push it all into the FIRST TWO YEARS The market absorbs all of that pain during the midterm window Years 3 and 4 flip the script - stimulus, rate cuts, liquidity back in the system Markets recover. President takes the credit Nobody mentions who caused the pain two years earlier 2. POLITICAL UNCERTAINTY Most people focus only on the president. They miss the bigger story Midterms can flip Congress overnight When that happens - taxes change, spending changes, every regulation is on the table Big money doesn't wait to find out which way it goes It reduces exposure before the vote and comes back once the dust settles Uncertainty doesn't just slow markets. It empties them That's exactly why smart money moves in May And why "Sell in May and go away" exists 3. THE FED TIMING PROBLEM There's a reason the Fed always seems to get the timing wrong They don't. It's intentional Rates go up in year 1 and 2. That's the pain nobody talks about on camera Then rates come down in year 3 and 4 - right when the president needs good headlines before re-election Midterm year always lands at the top of that rate cycle The most expensive moment to borrow. The hardest moment to grow The Fed didn't miscalculate. The calendar just exposed them And then there's 2026 New president in year 2. Fed still restrictive. Congress up for grabs Every condition is in place. All three forces active at the same time My target: 6,200 by October That's a 17% decline from current levels History says this move is more likely than not Are you positioned for it? NOTIFS ON!

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66,571 просмотров • 4 месяцев назад

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Ignorance, the root and stem of all evil

112,008 просмотров • 5 дней назад

#WATCH Jeffrey Sachs Blasts US Power Grab Over Venezuela, Maduro Capture at Historic UN Meeting 🇺🇸 US military interventions in foreign countries since WWII (incomplete list): 🇮🇷 Iran: 1946 🇨🇳 China: 1946 - 1949 🇬🇷 Greece: 1947 - 1949 🇮🇹 Italy: 1948 🇵🇭 Philippines: 1948 - 1954 🇰🇵 Korea: 1950 - 1953 🇮🇷 Iran: 1953 🇻🇳 Vietnam: 1954 🇬🇹 Guatemala: 1954 🇱🇧 Lebanon: 1958 🇵🇦 Panama: 1958 🇭🇹 Haiti: 1959 🇨🇩 Congo: 1960 🇻🇳 Vietnam: 1960 - 1964 🇨🇺 Cuba: 1961 🇨🇺 Cuba: 1962 🇱🇦 Laos: 1962 🇪🇨 Ecuador: 1963 🇵🇦 Panama: 1964 🇧🇷 Brazil: 1964 🇻🇳 Vietnam: 1965 - 1975 🇮🇩 Indonesia: 1965 🇨🇩 Congo: 1965 🇩🇴 Dominican Republic: 1965 🇱🇦 Laos: 1965 - 1973 🇬🇭 Ghana: 1966 🇬🇹 Guatemala: 1966 - 1967 🇰🇭 Cambodia: 1969 - 1975 🇴🇲 Oman: 1970 🇱🇦 Laos: 1971 - 1973 🇨🇱 Chile: 1973 🇰🇭 Cambodia: 1975 🇦🇴 Angola: 1976 - 1992 🇮🇷 Iran: 1980 🇱🇾 Libya: 1981 🇸🇻 El Salvador: 1981 - 1992 🇳🇮 Nicaragua: 1981 - 1990 🇱🇧 Lebanon: 1982 - 1984 🇬🇩 Grenada: 1983 🇭🇳 Honduras: 1983 - 1989 🇮🇷 Iran: 1984 🇱🇾 Libya: 1986 🇧🇴 Bolivia: 1986 🇮🇷 Iran: 1987 - 1988 🇱🇾 Libya: 1989 🇵🇭 Philippines: 1989 🇵🇦 Panama: 1989 - 1990 🇱🇷 Liberia: 1990 🇮🇶 Iraq: 1990 - 1991 🇮🇶 Iraq: 1991 - 2003 🇭🇹 Haiti: 1991 🇸🇴 Somalia: 1992 - 1994 Yugoslavia: 1992 - 1994 🇧🇦 Bosnia: 1993 - 1995 🇭🇹 Haiti: 1994 - 1996 🇭🇷 Croatia: 1995 🇨🇩 Zaire (Congo): 1996 - 1997 🇱🇷 Liberia: 1997 🇸🇩 Sudan: 1998 🇦🇫 Afghanistan: 1998 🇮🇶 Iraq: 1998 Yugoslavia: 1999 🇲🇰 Macedonia: 2001 🇦🇫 Afghanistan: 2001 🇮🇶 Iraq: 2003 🇮🇶 Iraq: 2003-present 🇭🇹 Haiti: 2004 🇸🇾 Syria: 2011-present 🇺🇦 Ukraine: 2014-present 🇻🇪 Venezuela: 2026 The UN Security Council witnessed a rare, explosive intervention as economist Jeffrey Sachs delivered a sweeping warning on Venezuela. Speaking during an emergency session, Sachs framed the crisis as a test of international law itself, not leadership politics. He traced decades of U.S. regime-change actions, questioned the legality of force and sanctions, and warned of catastrophic consequences if UN rules collapse in a nuclear age. Since 1947, United States foreign policy has repeatedly employed force, covert action, and political manipulation to bring about regime change in other countries. This is a matter of carefully documented historical record. In her book Covert Regime Change (2018), political scientist Lindsey O’Rourke documents 70 attempted US regime-change operations between 1947 and 1989 alone. These practices did not end with the Cold War. Since 1989, major United States regime-change operations undertaken without authorization by the Security Council have included, among the most consequential: Iraq (2003), Libya (2011), Syria (from 2011), Honduras (2009), Ukraine (2014), and Venezuela (from 2002 onward). The methods employed are well established and well documented. They include open warfare; covert intelligence operations; instigation of unrest; support for armed groups; manipulation of mass and social media; bribery of military and civilian officials; targeted assassinations; false-flag operations; and economic warfare aimed at collapsing civilian life. These measures are illegal under the UN Charter, and they typically result is ongoing violence, lethal conflict, political instability, and deep suffering of the civilian population. The case of Venezuela The recent United States record with respect to Venezuela is clear. In April 2002, the United States knew of and approved an attempted coup against the Venezuelan government. In the 2010s, the United States funded civil society groups actively engaged in anti-government protests, notably in 2014. When the government cracked down on the protests, the US followed with a series of sanctions. In 2015, President Barrack Obama declared Venezuela to be “an unusual and extraordinary threat to the national security and foreign policy of the United States.” In 2017, at a dinner with Latin American leaders on the margins of the UN General Assembly, President Trump openly discussed the option of the US invading Venezuela to overthrow the government. During 2017 to 2020, the US imposed sweeping sanctions on the state oil company. Oil production fell by 75 percent from 2016 to 2020, and real GDP per capita (PPP) declined by 62 percent. The UN General Assembly has repeatedly voted overwhelmingly against such unilateral coercive measures. Under international law, only the Security Council has the authority to impose such sanctions. On 23 January 2019, the United States unilaterally recognized Juan Guaidó as “interim president” of Venezuela and on 28 January 2019 froze approximately $7 billion of Venezuelan sovereign assets held abroad and gave Guaidó authority over certain assets. These actions form part of a continuous United States regime-change effort spanning more than two decades. Recent United States global escalation In the past year, the United States has carried out bombing operations in seven countries, none of which were authorized by the Security Council and none of which were undertaken in lawful self-defense under the Charter. The targeted countries include Iran, Iraq, Nigeria, Somalia, Syria, Yemen, and now Venezuela. In the past month, President Trump has issued direct threats against at least six UN member states, including Colombia, Denmark, Iran, Mexico, Nigeria and of course Venezuela. These threats are summarized in Annex I to this statement. What is at stake today Members of the Council are not called upon to judge Nicolás Maduro. They are not called upon to assess whether the recent United States attack and ongoing naval quarantine of Venezuela result in freedom or in subjugation. Members of the Council are called upon to defend international law, and specifically the United Nations Charter. The realist school of international relations, articulated most brilliantly by John Mearsheimer, accurately describes the condition of international anarchy as “the tragedy of great power politics.” Realism is therefore a description of geopolitics, not a solution for peace. Its own conclusion is that international anarchy leads to tragedy. In the aftermath of World War I, the League of Nations was created to end the tragedy through the application of international law. Yet the world’s leading nations failed to defend international law in the 1930s, leading to renewed global war. The United Nations emerged from that catastrophe as humanity’s second great effort to place international law above anarchy. In the words of the Charter, the UN was created “to save succeeding generations from the scourge of war, which twice in our lifetime has brought untold sorrow to mankind.” Given that we are in the nuclear age, failure cannot be repeated. Humanity would perish. There would be no third chance. Measures required of the Security Council To fulfill its responsibilities under the Charter, the Security Council should immediately affirm the following actions: The United States shall immediately cease and desist from all explicit and implicit threats or use of force against Venezuela. The United States shall terminate its naval quarantine and all related coercive military measures undertaken in the absence of authorization by the Security Council. The United States shall immediately withdraw its military forces from within and along the perimeter of Venezuela, including intelligence, naval, air, and other forward-deployed assets positioned for coercive purposes. Venezuela shall adhere to the UN Charter and to the human rights protected in the Universal Declaration of Human Rights. The Secretary-General shall immediately appoint a Special Envoy, mandated to engage relevant Venezuelan and international stakeholders and to report back to the Security Council within fourteen days with recommendations consistent with the Charter of the United Nations, and the Security Council shall remain urgently seized of this matter. All Member States shall refrain from unilateral threats, coercive measures, or armed actions undertaken outside the authority of the Security Council, in strict conformity with the Charter. In Closing Mr. President, Distinguished Members, Peace and the survival of humanity depend on whether the United Nations Charter remains a living instrument of international law or is allowed to wither into irrelevance. That is the choice before this Council today. Thank you.

