Syndicate Supplying Fake Cancer drug Busted #Spurious-Medicine


The rise in “falsified and substandard medicines” has become a “public health emergency”. A surge in counterfeit and poor quality medicines means that thousands of patient  a year are thought to die after receiving shoddy or outright fake drugs intended to treat ailments. Most of the deaths are in countries where a high demand for drugs combines with poor surveillance, quality control and regulations to make it easy for criminal gangs and cartels to infiltrate the market.

There is an  urgent  need for  effort to combat a “pandemic of bad drugs” that is thought to kill hundreds of thousands of people globally every year.

More are thought to die from poor or counterfeit vaccines and antibiotics used to treat or prevent acute infections and diseases. Beyond the fakes that are made and sold by criminal gangs are poor-quality medicines that lack sufficient active ingredients to work properly, or fail to dissolve correctly when taken. Sloppy manufacturing is often to blame, but others are sold past their shelf life or have degraded in poor storage conditions.

    Governments and pharmaceutical companies had to improve the security of the drug supply chain in all countries from the point of manufacture to the patient. Regarding online pharmacies, there is poor public understanding of how to differentiate between a legitimate online pharmacy and an illegal one. Illegal online pharmacies and the sale of medicines via social media platforms pose the greatest risk to the  public.

Deadly Cocktail: to Make  Fake Cancer Drugs- Syndicate Manufacturing & supplying over 21 Spurious Medicines

To make big money, Pradhan got his cousin Shubham Manna and Ram Kumar involved in his plan and started making spurious cancer drugs. “He had been providing spurious medicines at a discounted 50% of market prices. He was manufacturing and supplying more than 21 spurious cancer medicines of various companies of different countries,” special commissioner (crime) Ravindra Yadav said. The syndicate comprised highly-qualified and well-earning individuals. Manna had completed his BTech and served in MNCs before joining hands with Pradhan. Police said his job was to generate barcodes, emboss batch numbers and expiry dates on medicines. He also looked after overall packaging of the spurious medicines. International syndicate used to procure capsules and manufactured fake medicines by filling them with starch.

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CCI investigates India’s largest hospital chains’ Practices


The potential penalty by India’s fair trade regulator could be steep. The CCI  (The Competition Commission of India)  investigation is the first such action against exorbitant prices of medicines and services fixed by hospitals, which have operated free of regulation so far.

A four-year investigation by India’s fair-trade regulator has concluded that some of India’s largest hospital chains abused their dominance through exorbitant pricing of medical services and products in contravention of competition laws.

The Competition Commission of India (CCI) will soon meet to weigh in on the responses by Apollo Hospitals, Max Healthcare, Fortis Healthcare, Sir Ganga Ram Hospital, Batra Hospital & Medical Research and St. Stephen’s Hospital. It will then decide whether to impose penalties, said people familiar with the matter.

The CCI can impose a penalty of up to 10 percent of the average turnover for the past three preceding financial years of an enterprise that has violated competition laws. The penalties could be steep. Apollo Hospitals posted an average turnover of Rs 12,206 crore and Fortis Rs 4,834 crore in the past three financial years.

The CCI’s director-general found that 12 super-speciality hospitals of these chains that operate in the National Capital Region abused their positions of dominance by charging “unfair and excessive prices” for renting rooms, medicines, medical tests, medical devices, and consumables, according to a copy of the summary report that Moneycontrol reviewed.

Some hospital room rents exceeded those charged by 3-star and 4-star hotels, according to the findings by the DG, who examines anti-competitive practices.

Significance of the investigation

The CCI investigation is the first such action against exorbitant prices of medicines and services fixed by hospitals, which have operated unencumbered by regulation so far. The watchdog’s action could potentially rein in the prices of medicines and healthcare equipment, or at the very least, bring transparency in the way hospitals sell these items, according to competition lawyers.

Of the 12 hospitals that faced CCI scrutiny, six belonged to Max  and two to Fortis.

The CCI and the hospital chains had no comment for this article.

Overcharging without checks

Exorbitant pricing is a common thread running through the CCI investigation report. The hospitals were found to charge more for certain medical tests as well as for X-rays, MRI and ultrasound scans than rates offered by other diagnostic centres. For consumables such as syringes and surgical blades, hospitals charged rates that were higher than those of other consumable makers, according to the CCI report.

