An ongoing randomized controlled clinical trial (RCT) to test the role of Hydroxychloroquine (HCQ) in the treatment or prevention of COVID-19 was prematurely halted by the British scientists by calling it “Useless” as they found no evidence of any positive effects of this anti-malarial drug against the coronavirus (see below). The US Food and Drug Administration (FDA) also issued a strong “warning” to all doctors planning to use HCQ to treat COVID-19 patients about serious and potentially life-threatening adverse effects of HCQ including increased rate of heart failure and death. PBT also moved a public interest litigation (PIL) in the Supreme Court seeking implementation of life-saving precautionary measures and mandatory “informed consent” before Indian hospitals and doctors start using HCQ on vulnerable COVID-19 patients as touted by the Indian Council of Medical Research (ICMR). The Apex Court disposed of the said PIL with specific direction that ICMR should consider the points raised in PBT’s PIL. Unfortunately, ICMR has not responded to PBT’s repeated requests seeking what steps, if any, they have taken to protect the COVID-19 patients who are being treated with the potentially dangerous and unproven HCQ. PBT also sent a legal notice to ICMR and Ministry of Health & Family Welfare last week that unless they provide satisfactory response to the use of HCQ in COVID-19 patients, PBT will have no other option but to move the court of law once again.

Med. Dialogue-UK (Jun, 2020) COVID-HCQ

“Rogi Divas” (“Patients’ Day”) will be observed, like previous years, to commemorate the death of all victims of medical negligence including the death of Anuradha Saha (who died on May 28, 1998 due to gross medical negligence by several top Kolkata doctors) and to empower the Indian patients and their families who have been suffering and paying heavy price, sometime with their lives, to the hitherto “untouchable” and enormously influential doctors and hospitals. Each year on May 28, PBT hold public rallies to celebrate “Rogi Divas” but due to the ongoing COVID-19 crisis, no public meetings will be held this year. PBT requests all victims of malpractice and conscientious citizens of India to commemorate the loss of innocent lives due to reckless practice of medicine by a part of the devious doctors and greedy commercial hospitals and to come forward and raise voices against medical negligence and healthcare corruption by joining hands with PBT. Contact PBT head office in Kolkata at 9831983670 or 8240209992 for more information.

Two separate studies published in the latest issue of the top international medical journal, British Medical Journal (BMJ), finds that there is absolutely no benefit for COVID-19 patients in different stages of the disease who are treated with the anti-malarial drug Hydroxychloroquine (HCQ). While a large study from China with patients with mild to moderate symptoms of COVID-19 showed difference in the outcome whether treated with or without HCQ, a separate study by researchers from France with COVID-19 patients in severe condition with pneumonia also showed absolutely no benefit from HCQ. In fact, this study reported adverse cardiovascular side-effects in the group that was treated with HCQ. An editorial entitled “Lack of efficacy of Hydroxychloroquine in COVID-19” published in BMJ today (May 19) discussed these two latest studies and the apparent lack of any effect of HCQ for COVID-19 patients (see below, also available at the link: https://www.bmj.com/content/bmj/369/bmj.m2018.full.pdf). The BMJ also carried online an analysis (“Rapid Response”) by PBT president, Dr. Kunal Saha, on the continued irrational use of HCQ in COVID-19 putting the lives of COVID-19 patients at potential danger of developing heart failure or sudden death as warned by major international cardiac societies as well as the US Food and Drug Administration (FDA) (see Dr. Saha’s article below, also can be viewed at https://www.bmj.com/content/369/bmj.m1844/rapid-responses).

PBT already lodged a PIL in the Supreme Court seeking direction to the ICMR to implement precautionary measures for COVID-19 patients treated with HCQ to prevent injuries or death as a result of unproven HCQ therapy. The Apex Court directed the Solicitor General to place the PIL before the ICMR for consideration. Earlier this last week, ICMR sent an evasive response without taking any effective measures and PBT has written back to ICMR asking them to take concrete steps to protect COVID-19 patients treated with “off-label” HCQ.