Ignorance, the root and stem of all evil

369,164 просмотров • 8 месяцев назад

A Twist in the Tale: Has BJP become the adda of corrupt? In the run up to the 2014 general elections, the BJP centred its campaign around alleged corruption under the Congress-led UPA government, promising ‘ache din’ . Several times during the campaign, Narendra Modi Ji grandiloquently promised to jail the corrupt. He was equally loud about bringing back 'all the looted money stashed away in Swiss banks and eliminating black money'. People gave BJP a decisive mandate and Modi became PM in 2014. On 8th November 2016 in a public broadcast PM Modi declared that Rs. 500 and Rs. 1000 notes would cease to be legal tender and grandiosely announced that the purpose of #demonetisation was to crackdown on corruption and eliminate black money. It, however, turned out to be spurious. Recently, Supreme Court Justice B. V. Nagarathna said in a conference in Hyderabad that in the Indian economy at that time, Rs 500 and Rs 1000 notes comprised 86% of the currency and wondered about the goal of the demonetisation exercise since 98% of those notes came back to banks. She also questioned about black money eradication as demonetisation became a good way of converting black money into white money. In 2017 the BJP government introduced #ElectoralBond Scheme, which was anonymous financial contributions to political parties, by amending several laws namely, the Representation of the People Act, 1951, the Companies Act, 2013, the Income Tax Act, 1961. Its avowed purpose was to enhance transparency and accountability in political funding by eliminating black money, corruption. etc. The Supreme Court has recently struck down this secret political funding as unconstitutional and directed disclosure of complete details of all electoral bonds. From the data available in public domain, thanks to the Supreme Court, it came to light that the BJP is the biggest beneficiary as out of total Rs. 11,450 crores it received Rs. 6,566 crores which is 57%. Contemporaneous evidence indicates that #ElectoralBonds have all the ingredients of a huge scam such as quid pro quo and corruption, shell and loss making companies donating to political parties huge sums of money suspected to be kickbacks, and laundering of black money. In order to shield our democratic process from foreign interference, the laws regulating foreign contributions prohibited political parties and candidates in elections from accepting foreign contributions. But the BJP government through Finance Acts, 2016 and 2018 amended with retrospective effect the Foreign Contributions (Regulation) Act, 2010 (#FCRA) by changing the definition of ‘foreign source’ not only condoning the past illegalities committed but also permitting political parties to receive foreign funds, and thereby paved way for foreign intrusion into our political and electoral process compromising our sovereignty. Further, notwithstanding the huge propaganda of alleged action against Foreign Funded NGOs, there has been a huge spike in #FCRA remittances since the 2014-15. While during the 20 years between financial years 1994-1995 and 2013-14 an amount of Rs. 1,51,036 Crores was received, during the 8 years between 2014-15 and 2023-24 Rs. 1,46,392 was received. Data for financial years 2022-23 and 2023-24 is not yet available. However, from the trends of #FCRA remittances in the preceding years it will be around Rs. 50,000 Crores together for both the financial years, making the total FCRA remittances during 10 year rule of BJP to be around Rs. 2,00,000 Crores which is humongous. Even if a small fraction of that huge amount of foreign funds has gone to political parties or candidates in elections, it amounts to serious subversion of our democracy and constitution. What sort of patriotism is this? Several months prior to 2014 general elections, a spate of alleged scams during UPA rule surfaced namely, Chit Fund scam, Chopper scam, Tatra truck scam, 2G Spectrum scam, CWG scam, Coal scam, Adarsh scam, etc. The courts, CBI, ED and IT proactively initiated action as a result several Congress and UPA leaders came under scanner. Though the BJP came to power on the anti-corruption plank, hardly any political leaders of significance was convicted, nor even paisa of black money stashed away in Swiss banks was brought back. On the other hand, the BJP has allegedly been misusing the law enforcement agencies to arm-twist the opposition political leaders under cloud either to defect to or align with the BJP. Out of 25 important opposition leaders who were allegedly under the scanner and joined BJP, 23 have reportedly got reprieve. Politicians like Andhra Pradesh CM YS Jagan who faces 38 criminal cases including 11 CBI and 7 ED cases, have been buying peace from the BJP. As a result none of his cases have seen the light of the day, notwithstanding the direction of Supreme Court to speed up trial of cases against politicians. Likewise, the DMK leaders namely, the Maran brothers, A. Raja, Karunanidhi’s daughter Kanimozhi have been acquitted, after they not so secretly cosied up to BJP, thanks to the lacklustre prosecution of their cases before the courts. These are only representative examples of how the BJP has become the adda for the leaders facing allegations of corruption, money laundering, etc. It is quite possible that some of them may be genuinely innocent. But as their innocence has been established only after their defection to or aligning with the ruling BJP, it creates dark shadows by raising serious moral questions. Last year, fourteen political parties approached the Supreme Court against the alleged misuse of central investigating agencies in arresting opposition political leaders and other citizens exercising their fundamental right to dissent and disagree with the ruling BJP. It was alleged that 95% of political leaders investigated by CBI and ED belong to opposition. That is, out of 121 prominent politicians facing ED probe between 2014 and 2022, 115 are opposition leaders who had been booked, raided, questioned or arrested. To wriggle out of or deflect the allegations of promoting corruption, shielding the corrupt who have joined or aligned with the BJP and targeting opposition leaders, etc, one of the standard refrains of the BJP has been that as Narendra Modi has no family he cannot be corrupt or has no motivation to be corrupt or shield the corrupt. That is a disingenuous argument. Late Jayalalitha, who was a spinster with no family, was convicted for corruption and was sent to jail. There are many prominent leaders who are unmarried or have no families facing cases or allegations of corruption. I don’t mean to even hint let alone allege that Narendra Modi is personally financially corrupt. I merely want to call out their bluff by highlighting the point that there is no connection between one’s familial status and corruption. It must be recalled that Manmohan Singh, whose personal financial integrity was impeccable, presided over a corrupt regime. As such, personal financial honesty of PM or a CM is meaningless if his party and government are not honest. Barring honourable exceptions, every political party while in opposition grandiloquently talks against corruption, not necessarily because they are honest, but because they try to make a virtue of out of lack of opportunities to make money. Notwithstanding its anti-corruption rhetoric the BJP is no stranger to corruption as its unsavory history tells. In 2001, none other than its National President late Bangaru Laxman was caught on the camera taking bribe from one Mathew Samuel, and was later convicted by a Special CBI Court on 27th April 2012 and sentenced to four years in jail. Further, BJP’s former CM of Karnataka Sri B. S. Yeddyurappa faced charges of corruption and was also in jail for a while. There are allegations of misdeeds of BJP government in PM-CARES Fund which is mired in secrecy, in sale of Air India to Tatas for peanuts, about CAG’s concern about astronomical escalation in cost of construction of Dwarka Expressway from Rs. 18.2 crores per km to Rs. 251 crores per km, in the utility of more than Rs. 14,000 crores public funds for Namami Gange project while the sacred Ganga is on the verge becoming a sewer like Yamuna, and several others. The #ElectoralBondScam which points to several alleged scams, is only a tip of the iceberg. It seems further action to take it to logical end has come to a naught. Therefore, having seen the fate of investigation and trial of all the alleged scams and how the political class sabotage, it is imperative that a Special Investigation Team (SIT) comprising serving or retired officers specially chosen by the Supreme Court, which will not be part of any Law Enforcement Agency but independently directly reporting to the Supreme Court, would alone will be able to unravel the truth. It is pertinent to recall the stellar role of RTI Act and the Prevention of Corruption Act, 1988 (before it was amended in 2018) in exposing alleged corruption in the Congress-led UPA government. Information is power. So, the RTI Act empowered people to seek information from public authorities on all official matters (barring a very few exceptions). Based on that information obtained through RTI process about alleged corrupt deals, illegalities, etc during UPA rule, the CBI which had no legal shackles could initiate enquiries and investigation into those allegations. The BJP while in opposition used and exploited this situation to the hilt to oust the Congress-led UPA from power. And having formed government the BJP is acutely aware of the dangers for the corrupt lurking in these laws. So they have systematically wrecked the RTI Act so much so that it has gone from citizens’ most powerful tool to an Act on life support. In 2018 they amended the Prevention of Corruption Act, 1988. As per new section 17A introduced therein, “No police officer shall conduct any enquiry or inquiry or investigation into any offence alleged to have been committed by a public servant under this Act, where the alleged offence is relatable to any recommendation made or decision taken by such public servant in discharge of his official functions or duties, without the previous approval” of respective governments or appointing authority of the public servant. Which government will permit investigation into its own misdeeds? While Justice R. M. Lodha in 2013 denounced the CBI as a ‘caged parrot’, the BJP government translated his oral observation into a legal reality by destroying the Prevention of Corruption Act. Evidently, the real purpose of BJP undermining RTI Act and emasculating the CBI was to prevent visitation of fate similar to that of UPA by insulating and firewalling themselves from any future enquiries and investigations into their alleged corrupt deeds. Finally, there is an uncanny resemblance between the BJP’s anti-corruption rhetoric with a story in Jeffrey Archer’s popular book, ‘A Twist in the Tale’, which goes like this: Ignatius Agarbi was the new Financial Minister of Nigeria. He begins a sweep on corruption and makes a name for himself. Impressed by his extreme honesty, his president entrusted him to find out how many Nigerians have stashed their bribes in Switzerland. He arrives at the Swiss Bank with a briefcase. Despite his greatest persuasion, the Swiss banker refuses to break their code of privacy. In the end, Ignatius places a gun to the head of the Swiss banker and threatens to kill him. Still the banker refuses to divulge any confidential information. Ignatius, who was actually extremely corrupt, was only checking to find out if the Swiss Banks would actually reveal the name of an account holder. Delighted with their secrecy, Ignatius deposits $5 million in cash which he had skimmed as Financial Minister.”