The only exception was medicines, which hospitals sold at the maximum retail price, although they earned significant profits by procuring them at lower prices.

The CCI selected the hospitals for investigation on the basis of the number of doctors, paramedics, beds, and turnover for the period 2015-2018. The investigation found that these hospitals do not allow the use of purchase of consumables, medical devices, medicines and medical test results from outside, adding that patients use the service of in-house pharmacy and laboratories for ease of convenience.

Investigative reports pertaining to each of the hospital chains were submitted by the DG to the CCI on December 24, 2021. The CCI forwarded a copy of these reports to the hospitals on July 12, 2022, and sought their responses, according to the people, who did not want to be identified.

The CCI has been examining the pharmaceutical sector in India for years, scrutinising the pricing of medicines by healthcare companies. On April 19, 2020, it cautioned businesses, including healthcare companies, against taking advantage of Covid-19 to contravene competition laws.

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Antibiotic for resistant super bugs discovered by machine learning (AI) for first time


 

An important breakthrough   towards  discovering new antibiotics, that has potential to change  the ways, new molecules are discovered,  Team at MIT says HALICIN  kills some of the world’s most dangerous strains. Discovery  has been possible using artificial intelligence.  It also signifies the role of artificial intelligence in medicine, in future.

Antibiotic resistance arises when bacteria mutate and evolve to sidestep the mechanisms that antimicrobial drugs use to kill them. Without new antibiotics to tackle resistance, 10 million lives around the world could be at risk each year from infections by 2050.

To find new antibiotics, the researchers first trained a “deep learning” algorithm to identify the sorts of molecules that kill bacteria. To do this, they fed the program information on the atomic and molecular features of nearly 2,500 drugs and natural compounds, and how well or not the substance blocked the growth of the bug E coli.

A powerful antibiotic that kills some of the most dangerous drug-resistant bacteria in the world has been discovered using artificial intelligence.

The drug works in a different way to existing antibacterials and is the first of its kind to be found by setting AI loose on vast digital libraries of pharmaceutical compounds.

Tests showed that the drug wiped out a range of antibiotic-resistant strains of bacteria, including Acinetobacter baumannii and Enterobacteriaceae, two of the three high-priority pathogens that the World Health Organization ranks as “critical” for new antibiotics to target.

“In terms of antibiotic discovery, this is absolutely a first,” said Regina Barzilay, a senior researcher on the project and specialist in machine learning at Massachusetts Institute of Technology (MIT).

“I think this is one of the more powerful antibiotics that has been discovered to date,” added James Collins, a bioengineer on the team at MIT. “It has remarkable activity against a broad range of antibiotic-resistant pathogens.”

Once the algorithm had learned what molecular features made for good antibiotics, the scientists set it working on a library of more than 6,000 compounds under investigation for treating various human diseases. Rather than looking for any potential antimicrobials, the algorithm focused on compounds that looked effective but unlike existing antibiotics. This boosted

the chances that the drugs would work in radical new ways that bugs had yet to develop resistance to.

Jonathan Stokes, the first author of the study, said it took a matter of hours for the algorithm to assess the compounds and come up with some promising antibiotics. One, which the researchers named “halicin” after Hal, the astronaut-bothering AI in the film 2001: A Space Odyssey, looked particularly potent.

Writing in the journal Cell, the researchers describe how they treated numerous drug-resistant infections with halicin, a compound that was originally developed to treat diabetes, but which fell by the wayside before it reached the clinic.

Tests on bacteria collected from patients showed that halicin killed Mycobacterium tuberculosis, the bug that causes TB, and strains of

Enterobacteriaceae that are resistant to carbapenems, a group of antibiotics that are considered the last resort for such infections. Halicin also cleared C difficile and multidrug-resistant Acinetobacter baumannii infections in mice.

To hunt for more new drugs, the team next turned to a massive digital database of about 1.5bn compounds. They set the algorithm working on 107m of these. Three days later, the program returned a shortlist of 23 potential antibiotics, of which two appear to be particularly potent. The scientists now intend to search more of the database.

Stokes said it would have been impossible to screen all 107m compounds by the conventional route of obtaining or making the substances and then testing them in the lab. “Being able to perform these experiments in the computer dramatically reduces the time and cost to look at these compounds,” he said.

