Gilead prices Covid-19 drug candidate remdesivir at S$3,258 per patient in US

WASHINGTON — Gilead Sciences has priced its Covid-19 drug candidate remdesivir at US$390 (S$543) per vial for the United States and governments of other developed countries, it said on Monday (June 29), setting the price of a five-day course at $2,340 (S$3,258) per patient.

The price for US private insurance companies will be US$520 per vial, the drugmaker said, which equates to a total of US$3,120 per patient.

Experts have suggested that Gilead would need to avoid the appearance of taking advantage of a health crisis for profits.

Wall Street analysts have said the antiviral drug could generate billions of dollars in revenue over the next couple of years if the pandemic continues. REUTERS

Read more at https://www.todayonline.com/world/gilead-prices-covid-19-drug-candidate-remdesivir-s3258-patient-us

 

 

Johnson & Johnson told to pay S$2.9 billion over cancer-causing talc powder

WASHINGTON — A US court has upheld a verdict that talcum powder sold by Johnson & Johnson caused ovarian cancer and ordered the pharmaceutical giant to pay US$2.1 billion (S$2.9 billion) in damages.

Read more at https://www.todayonline.com/world/johnson-johnson-told-pay-s29-billion-over-cancer-causing-talc-powder

 

Controversial Hospital Sale in Malaysia Draws Questions

Insurance fraud rife

Soon after Pakatan Harapan’s victory in the general election in 2018 a local insurance insider, wrote the editor of Kuala Lumpur-based tabloid The Star, alleging that medical insurance fraud is rife in Malaysian private hospitals. Although a complaint was filed to Prudential Assurance in November 2019 confirming the submission of the false claims, Prudential managers, including Dr Siva, Director of the Claims Department and Dr Ashish, Head of Medical Business Management responsible for managing the PCMC account initially brushed off the complaints.

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There is an urgent need to clean up the medical industry of fraudulent insurance claims. This is not a victimless crime, it is Malaysians who are at risk from doctors and hospitals that put fees ahead of patient welfare and it is Malaysians who are paying excessive health insurance premiums because of the greed of a few. So far, the only response from medical industry, professional bodies and the Ministry of Health is to erect a wall of silence.

Complaints to multiple agencies including the Ministry of Health, Private Medical Practice Control Branch (CKAP) and Dzulkifli Ahmad, the Minister of Health have fallen on deaf ears. Neither the hospital nor the Malaysian Medical Commission has replied to Asia Sentinel’s requests for interviews.

Source: https://www.asiasentinel.com/p/controversial-hospital-sale-in-malaysia

Murray Hunter’s exposé on alleged medical malpractice in Malaysia is a bitter pill to swallow – “Patients betrayed: Malaysian Medical Council Protects its Own”

Regulatory agency goes with the malpractice flow

Concerns are growing in Malaysia that trust in its healthcare system is struggling under the weight of declining standards, rising incidents of malpractice and failure to hold errant doctors to account, an existential threat to the country’s ambition to market itself as a Southeast Asian medical tourism destination.

The integrity of the MMC is in crisis. The scandal threatens people’s lives, which once harmed or even taken away, can never be recovered. Urgent reform is required, beginning with the removal of errant members of the MMC governing council and PICs who are appointed by the Minister of Health, Dr Dzulkifli Bin Ahmed who has been fully informed of this malpractice in the MMC.

Source: https://www.mariammokhtar.com/murray-hunters-expose-on-alleged-medical-malpractice-in-malaysia-is-a-bitter-pill-to-swallow-patients-betrayed-malaysian-medical-council-protects-its-own/

https://www.asiasentinel.com/p/patients-betrayed-malaysian-medical-e17

 

 

 

Court let Merck hide secrets about a popular drug’s risks

PARK CITY, Utah — By the time Kelly Pfaff got home from driving her son to school that morning, it was too late.

Her husband, John, was supposed to be taking their 4-year-old daughter to school. But the girl and the nanny were still at the Pfaffs’ house near San Diego. So were John’s wallet, cellphone and wedding ring. John was gone.