M. Nageswara Rao IPS (Retired)

239,217 просмотров • 2 лет назад

Zack Polanski on BBC Radio 4's Today prog calmly knocking back everything Nick Robinson throws at him across 17 minutes NR (00:00.2), "Delighted to say that Zach Polanski is here in the Today programme studio, for the latest, indeed, for the last of our party leader interviews. Morning to you and thanks for coming in." ZP (00:09.2), "Thanks for having me." NR (00:09.8), "Nick, I want to talk to you about what your party would do if it does indeed gain some power after the votes on Thursday. But I want to begin by putting to you one of the latest storeys about you. A Times investigation says that you've made a series of false or disputed claims about jobs you've had in the past with." NR (00:31.8), "Why, for example, did you say you were a spokesperson for the British Red Cross when they are absolutely clear that, though a supporter of theirs, you were never a spokesperson for them?" ZP (00:42.3), "So I hosted, various fundraisers for the British Red Cross and indeed I would go on stage and speak for them about the amazing work they do tackling humanitarian crises, on the climate crisis and indeed for refugees all around the world. I use the wrong word and I accept that." ZP (00:57.5), "But I would essentially take words on stage with me and speak. It's important, though, and I accept this, that, you know, I don't support any political party and I've made sure that's been taken down." NR (01:06.5), "You say this sort of storey is a fuss about nothing, that you get your facts wrong because it comes up with other examples." ZP (01:11.7), "Well, I think it's totally fine to ask me questions about my past. I would also say in the same breath, though the Times published a pretty anti Semitic cartoon of me last week. I asked them to apologise. And it feels some of these storeys feel like scraping the barrel to kind of go back 10, 15 years. I've had so many friends, I'm literally talking maybe 20 or 30 in the last few weeks who have phoned me and said, a Times journalist has been phoning and they've been desperately trying, trying to find things about your past." ZP (01:36.5), "They asked me lots of questions and seemed disappointed that I didn't have some juicy, dirty gossip." NR (01:41.6), "Yeah, well, there was. Whether you call it juicy or dirty, and it wasn't gossip, it was a fact. The fact that you claimed that as a hypnotherapist, you could enlarge women's breasts using the power of thought. People are entitled to say, what's this guy really about?" ZP (01:57.2), "People are totally entitled to say that. And that's an important part of politics, that people ask you questions. What I would say is that, you know, this was 13 years ago. It was a Sun journalist's idea. I've apologised for that. Because even though it was a son journalist idea, I was an adult and I should have said no, you went along with it." NR (02:12.6), "Yeah." ZP (02:12.9), "It's important to say I wasn't a politician. And I've apologised for it repeatedly." NR (02:16.7), "And the BBC showed that some days later, in fact, you repeated the claim that you could do it. But let us not get bogged down in the past. It is striking, though, that on X last night, when, let's be honest, people who are critics of you are having a go. The Daily Mail calls it the Green Menace on its front page." NR (02:34.1), "How did you react? You said you were under relentless attacks because they, your critics don't want a wealth tax, don't want public ownership. They're trying everything in their power to stop us, you said. It's a curious thing to say, isn't it? Ahead of local elections, Green councillors will not have the power to implement any of those policies, will they?" ZP (02:54.8), "Well, I think the relentless attacks on the Green Party in this election, for a local election have partly been about the local election, but really they're about the bigger picture right now. The bigger picture is when I ran to be leader of the Green party, we had 50,000 members, we've now got 225,000 members. So we are rising." ZP (03:11.1), "And I think lots of people are worried about the prospect. And when I say people, people who own, right wing media, multimillionaires and billionaires who are worried about the prospect that they might have to pay a little bit more tax. And so I think it's important that I focus on the vision and the hope and our actual plan." ZP (03:27.4), "I also think it's a complete reality, though we've seen it in the past before with left wing leaders, that there's no secret, there's no love lost between me and the right wing media. And almost every single day they print things that just aren't true." NR (03:38.8), "But just address the point I raised. Wealth tax councils won't get to do that. Public ownership councils don't get to do that. Well, not entirely. We'll come to that in a second. You are running on a national platform of change that the people who are elected on Thursday, whether in the Welsh Parliament, you don't run candidates in the Scottish one, or in English, local councils simply cannot do." ZP (04:03.2), "Well, I think it's about what are your values as a party? And whilst other party leaders and other parties take donations from oil and gas companies or arms trade companies, private healthcare or gambling, Green Party councillors only have two vested interests and Those vested interests. We want to protect the communities we seek to serve and we want to protect the environment." NR (04:21.6), "Well, let's come to that, then, because most interesting, perhaps, is to look at what Greens say who are running for office. You are not. You are a member of the London assembly, you're not a Member of Parliament, you're not running in these elections. Now, you live in Hackney. Hackney happens in northeast London to be a top Green target for taking control from the Labour Party." NR (04:41.9), "So let's look at protecting communities. For example, on crime, the manifesto calls the Metropolitan Police institutionally racist, homophobic, sexist and misogynists. It goes on to say, greens cannot accept this system. It calls for safe spaces for, heroin users to shoot up, to end cautions for street prostitution and to end what the manifesto calls discriminatory policing of delivery riders." NR (05:08.8), "This is an agenda for an endless fight with the police, isn't it?" ZP (05:12.0), "I don't think so. Baroness Casey, in the last couple of years, did a review into Metropolitan Police and it was actually the findings that found it institutionally racist and misogynistic. Something that Sadiq Khan, the Mayor of London, to his credit, accepts. It is noticeable that Mark Rowley, the Commissioner of the Police, doesn't accept that, yet they continue, to work together in that way." ZP (05:31.1), "On the issue of drug harm, we have the highest drug deaths, of any country in Europe. And every single year for the past 13 years, drug deaths have increased. So I think the question anyone has, and we have in Hackney, is that the war on drugs has clearly failed. It's failed in cities right across this country, and more and more people