Barzilay now wants to use the algorithm to find antibiotics that are more sekills only the bugs causing an infection, and not all the healthy bacteria that live in the gut. More ambitiously, the scientists aim to use the algorithm to design potent new antibiotics from scratch.

“The work really is remarkable,” said Jacob Durrant, who works on computer-aided drug design at the University of Pittsburgh. “Their approach highlights the power of computer-aided drug discovery. It would be impossible to physically test over 100m compounds for antibiotic activity.”

“Given typical drug-development costs, in terms of both time and money, any method that can speed early-stage drug discovery has the potential to make a big impact,” he added.

Antibiotic resistance

 

 

Medical device harms, hidden by regulator: policies akin to protection @USFDA


        

                   Modern medicine has been captivated by the  industry. In the name of people’s health, business and industry  receives a kind of  protection  by none other than regulator itself.  The report about USFDA,  hiding the adverse events or device failure and harm is just one example how  powerful  industry has become.  It is not always possible to identify  complications arising out of device failure and there can be possibility of  these  not  being reported. The numbers that are hidden may also represent a fraction of  actual number of harms related to device.  A sad truth of present era, where doctors are punished  and blamed for human errors or even  natural poor prognosis,  Medical industry remains not only  hidden behind the scenes, but  receives  policies akin to protection  by regulator.

USFDA ‘hid’ reports of medical device snags The US Food and Drug Administration (FDA), which claims to have stringent processes in place to ensure safety of medical devices, has been found to maintain a “hidden database” of reports of serious injuries and malfunction of devices. Since 2016, over a million incidents that were reported went to the hidden database rather than to the publicly available database of suspected device-associated deaths, serious injuries and malfunctions. This was revealed in an investigation carried out by Kaiser Health News, a US-based non-profit news service covering health news. The revelation has serious implications for India, which approves a lot of devices based on USFDA approval. KHN found that “about 100” devices including mechanical breathing machines and balloon pumps were granted “reporting exemptions” over the years. The investigation revealed that many doctors and engineers dedicated to improving device safety not only did not know the issues raised in these reports, they didn’t even know about the existence of the “hidden database” or the exemptions. While the agency hid such crucial information about device risks, lawsuits and FDA records show that patients have been injured, hundreds of times in some cases, noted KHN. According to KHN, FDA confirmed that the “registry exemption” was created without any public notice or regulations. “Any device manufacturer can request an exemption from its reporting requirements,” an FDA spokesperson told KHN. The USFDA’s public database that tracks medical device failures, Manufacturer and User Facility Device Experience (MAUDE), receives thousands of medical device reports that are used to detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. These reports are submitted by mandatory reporters — manufacturers, importers and device user facilities — and by voluntary reporters — healthcare professionals, patients and consumers. MAUDE is used by doctors to identify problems or to check the safety record of a particular device. But they could reach the wrong conclusion as they would be unaware of and have no access to the reports on the “registry exempted” products, pointed out a former FDA official to KHN. For instance, KHN found that in 2016, while reports of only 84 stapler injuries or malfunctions were submitted to the public database, nearly 10,000 malfunction reports were included in the hidden database. Medtronic, which owns Covidien, considered to be the market leader in surgical staplers, had used reporting exemption. Surgical staplers are used to cut and seal tissues or vessels quickly, especially during minimally invasive surgeries and if the device fails the patient could bleed to death unless the doctors moved quickly to resuscitate the patient and seal the tissue/vessel. After the KHN report was published, the FDA has written to doctors expressing concern about the safety of surgical staples and staplers. The agency said it has received reports of 366 deaths, over 9,000 serious injuries and over 32,000 malfunctions. The letter also acknowledged that the FDA was aware that “many more device malfunction reports during this time frame” were submitted as “summary reports”. The agency said it was analyzing the reports and that the results would be made public. According to the KHN report, the FDA has deemed manufacturers of over 5,600 types of devices including cardiac stents, leadless pacemakers and mechanical heart valves, eligible to file “voluntary malfunction summary reports”, one of the many exemption programmes. Ironically, in India, doctors and regulators have argued that FDA has the most stringent regulation for devices compared to regulators in Europe, Canada, Australia or Japan and have even sought to make it mandatory for devices to have USFDA approval to be eligible for government procurement tenders. This was especially evident during the efforts to cap the price of stents when top cardiologists argued for higher prices or even price cap exemption for USFDA-approved stents.

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