BMJ (May 19, 2020) Rapid Response K. Saha

BMJ Editorial (May 19, 2020) HCQ-COVID

In response to PBT’s PIL and direction from the Supreme Court of India about “off-label” use of unproven anti-malarial drug, Hydroxychloroquine (HCQ) and antibiotic Azithromycin (AZM), assistant director of the Indian Council of Medical Research (ICMR), highest authority to regulate treatment of COVID-19 in India, sent a letter dated 16th May, 2020 to answer PBT’s concerns for widespread use of HCQ and/or AZM in COVID-19 patients that many recent scientific studies have shown that it can cause serious adverse effects resulting increase in heart failure and sudden death (see ICMR letter below). In its PIL before the Apex Court, PBT had sought that based on the recent reports about HCQ/AZM, treatment guidelines issued by ICMR must include essential precautionary measures to protect the vulnerable COVID-19 patients and doctors must obtain valid “Inform Consent” from the patient/patient’s family before starting the experimental HCQ/AZM therapy after full disclosure of the potential dangers of these drugs to the patient/patient’s family.

Although ICMR appears to have agreed that consent from the COVID-19 patients may be necessary before putting them on with “off-label” HCQ/AZM, ICMR has made an astonishing claim that all COVID-19 patients have automatically given an “Implied Consent” when they are treated in Indian hospitals following the published “Treatment Guidelines” because somewhere in these guidelines a generic statement exists to “Communicate early with patient and family”. Supreme Court of India has defined “Informed Consent” in numerous decisions including the landmark judgment in Samira Kholi vs. Dr. Prabha Manchanda & And. (2008 SCC 2, 1) in which the Apex Court has categorically held that doctors must obtain “informed consent” before any treatment or surgery after explaining full details about all pros and cons, especially risks involved and other treatment options available, in regard to the new therapy. It is astounding that the highest medical body in India (ICMR) feels that all COVID-19 patients have automatically given “Implied Consent” to be subjected to any experimental therapy without their knowledge about the risks involved in the experimental drugs. PBT has already submitted a rebuttal-response to ICMR’s outlandish letter and demanded immediate clarification and appropriate action in regard to the experimental and potentially dangerous treatment with “off-label” HCQ/AZM.

ICMR Response-Hydroxychloroquine (May, 2020)

It was widely reported last month that large number defective kits from China to test COVID-19 were supplied to many laboratories in West Bengal and other states by Indian Council of Medical Research (ICMR) producing many “false negative” results to detect the coronavirus, SARS-CoV-2. False negative test results not only give false low number of infected patients, it will obviously also cause more spread of COVID-19. In fact, ICMR withdrew these spurious test kits after many state governments raised objections, virtually admitting that the Chinese kits they procured to test COVID-19 were substandard. But the crucial question that ICMR must answer is why they procured defective kits from China and how this problem was not detected until the substandard kits were supplied to laboratories across India and produced large number of “false negative” results?

PBT wrote to World Bank president last month about this potentially enormous corruption with spurious COVID-19 test kits and asked World Bank for a full investigation of this sordid incidence and exemplary punishment for the individuals involved with this alleged corruption because World Bank provides substantial funding to combat COVID-19 in India. In a letter dated May 6, 2020, World Bank Country Director in India, Mr. Junaid Kamal Ahmad, has stated that they have transferred PBT’s complaint against the allegedly defective test kits for COVID-19 to ICMR because the procurement of these kits did not involve any World Bank financing (see PBT’s complaint and World Bank response letter below). We will keep a close watch on this fiasco with COVID-19 test kits and hope that ICMR and other Indian authorities will take immediate measures to investigate and bring justice to all the people responsible for this massive failure to test COVID-19. Ironically, PBT president Dr. Kunal Saha, was hired by the World Bank as an HIV/AIDS specialist, to investigate similar allegations of bogus HIV test kits across India in 2007-2008. The final report of this investigation by World Bank published in 2009 found widespread corruption with HIV test kits. A criminal case was started in 2006-2007 by Indian authorities against several individuals from Monozyme India for supplying thousands of spurious HIV test kits that perhaps resulted in transmission of the deadly HIV to countless innocent patients through tainted blood. Unfortunately, these criminal cases have remained in a deep slumber till now showing unthinkable travesty of justice. PBT also moved several PILs against National AIDS Control Organization (NACO) in High Court and Supreme Court of India.