are, often taking dangerous drugs." ZP (05:50.3), "So do we want people to buy them on the black market or on street corners? Or do we want people to go to a pharmacy or a medical health professional where, if they have an addiction to dangerous drugs, we can work with them to take a public health approach based in harm reduction." NR (06:02.7), "Public health approaches to. Is to legalise hard drugs and to legalise prostitution, you say to legalise and regulate and the regulators. It's still legalised, isn't it?" ZP (06:11.5), "No, the point is you can't just go into a shop and buy drugs, which is how it's presented in the press. Again, because I can keep talking about what councillors can do, rather than what" NR (06:18.3), "you would do if you were Prime Minister, because that's for another interview. Are you saying councillors should cut the police budget? Because that's what it seems to imply when you say, we cannot accept this system, let the council spend Money on crime reduction. Don't give that money to the police." ZP (06:33.7), "It's about reprioritizing. So it's." NR (06:35.5), "Does that mean cut in English?" ZP (06:36.7), "No. So let's look at example. We're straight back onto drugs. A lot of police time is spent on stop and search for cannabis use, for instance. It doesn't escape people's notice that that is often, in the politics of racism, if you're a young black person, I think it's something like you're 18 times more likely to be stopped and searched than your white peer, despite the fact there's no evidence that they're more likely to be dealing or using drugs." ZP (07:00.8), "And so I think it's important that we make sure the police time is spent properly, which I think is about community prevention, about cohesiveness and bringing communities together, particularly in, like, whether it means redirecting the budget." NR (07:11.4), "Does it mean the police budget?" ZP (07:12.9), "Well, it means redirecting within the police budget, so making sure that the time police are spent is spent on community safety." NR (07:18.2), "Well, it's interesting that we talked about police because, as you know, you've come under serious criticism for retweeting criticism of the action of the police officers who stopped the alleged attacker of Jews in Golda's Green. Now, you apologised for retweeting that." NR (07:34.1), "You said you should have a meeting with the head of the Met. You sent him a letter. I want to ask you a different question. You've not apologised for the content of that. Why did you empathise with the attacker, and not with police officers who feared for their own lives and were trying to protect other people's lives?" ZP (07:53.3), "I think there's two things in that that I, really clearly want to say. The first is my very first response to the attack was to be horrif, as everyone was, I'm sure. And the first thing I posted was solidarity to the victim, to the family and indeed, to people who are suffering right now, including as a Jewish man, where Jewish safety is not abstract." NR (08:12.0), "But then you posted that officers were repeatedly and violently kicking a mentally ill man in the head when he was incapacitated by a Taser, caused extreme offence to those officers, to the head of the Met and to many people. I ask you again, why did you empathise, Empathise with the attacker, not with the police officer." ZP (08:28.9), "As I said, there's two things I wanted to say, so that was the first. The second, what I want to say is two things can be true at the same Time officers are incredibly brave when they run towards scenes of crimes that most people, including myself, would want to run away from. At the same time, I think it is accurate, and that I was also traumatised, by seeing, someone handcuffed and completely, repeatedly kicked in the head." ZP (08:51.7), "Now, sure, if you'll forgive me, it is an answer," NR (08:54.4), "but it's not an answer to the question. You posted something with the power that you have, with the number of people who follows us, and not empathising in that post with the Jewish community or critically with the police officers, you empathise with the attacker. Look what they're doing to the alleged attacker." ZP (09:11.1), "I don't think it was your choice. As I say, the first thing I did was show solidarity to the victims and I thank the officers. Second, though, I think the sign of a compassionate society is how we treat people, even people who have done horrific things, because actually, the way we do justice in this country is in court." NR (09:26.0), "You said a key value of the Greens was protecting communities. What are your proposals for protecting the Jewish community?" ZP (09:33.5), "The Jewish community is not safe right now. And as I said, as a Jewish man, this isn't abstract for me. In fact, in the last six weeks alone, two people have been arrested. So how would you protect anti Semitic attacks towards me? I think there's lots that needs to happen in this country. The first is community cohesion and community building. Some of the work that I'm proudest of in London, that I see Londoners do, is where I see the Jewish community working alongside the Muslim community." NR (09:55.1), "What would you do? What would Zach Polanski do in order to reduce attacks on the Jewish community?" ZP (09:59.9), "So, first of all, to invest in that work, that community, faith work, to make sure communities stand together. Second, to make sure that the Jewish community, give them the investment that they need. In fact, what the Prime Minister has been doing to make sure that happens. I do think a police response is the last response when everything before it has failed." NR (10:17.6), "I still think you're not really answering the question about what you would do. Let me ask you this." ZP (10:21.0), "I think I do." NR (10:21.6), "Would you deal with, for example, a candidate who says Jewish people fear hate because they know they should be hated. Another one who suggested that the attacks on the ambulances was a false flag and carried out, presumably by Israel. Another of your candidates who blamed Israel for the Bondi beach terrorist attack." NR (10:41.0), "A fourth candidate who said Donald Trump was, quote, owned by Jews. And most horrifying of all, although this individual has now been arrested, one of your candidates who Reposted something saying ramming a synagogue isn't anti Semitism, it's revenge." NR (10:56.8), "What are you, Zach Polanski doing to end these disgusting messages?" ZP (11:03.5), "Those messages are all unacceptable and it's important to condemn that. The Green Party are an anti racist party and it's important that we stick to our values." NR (11:11.0), "We can't just say the words were an anti racist bar to. And I've just read you out five of the most revolting comments at a time when, according to an independent advisor, we face a national emergency of anti Semitism. I'm asking you, you're not responsible for everything they say. Of course you're not." NR (11:26.3), "You can't be." ZP (11:27.3), "I am responsible, actually." NR (11:28.2), "What are you going to do about it?" ZP (11:29.0), "I am the leader of a party. I was about to finish my sentence." NR (11:31.5), "Forgive me. Go on." ZP (11:32.4), "We're an anti racist party. And so what I've already committed to doing is making sure that we have a standardised vetting process in future. And also make sure that we have compulsory training of all our candidates to make it clear that anti Semitism is completely unwelcome in the Green Party as it is in society. It is also important to say one case of anti Semitism is one too many." ZP (11:50.5), "This is a handful of cases and actually we have over 4,500 candidates, the vast, vast majority of which are doing amazing work in their communities right now, going out there to tackle the cost of living crisis, to make sure that we're funding public services and making sure that it's about people power and community, grassroots power." NR (12:05.1), "You can dismiss one or two as, just, unrepresentative. I've just read five. I could have read 20 cases of revolting anti Semitism posted by your candidates. Now you're a new leader, how are you going to avoid becoming the new Jeremy Corbyn of British politics?" ZP (12:21.5), "Well, I think me and Jeremy are very different people and there's much, you know, the question was almost inviting me to condemn Jeremy Corbyn. I think there was lots that Jeremy Corbyn was putting forward to this country that I think was really positive. We've talked about wealth taxes, about public ownership. I also think it's important, speaking, for myself right now, that we make sure that we have this vetting process, that it's really clear that anti Semitism, Islamophobia, any form of hatred or hate, crime is not welcome." NR (12:47.3), "Do you believe that Palestine is, to coin a phrase, on the ballot this Thursday?" ZP (12:52.3), "I think lots of things are on the ballot this Thursday." NR (12:54.6), "But is Palestine on the ballot? This." ZP (12:56.2), "I think it's one of the elements, as is the climate crisis. As is." NR (12:58.7), "What does it mean Palestine is on the ballot? Because. The reason I ask you is because your candidate for mayor of Lewisham says Palestine is on the ballot this Thursday. Haringey Green Party campaign launch video. You might think it'd be about bins, you might think it'd be about schools, hospitals, it might be about cleaning up the roads." NR (13:17.2), "It is a series of councillors saying, as a council, I will take all appropriate steps to, uphold the inalienable rights of the Palestinian people. Do you think council elections really should be about Palestine?" ZP (13:29.8), "I think they can be about all of those things. And I think what people have seen in this country is a genocide for two and a half years that our government is still arming, are still sharing intelligence with. And I think lots of people feel very strongly both about their local services, as they should do, and feel equally strongly about the fact that there's a reprehensible genocide happening." ZP (13:48.5), "And they vote, but the way they vote in local elections" NR (13:52.6), "should be determined by their views of Israel and Palestine." ZP (13:56.0), "I wouldn't tell anyone how their vote should be determined, but I think it's an element for lots of people in how they vote." NR (14:00.1), "And do you think that will contribute to community cohesion? Do you?" ZP (14:02.7), "I think yes, because I think, we shouldn't pit Jewish safety against a genocide in Gaza. That's conflating anti Semitism and criticism of the Israeli government. That's something Benjamin Netanyahu does regularly. And as a Jewish person, that makes me feel less safe." NR (14:16.4), "Sure. But there are lots of Jewish people who would say to you they feel unsafe if they feel that their counsellors are motivated first and foremost by Palestine. And if somebody gives that speech, for example, about Palestine being on the ballot, they are likely to think that." NR (14:34.6), "We looked for, example at Barnett Greens, where one in seven residents identify as Jewish. And it includes in its manifesto the fact that, you're standing up for Palestine. Do you think that's going to help?" ZP (14:49.0), "Well, I walk regularly on Palestinian marches with hundreds and hundreds, in fact, thousands of people, many of whom are Jewish. And there have been rabbis who have spoken out on this too. I accept, though, there are Jewish people whose views are equally as valid who, don't agree with those views." ZP (15:04.0), "And I think the job of all of us who are in public life right now is to de. Escalate tensions. And look, how do we bring people together? And I accept that's a huge challenge. And I think one of the ways we could do that is by ending our complicity in the genocide." NR (15:15.4), "Let's turn finally to another issue. We'll talk at greater length when, we're talking about the possibility of you being Prime Minister, which you have said that you would like to do. One thing that is very high on the agenda now is the soaring cost of government borrowing. What would the Greens do to cut it?" ZP (15:30.6), "Well, I think we need to make sure that we're investing. So I think there's two ways of doing that. The first is, wealth taxes, which I know we've rehearsed before, but I'll just say that's for first place." NR (15:38.4), "How does that cut government borrowing?" ZP (15:40.2), "Because ultimately it means you need to borrow less if you're." NR (15:43.0), "If you're ultimately about cutting the cost of government borrowing." ZP (15:45.5), "Yes." NR (15:45.8), "Which is soaring. It's higher than it's been any time this century because people are nervous about high spending, high taxing governments that are politically unstable." ZP (15:54.7), "I think someone who speaks brilliantly on this, who I've spoken to, is the economist Mariana Matsicatu, and she talks about the fact that a government should have a mission that should be a very clear plan of how you tackle the climate crisis, how you reduce inequality. Now, if you have a clear plan and you're borrowing for that, you're taking the market with you because they can clearly see what the return on investment is and how you're bringing money back into the." ZP (16:15.2), "That's how you reduce borrowing levels. If we don't have a plan and continue to borrow, then it feels very, very scattered, and that's why things are getting worse. We need to make sure that there's a consistent plan in place that's set out carefully that can make sure we're putting money back into our communities and investing in those communities." NR (16:29.3), "Do you think you're ready to be Prime Minister?" ZP (16:31.1), "I'm not ready right now, no. I've been leader for eight months, and there's lots of skills and lots of knowledge to get, and I think that's fine. I think I'm a human being. I'm not perfect." NR (16:38.5), "But give it two years, you will be." ZP (16:40.0), "Well, we'll see in two years time, won't we? But I'll certainly be putting in the work." NR (16:43.2), "Zach Polanski, leader of the Green Party in England and Wales, thanks very much for coming into the." ZP (16:46.3), "Thank you, Nick."

Farrukh

167,874 просмотров • 4 месяцев назад

An interview by VERY DARK AND CORRUPT Wall Street Journal aired today [1] WSJ's terrible "journalists" (and I use that term lightly) made many false statements about Sarepta's worthless, dangerous drug and Vinay Prasad's firing [1,2] I explain how the FDA sausage is made in excruciating detail Buckle up To get readers up to speed -> In June, corrupt pharma company Sarepta Therapeutics paid $40,000 to lobbying group Michael Best Strategies (MBS) to deal with a problem [3] -> MBS had recently hired Chris LaCivita, who had close connections with "MAGA" influencer Laura Loomer [4] -> With stock down 88%, Sarepta needed to sell their very bad, very dangerous drug or the company would go bankrupt [5] -> After several deaths from the drug this year, FDA official Vinay Prasad said "no way" and kicked the drug to the curb [2,6] -> Sarepta panicked and paid MBS (we believe) to deal with Prasad [3,4] -> If this story is right, LaCivita recruited Laura Loomer to take down Prasad [4,7] -> Loomer said she was defending Trump, but she was lying [7] -> She was defending taxpayer-funded payouts to a worthless, corrupt company [7] -> Laura Loomer so brave A history of bad drugs and regulatory failure -> This is one of the worst pharma scandals in American history and corrupt mainstream media isn't covering it -> Sarepta has a very long, troubled history [8] -> For more than a decade, every major Sarepta FDA drug approval has required INTENSE political intervention [8,9] -> Scientists at FDA have been repeatedly overruled [8,9] -> Many scientists have resigned, very publicly, over these POLITICAL decisions, some writing scathing public criticisms of these terrible decisions [10,11] -> The most recent resignation by Vinay Prasad is not something new; it follows in a long tradition [2,10] -> In fact, standards have dramatically deteriorated since the first controversies about the company's drugs in the 2010s [8,9] -> Prasad was trying to hold the line in the face of rapidly deteriorating standards at the agency [2,6] -> For that, pharma launched a coup--a literal coup of a drug regulator [4,6] -> This is unprecedented -> Banana republic sht, unbelievably corrupt 2016: first Sarepta drug approval and the "highly unusual" decision -> The first Sarepta drug approved by FDA was called Exondys 51 [8] -> This drug was for patients with mutations in dystrophin, a muscle protein [8] -> This is a debilitating and fatal disease affecting children [8] -> Exondys 51 increased dystrophin by 0.2% of normal levels [8,12] -> Unsurprisingly, there was no good evidence the drug worked [8,12] -> Why would it? It increases the protein from zero to 1/500th of normal levels -> One reviewer wrote: "I can find no precedent of an accelerated approval for a marketing application where the effect size on the surrogate endpoint is as small as 0.3%." [12] -> The study submitted by the company included no proper control group [12] -> The techniques used were so bad not even a first-year PhD student would do a study that way -> This the level of work you would expect from a mediocre undergraduate with no guidance -> It's almost like it was so bad on purpose -> (Narrator: it was on purpose) -> Nerd time: -> One reviewer wrote: "The Western blots submitted by the applicant for Study 201 were oversaturated, unreliable, and uninterpretable." [12] -> Another wrote: "Because CDER also determined that the conditions under which the original IHC analysis was performed were inadequate, including that the reader was not masked to sequence and time, the Center requested a re-reading of the stored images by three masked pathologists under different conditions. The IHC results from the reread were not nearly as favorable, as compared to the initial IHC results reported by Sarepta." [12] -> "The lack of concordance between the IHC and the Western Blot results is 'striking'" [12] -> "Study 201/202 had fundamental flaws, including baseline biopsies from external controls who could differ in unknown ways from study subjects, Week 180 biopsies from different muscles than baseline, and potential protein degradation in stored baseline samples." [12] -> And on and on. -> FDA commissioner Robert Califf wrote at the time: the submitted study was "characterized by major flaws in the clinical study design" and "Blinded experts assembled by the FDA fundamentally debunked this study, which has yet to be retracted and continues to be cited" [9,12] -> That's right, the FDA commissioner expressed dismay that the study that the company used to gain approval hadn't yet been retracted, it was so bad [9] -> Senior FDA official Janet Woodcock decided to approve before scientific review team had even voted [9,12] -> Woodcock be like: yeah i'm going to decide before you guys can because i know what you're going to say lol -> Despite external intense pressure, FDA scientists voted against Exondys 51's efficacy [9,12] -> They then voted against its accelerated approval [9,12] -> The review team filed an appeal with FDA commissioner after "passionate" disagreement with Woodcock [9,12] -> One reviewer called Woodcock's decision "unprecedented" [12] -> In a 126-page report, FDA commissioner Califf called Woodcock's decision "highly unusual" [9] -> The FDA board wrote: "[Woodcock's] involvement here appears to have upended the typical review and decision-making process. ... Care should be taken to avoid the appearance of interfering with the integrity of scientific reviews at the lower levels of a Center." [9] -> Again, the data were unbelievably bad, literally every technique in the study was inappropriately used [12] -> I would fire an undergraduate student who did science like this, immediately -> FDA's chief scientist accused Sarepta of "serious irresponsibility" for selectively publishing only some of the data [9] -> Even Woodcock, who approved the drug, called the research "seriously deficient" [12] -> Yes, even the person who approved the drug over the heads of FDA's scientists said the research was horrible [12] -> Still, FDA tried to bury their heads in the sand and beg that, basically, Sarepta pretty please do a better job next time -> FDA commissioner: "The utmost attention should be paid to optimizing the methodological rigor of [future] trial[s]" [9] -> FDA also demanded a clinical trial "to verify the benefit" of the drug [8] -> Welp, this was in 2016 [8] -> The trial results are supposed to be available in 2026, maybe [13] -> Or maybe later, depending on how much money needs to be made first -> As an article published in Nature three years later despaired of the decision: "The approval was conditional on the company agreeing to conduct a two-year post-approval trial to show Exondys 51’s efficacy. But by August 2019, the company had yet to begin such a trial and in the meantime had profited from sales of $300 million in 2018." [13] -> If it sounds like