World Bank Response (May, 2020) COVID kits

Let to World Bank Presient (Apr. 27, 2020) COVID-India

Dr. Pradip Kumar Mitra, retired director of Institute of Post-graduate Medical Education & Research (IPGMER) and SSKM Hospital, premier state-run super-speciality medical center in Kolkata, was recalled this week and posted as the chief “Coordinator” for the Management and Containment of COVID-19 Pandemic (MCCP) by West Bengal government. Dr. Mitra has a grossly tainted background as he was directly involved in hatching a dangerous plan, along with two other highly influential doctors, Trinomool MLA and W.B. Medical Council president Dr. Nirmal Maji and Dr. Rajendra Pandey, to perform a pet dog’s dialysis using the dialysis machine at SSKM hospital in 2015. Although this horrific “dog dialysis” eventually did not materialize as the secret plan was leaked at the last moment resulting in huge public uproar and media frenzy, the reckless idea to perform a dog’s dialysis using the machine used by numerous human patients everyday underscored the outrageously unethical mindset of the the three doctors including Dr. Mitra.

PBT raised strong protest and lodged a formal appeal with the Medical Council of India (MCI) seeking disciplinary action and cancellation of medical registration of the three accused doctors. After a long and arduous investigation, MCI passed a final order last year holding all three doctors guilty for hatching the plan of dog-dialysis at SSKM Hospital and deemed their act as strongly “condemnable”. However, considering that the actual dialysis of the dog did not happen, MCI issued a warning against the three doctors including Dr. Mitra (see MCI Order below).

We are shocked to see that the same Dr. Mitra who has shown absolutely no moral character who did not hesitate to indulge into reckless medical act putting the lives of the innocent patients at serious peril by planning a dog’s dialysis at the SSKM Hospital, now chosen to the top post to combat the ongoing COVID-19 pandemic in West Bengal. Two other highly tainted doctors, Dr. Sukumar Mukherjee who is well known for his reckless and negligent act causing death of Anuradha Saha as held by the Supreme Court of India and an American doctor, Dr. Thomas Frieden who was arrested by New York police and pleaded guilty for sexual assault in 2018, were also included in Mamata Banerjee’s so-called “Global Advisory Committee” to regulate COVID-19 for Bengal residents. PBT has filed a formal appeal today with the West Bengal Governor to step in and take immediate measures for removal of the tainted doctors from the powerful committees in charge of controlling the COVID-19 pandemic in the state.

MCI Order (Oct, 2019) Dog dialysis

As controversy erupted with selection of a convicted physician, Dr. Sukumar Mukherjee, to the “Global Advisory Board” (GAB) to frame medical plans for controlling the COVID-19 pandemic in West Bengal, a second member of the elite GAB, a US-based physician, Thomas Frieden, is also reported to have an equally checkered past. Dr. Frieden was arrested by New York City police for alleged sexual assault on 24th August, 2018 and charged with serious criminal sexual offenses. Dr. Frieden eventually pleaded guilty in 2019 for a lesser charge in order to avoid long jail sentence. This news was widely publicized by major media groups in USA including New York Times and ABC News etc.

Obviously, Dr. Frieden has questionable integrity and moral character to be appointed to the highly powerful medical body (GAB) with final authority to decide how to combat COVID-19 for protection of Bengal residents. Ordinary people of West Bengal would not condone doctors with tainted moral characters to be in charge to protect them from COVID-19. The obvious question is why Mamata Banerjee government nominate doctors with problematic background in formidable positions in GAB. The best explanation for the Mamata Banerjee government would be that perhaps Dr. Frieden was not properly vetted by the government before he was chosen for GAB. Other more sinister explanation would require a thorough and transparent investigation by an independent body. PBT submitted a memorandum to the Bengal CM yesterday informing the tainted history of Dr. Frieden and urging the chief minister to immediately remove Dr. Frieden from GAB to restore public trust for the hapless patients and ordinary citizens of West Bengal (see below).

Statesman (May 5, 2020)

Appeal to Bengal CM (May 3, 2020) Criminal COVID-19 Member

PBT president, Dr. Kunal Saha appeared “in person” through “live” videoconferencing from USA to argue before a 3-judge Supreme Court bench of Justices R.V. Ramana, Sanjay Kishan Kaul and B.R. Gavai in the PIL filed by PBT seeking changes to the widespread recommended “treatment guidelines” for use of unapproved anti-malarial drug, Hydroxychloroquine (HCQ) and broad-spectrum antibiotic, Azithromycin (AZM) in COVID-19 patients. American Heart Association (AMA) and American College of Cardiology (ACC) as well as Canadian Medical Association Journal (CMAJ) have recently issued warnings that use of these drugs may cause serious adverse effects leading to heart failure and death, especially in patients with other cardiovascular conditions like high blood pressure or ischemia. The US Food & Drug Administration (FDA) also issued a drug “safety” warning last week about the “off-label” use of HCQ and AZM in COVID-19 patients. In this PIL, PBT has also sought that even if COVID-19 patients are given the experimental HCQ/AZM, they must be informed about the potential “adverse effects” of these drugs and doctors must obtain “informed consent” before using HCQ/AZM on COVID-19 patients.

After hearing Dr. Saha and the Solicitor General (SG) of India, Mr. Tushar Mehta, Apex Court based an order directing that PBT can email all necessary materials to the SG within 2 days and then SG will bring it to the Indian Council of Medical Research (ICMR) for investigation and necessary action in regard to the concerns raised by PBT. PBT has already filed all the relevant documents to the SG via email and hope that the ICMR will take appropriate precautionary measures, as advised by the international medical organizations, in regard to the use of HCQ/AZM to prevent injuries or death of the COVID-19 patients (see news below).

LiveLaw (Apr. 30, 2020)

The British Medical Journal (BMJ) today published online a “Rapid Response” written by PBT president and USA-based HIV/AIDS scientist, Dr. Kunal Saha, in regard to the rampant use of anti-malarial drug, Hydroxychloroquine (HCQ), in treatment of COVID-19 patients in India (see below, also available at the link: https://www.bmj.com/content/369/bmj.m1432/rapid-responses). The US Food and Drug Administration (FDA) last week issued an extraordinary “Drug Safety Communication” to warn all medical professionals about the potential dangers that may be associated with the use of HCQ including cardiac failure and death. Major International medical groups including American Heart Association (AHA), American College for Cardiology (ACC) and Canadian Medical Association Journal (CMAJ) have also warned against the use of HCQ in COVID-19 patients. PBT has already filed a PIL in the Supreme Court of India seeking directions for mandatory precautionary measures in COVID-19 treatment centers to prevent serious injury or death of patients receiving the unproven therapy with HCQ. PBT has also sought that “informed consent” must be obtained prior to starting HCQ treatment on COVID-19 patients after full disclosure of the potential adverse effects of this drug. This PIL is expected to come up for hearing via videoconferencing before the Apex Court soon.

BMJ (April 26, 2020) Rapid Response – Hydrroxychloroquine in COVID-19

Food & Drug Administration (FDA) in USA issued a stark warning today on the use of anti-malarial drug, Hydroxychloroquine (HCQ), either alone or in combination with Azithromycin (AZM), in the treatment of COVID-19 patients despite president Trump’s vociferous promotion of HCQ (see FDA release below). PBT already lodged a writ petition (PIL) in the Supreme Court against the widespread use of HCQ and AZM in COVID-19 patients without any warning or precautionary measures in place to tackle the serious adverse effects of the drugs. The PIL is expected to be taken up by the Apex Court soon.