Sarepta used political pressure to get its drug approved and then tried to avoid actually publishing the study showing it didn't work, it sounds that way because that's exactly what happened [13] -> FDA commissioner after deferring to Woodcock: "I am confident this unique situation will not set a general precedent for drug approvals under the accelerated approval pathway, as the statute and regulations are clear each situation must be evaluated on its own merits based on the totality of data and information." [9] -> This statement was profoundly naive, and the historical record bears this out [8,14] -> Three FDA scientists resigned, including the lead reviewer of the drug, understanding the grave implications of the collapse of scientific standards and where they would lead [10,11] -> One was John K. Jenkins, M.D. Director, Office of New Drugs Center for Drug Evaluation and Research/FDA [10] -> In a presentation given just before his resignation, he wrote: -> "Path taken by Sarepta NOT a good model for other development programs" [10] -> Crucially: -> "Upholding statutory standards for approval in face of hopes and desires of patients, families, sponsors, and investors is a very difficult job" [10] -> "Personal attacks on FDA reviewers creates an atmosphere of distrust and isolation rather than collaboration" [10] This brings us to WHY Sarepta's drug was approved Facebook FDA -> So why did the drug get approved? -> Basically, Sarepta propagandized extremely desperate patients [9,15] -> They used miraculous snake oil promises and patients believed them -> Remember that this is life or death for patients, and they are extremely vulnerable -> Sarepta also professionally trained some patients to give testimonials to FDA and congress [15] -> The patients then went to congressmen who don't have time to understand the science [15] -> They gave emotional stories to congressmen [15] -> The result: -> Letter from 109 House members [15] -> Letter from 24 Senate members [15] -> And a media circus documented in the New York Times [16] -> Patients screaming at scientists during meetings [9] -> 2,792 emails written to FDA urging approval [12] -> One of them: "Dear Dr. califf: How is it that everyone in and around DMD understands this simple Idea and the science geniuses at FDA don't? You stupid fckers are costing each and every DMD kids days of their lives with your Moronic Dystrophin dance. Time to get a fcking clue" [12] -> Upon approval, a journalist for Reuters wrote: "owing to pressure from patient advocates, the U.S. Food and Drug Administration on Monday approved a treatment for Duchenne muscular dystrophy even though an outside panel of experts and the agency's own reviewers questioned the drug's efficacy" [17] -> A commentary in Nature Medicine was also published called "Railroading at the FDA" [9] -> Its author wrote: "In the words of one FDA committee member, Exondys lowers the agency's evidentiary standard for drug effectiveness 'to an unprecedented nadir.'" [9] -> A highly critical commentary was also published in Science, titled "Sarepta gets an approval - Unfortunately" [18] -> The article's author pharma veteran Derek Lowe wrote: "The company... called up Duchenne-affected boys and their families to plead with the FDA, and won over Janet Woodcock, and that appears to be enough. Is this going to be the new way to get a drug approved? Run a trial in a dozen people, generate unconvincing data, and then lobby Janet Woodcock? I share the worries that this might open the floodgates, because after all, Sarepta got their drug through." [18] -> One FDA reviewer ended in an equally grim note: ". Approval of this NDA would send the signal that political pressure and even intimidation – not science – guides FDA decisions, with extremely negative consequences. The public is well aware of this development program: the meager size of the study population, the marginal (at best) effect size, the Division’s dim view of the efficacy data, and the robust activism of some members of the DMD community. Many would be amazed at an approval action, because other DMD drugs, recently turned down for approval, appeared to provide stronger evidence of efficacy. ...The ramifications here are profound. The public will perceive that it was their unprecedented lobbying efforts that made the difference and earned eteplirsen its accelerated approval. For the future, this will have the effect of strongly encouraging public activism and intimidation as a substitute for data, which is one of the worst possible consequences for communities with rare diseases. This type of activism is not what was envisioned for patient-focused drug development." [12] -> A new era was born -> Activism had replaced data -> Facebook had fried people's brains -> And now Facebook-fried brains had fried FDA too -> FDA's credibility as a regulatory agency would now be hollowed out -> FDA's Facebook age had begun -> But the worst was yet to come Sarepta approvals: 2016 to present -> Three more drugs were approved from Sarepta on the same shoddy basis, proving Califf's promises that Exondys 51 was an isolated case empty [8,14] -> But things would take a turn for the worse with Sarepta's newest drug Elevidys in 2024 [19] -> At last a rigorous clinical trial looking at actual clinical outcomes was published [19,20] -> All would be put to rest -> At long last the issue could be resolved with HARD CLINICAL DATA -> There was only one problem -> The trial failed to show any benefit according to the primary outcome [19,20] -> The surrogate biomarker of micro-dystrophin meant absolutely nothing; it wasn't actually helping patients [19,20] -> What did FDA scientists do? They voted against approval. Of course [19] -> How could they not? The drug didn't actually work in the clinical trial [19] -> It's the only thing that made sense, since FDA is a scientific agency -> AND THEY WERE OVERRULED AGAIN BY PETER MARKS [19] -> YES THAT'S RIGHT, OVERRULED YET AGAIN -> PHARMA WINS AGAIN -> HAHAHAHAHAHA PHARMA ALWAYS WINS YOU FOOLS -> What happened is that Marks crossed his eyes somewhat, trying to make the words on the page blurry -> He prayed really hard, "my god please give me a sign, something, anything, I need this for my career" -> lzzosolsolzzolzozlslzolosllslozllzlzl -> Marks was trying really hard to see SOMETHING, come on come on, give me SOMETHIGN he said -> And he said: wait, look, there are these secondary, exploratory endpoints and a two of them look pretty good, I'LL APPROVE [19,20] -> AHAHAHHAHAHA YES PHAMRA WINS AGAIN -> And Marks said, "Thank you pharma go- I mean god, not pharma god, why did I just say that, FCK" -> The trial was explicitly designed for what Marks did NOT to happen [20] -> Once the primary endpoint was not met, the secondary endpoints couldn't even be statistically tested [20] -> And the trial explicitly said that they could not be interpreted the way Marks