Apart from issuing cautions for adverse effects of HCQ in unsuspecting patients, FDA has also categorically held that “Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19”. The “treatment guidelines” published by ICMR and Health Ministry has unequivocally advised that most seriously ill COVID-19 patients in ICU may be treated with a combination of HCQ and AZM based mostly on anecdotal evidence. PBT already sent several appeals to the health ministry urging them to make necessary changes in the treatment guidelines to keep close monitoring of the patients treated with HCQ and AZM as recommended by the American Heart Association and other major international medical bodies. Unfortunately, Health Ministry remained in complete silence forcing PBT to move the PIL. PBT also submitted a memorandum with Health Ministry and ICMR today to take immediate and appropriate measures based on the FDA warnings today to protect the hapless COVID-19 patients treated with HCQ and/or AZM.

FDA Warnings on COVID-Hydroxychloroquine (April 24, 2020)

H. Times (April 25, 2020)

A multi-center study with 368 hospitalized COVID-19 patients in VA hospitals across US was released today underscoring the serious risks involved for “off-label” use of anti-malarial, Hydroxychloroquine (HCQ) and/or broad-spectrum antibiotic, Azithromycin (AZM) in the treatment for COVID-19 patients. The online release of this study found no evidence of any benefit for using HCQ and AZM, either alone or in combination, to prevent serious illness requiring ventilatory support for COVID-19 patients. More alarmingly, the study also finds that use of HCQ alone was associated with an “increased overall mortality” of COVID-19 patients. Based on these frightening data, the researchers have recommended that until the results of other ongoing prospective, randomized, controlled studies are published showing definite benefits for “off-label” use of HCQ and AZM, these drugs should not be recommended for widespread use in COVID-19 patients. The study may be viewed online at the link: https://www.medrxiv.org/content/10.1101/2020.04.16.20065920v1 (copy also attached below). In view of these latest findings, PBT submitted an urgent appeal today to the Health Ministry and ICMR urging them once again to take immediate steps to prevent widespread use of HCQ and/or AZM in the treatment of COVID-19.

A public interest litigation (PIL) was filed last week by PBT seeking directions that Indian healthcare authority must take necessary precautionary measures against potential serious injury and death due to the adverse effects for “off-label” use of HCQ and AZM in COVID-19 patients and that doctors must obtain “informed consent” by candid disclosure of the potential risks associated with these drugs before using these medicines on COVID-19 patients. Our PIL was based on already published scientific studies that warned about possible serious side-effects including death with the “off-label” use of HCQ and AZM in COVID-19 patients. The US study published today provides further support to our pending PIL which is expected to come before the Hon’ble Apex Court soon.

COVID-19:HCQ:Azithromycin Report (April 20, 2020) MedRxiv

Treatment guidelines issued by Ministry of Health and Family Welfare (MOHFQW) have recommended “off-label” use of highly controversial and unproven combination therapy with an anti-malarial drug, Hydroxychloroquine (HCQ) and broad-spectrum antibiotic, Azithromycin (AZM) for seriously ill ICU-bound COVID-19 patients. Serious warnings were issued last week through an urgent joint bulletin by American Heart Association (AHA), American College of Cardiology (ACC) and Heart Rhythm Society (HRS) in USA. Similar warnings for potential irregular heartbeat (arrhythmia), heart failure and possible death were also published last week by Canadian Medical Association Journal (CMAJ). Also, a massive multi-national study with more than 300,ooo patients in USA, UK, Germany, Spain, Netherlands and Japan reported last week of increased “cardiac mortality” in patients receiving MCQ and AZM.

The AHA/ACC/HRS bulletin cautioned doctors using MCQ and AZM on COVID-19 patients to take six specific precautionary therapeutic measures to prevent adverse effects and potential death, especially for patients with pre-existing heart conditions. PBT appealed repeatedly to the Health Ministry to make necessary changes in the treatment guidelines for COVID-19 patients receiving MCQ and AZM and to urgently implement the precautionary measures as advised by the top international cardiac expert bodies (AHA/ACC/HRS/CMAJ) but no action was taken. Compelled to file an urgent PIL in SC today, PBT has sought for immediate implementation of the precautionary measures advised by AHA/ACC/HRS. PBT has also sought that proper “informed consent” must be taken from COVID-19 patients before “off-label” use of MCQ and AZM after explaining all the risks involved as potential adverse effects of these drug combination.

Hindustan Times (Apr. 16, 2020)

Outlook (April 15, 2020) SC PIL COVID

Dr. Sukumar Mukherjee is known all over India as the worst negligent physician against whom highest ever compensation (Rs. 11.5 crore) in Indian medical history was awarded by Supreme Court of India for causing death of Anuradha Saha, wife of PBT president Dr. Kunal Saha. While awarding the highest compensation in 2013, Apex Court also held Dr. Mukherjee as the most reckless physician whose was personal conduct was also so unethical that it was “very much unbecoming of a doctor”. Contrast the scathing Supreme Court’s view to what Bengal CM Mamata Banerjee thinks about the same Dr. Mukherjee today as the state and whole country is ravaged by COVID-19. Mamata Banerjee just dubbed Dr. Mukherjee as “Global Best” in half-page paid advertisements (in tax-payers’ money) in all major dailies in West Bengal today as she lauded the tainted doctor and selected him (and few others) to an elite Board of experts to advise the state government how to control the coronavirus pandemic (see below).

Can the most reckless, negligent, and unethical doctor also be the “global best” to combat COVID-19? Is there no other competent doctor with intact character in West Bengal who is also knowledgeable about coronaviruses? Ironically, Dr. Mukherjee is not a virologist or known to have ever performed viral research as he was a regular internist and retired professor in medicine. Most importantly, by branding a doctor as “Global Best” who was already found guilty for gross medical negligence by the Apex Court, did Bengal CM not clearly violate Article 144 of Indian Constitution that mandates that all authorities, civil and judicial, shall act in aid of the Supreme Court? Ordinary people and countless victims of medical negligence in West Bengal already know the answers to these burning questions.

Ad Telegraph (April 9, 2020)

As US president Donald Trump on a wild run openly promoting widespread use of anti-malarial drugs, Chloroquine and Hydroxychloroquine, to combat COVID-19 without any scientific evidence and against the advice of top researchers at Center for Disease Control (CDC) and National Institute of Health (NIH), Indian government has gone a step further as Indian Council of Medical Research (ICMR) has recommended to use Chloroquine/Hydroxychloroquine as a prophylactic measure by all healthcare workers to prevent COVID-19. Although Chloroquine and Hydroxychloroquine are long known and used for their anti-malarial effects, these drugs are not without potentially serious side-effects on the hepatic, nervous, renal and cardiac systems including prolongation of the QT wave and cardiac arrhythmia. On the face of Trump’s baseless claim for using Chloroquine/Hydroxychloroquine in COVID-19 patients, American Medical Association (AMA) president and other prominent doctors in USA have issued a stark warning that indiscriminate use of these drugs may even be responsible for needless death of patients (see attached).

Going a step further than using Chloroquine or Hydroxychloroquine in the treatment of COVID-19 patients that has little or no scientific evidence, ICMR has recently recommended that all healthcare workers should be treated with these potentially toxic anti-malaria drugs as a measure to protect against the coronavirus. We are not aware about any published scientific study in support of prophylactic use of Chloroquine/Hydroxychloroquine against COVID-19 even though the potential danger of these drugs including possible death is well-known to medical science for a long time. In order to stop promotion of unscientific and irrational use of toxic drugs in any medical condition, PBT has sent a memorandum to the IMCR director requesting to reconsider and change their advice for wide-scale prophylactic use of Chloroquine/Hydroxychloroquine for all health workers in India (see below).

NEWS- AMA president on Chloroquine and COVID-19

To ICMR (Apr. 6, 2020)