interpreted them [20] -> They were not adjusted for multiplicity and they were, like expression of dystrophin, simply bad endpoints [20] -> These two secondary endpoints were time to rise from lying on the floor and the 10-meter walk/run tests [20] -> Subjects who received the Elevidys performed, on average, about 0.5 seconds better than placebo recipients on these tasks [20] -> However several facts must be borne in mind when interpreting these: -> 1. At the time of testing, patients receiving the drug were receiving more corticosteroids than placebo patients, biasing the results [20] -> 2. Blinding might have been broken because those receiving the drug experienced lots of nausea and vomiting from the drug (~70%) [20] -> 3. These differences were tiny and may be attributable to chance, since the natural course of the disease varies widely [20] -> Marks knows this but who cares? Pharma I mean Facebook needed to be placated Elevidys: the drug -> To understand why this is so messed up, one must understand a few things -> On a Bayesian basis, one must assume that Elevidys is harmful until proven otherwise, for two reasons: -> 1. All drugs are potentially "toxic", but some toxins heal: by default you must assume it is a toxin that does not heal because this is what is actually usually the case; you need evidence that it actually heals -> 2. Elevidys IN PARTICULAR must be assumed to be harmful until proven otherwise because of the very nature of the drug -> Let's do a breakdown of the basic science of Elevidys that supports this (Bayesian) hypothesis: -> Gene therapy that permanently integrates into human genome [21] -> Meant to replace dystrophin, the protein that these patients cannot produce themselves [21] -> Preferentially targets muscle but gets expressed everywhere [21] -> Killed three people this year [6,21] -> Costs $3.2 million per injection [21] -> Truncated version of the protein it is supposed to replace [21] -> 3X shorter than the real protein [21] -> Has to be truncated because the technology cannot create the full protein [21] -> Because it's an abnormal protein, it's foreign, so immune system attacks it [21] -> Patients injected with drug are basically given an autoimmune disease [21] -> Patients have to be given anti-inflammatories to fight the disease that the drug causes [21] -> Causes terrible muscle inflammation [21] -> Inflames the heart, heart walls thicken because of the inflammation [21] -> Blows up the liver, causes acute liver injury and death [21] Drug should actually be assumed harmful, not beneficial -> Given all of the above, since the drug failed to meet its primary endpoint, it should actually be considered harmful by default, not beneficial [19,20] -> In other words, what we would actually expect if we added more patients and did an even larger study... -> Is that the drug would do worse than placebo, i.e., patients taking the drug would do worse than those taking placebo -> Why isn't this the default interpretation? -> They are reading the study with an intervention bias -> An intervention bias is natural, which is why "do no harm" is such a central tenet of medicine -> If I may put forward a thesis: most of Vinay Prasad's 500+-paper body of work has been dedicated to demonstrating the "do no harm" principle empirically [22] -> Rose-colored glasses study interpreters are simply not applying this principle properly and are thus failing scientifically in the most fundamental way -> Incomprehensible -> Back in 2016, scientists were adamant that the approval of Sarepta's first drug indicated the profound deterioration of scientific standards [8,9] -> But this latest approval is even worse: actual clinical data is now being overruled -> No standards at all are being enforced anymore; anything can now be approved based on any evidence whatsoever -> What Vinay was trying to do was simply to stop the unrelenting downslide -> And his firing punctuated that downslide for what it was The WSJ segment -> When Elevidys was approved, former FDA chief scientist and one of the original reviewers of Sarepta's first drug Luciana Borio said: -> "I don’t know what to say. Peter Marks makes a mockery of scientific reasoning and approval standards that have served patients well over decades. This type of action also promotes the growing mistrust in scientific institutions like the FDA." [23] -> To return to this video, these two WSJ reporters show an incredible level of ignorance and arrogance -> Finley says that the drug is "clearly" beneficial by misreading the secondary endpoints, just like Marks did -> An FDA memo from last year says about these endpoints: "Under these circumstances, they are misleading and cannot guide any stakeholders—including patients, family members and caregivers, and prescribers—in making informed decisions about the potential benefit of treatment with ELEVIDYS." [20] -> It really doesn't get any clearer than that -> But these two journalists are overruling the actual scientists, just like Marks did -> One of the most incredible comments during this interview was the complaint that "90% of clinical trials fail", as if that's bad thing [1] -> It's actually a good thing; most drugs suck; failing in clinical trial actually allows us to use only the drugs that don't suck -> These people don't understand the most fundamental purpose of the clinical trial -> They think clinical trials failing is a bad thing, as if it means that patients now won't get to use a useful drug -> No, it's a good thing, because it means that patients won't be exposed unnecessarily to a useless drug that might harm them -> The level of ignorance really is unbelievable -> What's worse is that these "journalists" defend their decision -> But what they did is exploit social media hysteria caused by Laura Loomer [1,7] -> Following up on her heels with editorials, using her as pharma attack dog [1,4] -> This is a huge blow to WSJ's credibility, and they know it -> Unbelievably shameful Where do we go from here? -> The Vinay Prasad firing creates a serious crisis of credibility at FDA [2,6] -> Up to this point, we could call these approvals a difference of opinion, but as we've seen, that's a huge stretch -> But any illusion of that is now shattered: the firing shows that drug regulation is explicitly political -> Janet Woodcock: approve, keep job -> Peter Marks: approve, keep job -> Vinay Prasad: block, transparently fired -> Make a decision that is anti-pharma and lose your job: that's the message -> Who can trust any decision at FDA anymore? -> RFK Jr. and Marty Makary both stand behind Vinay Prasad [24] -> Trump went along with lockdowns, he went along with mask mandates, he went along with all of the Covid pseudoscience that he now decries -> He should reverse course and not go along with this -> Trump has created a profound crisis of credibility at FDA and needs to fix it

Kevin Bass

80,314 просмотров • 1 год назад