Kelly was alarmed, but not surprised. For four years, she had watched her husband, once a successful information-technology executive, avid skier and doting father, spiral inexplicably into despair.

It had started with dark, sulking moods. Then he lost interest in sex. His wife asked him if he was having an affair. “No … Something’s just not right down there,” Kelly said her husband told her. Panic attacks set in.

He suspected the cause might have been Propecia, the popular Merck & Co drug he had been taking to treat hair loss since around the time his problems started. He quit the pills, but still he couldn’t sleep, and he flashed random anger at the children. He started talking about killing himself.

On the morning of March 5, 2013, about 45 minutes before his wife got home, John Pfaff stepped onto the railroad tracks a block away and into the path of a southbound Amtrak train. He was killed on impact.

Kelly Pfaff blames Merck for her husband’s death at age 40. In a lawsuit filed in 2015, she alleges that the pharmaceuticals company for years knew but concealed from the public that Propecia could cause the persistent sexual dysfunction and depression that led to her husband’s suicide about a year after he quit taking the drug.

John Pfaff wasn’t the only man who experienced sexual problems after taking Propecia. His widow’s lawsuit was one of more than 1,100 filed across the United States and consolidated in so-called multidistrict litigation (MDL) in federal court in Brooklyn, New York. They accuse Merck of not adequately warning patients of the drug’s possible side effects and their duration.

Read more: https://www.reuters.com/investigates/special-report/usa-courts-secrecy-propecia/

Oxycontin maker Purdue offers US$10-12 bil for opioid claims

NEW YORK: Purdue Pharma, whose prescription painkiller Oxycontin is blamed for much of the US opioid addiction epidemic, has offered US$10-12 billion to settle thousands of claims against the company, NBC News reported Tuesday.

The news of the negotiations came a day after another major drugmaker, Johnson & Johnson, was found guilty in the first trial of producers and distributors of prescription opioids now blamed for more than 400,000 overdose deaths in less than two decades.

J&J was ordered by an Oklahoma court to pay the state US$572 million in damages for its role in stoking the crisis.

Purdue earlier this year was dropped from the suit after agreeing to pay Oklahoma US$270 million in damages.

The Ohio case brings together nearly 2,300 separate opioid cases brought by states, cities, towns and Native American tribes, claiming tens and possibly hundreds of billions of dollars in damages.

They argue that the companies in the chain of opioid production and distribution hid the dangers of their drugs and did nothing to control massive sales and over prescription until it became evident that millions of Americans were hooked on them, causing more than 47,000 opioid overdose deaths in 2017 alone.

Read more: https://www.freemalaysiatoday.com/category/world/2019/08/28/oxycontin-maker-purdue-offers-us10-12-bil-for-opioid-claims/

 

One soft drink a day could increase your risk of cancer

It’s no secret – too many soft drinks are far from good for our health, but did you know that drinking even just one soft drink a day could increase your risk of cancer – regardless of the size of your waistline?

A new study by Cancer Council Victoria and the University of Melbourne analysed more than 35,000 Victorians over a twelve year period who developed 3,283 cases of obesity-related cancers including liver, ovary, pancreas and gallbladder.

“We were surprised to find increased cancer risk was not driven completely by obesity,” said Associate Professor Allison Hodge of Cancer Council’s cancer epidemiology and intelligence division.

“Even though these cancers were commonly associated with obesity, our research found this risk existed for all participants, no matter their size.”

“Even people who were not overweight had an increased risk if they regularly drank soft drinks. This was not the case with those who drank diet soft drinks, suggesting sugar is the key contributor.”

 

Source: https://www.cancervic.org.au/about/stories/soft-drink-increase-cancer-risk.html

Consumption of sugary drinks linked with cancer risk: Study

https://www.channelnewsasia.com/news/world/consumption-of-sugary-drinks-linked-with-cancer-risk-study-11710186

One cup of soft drink a day linked to 18 per cent increased cancer risk: study

Source: https://www.smh.com.au/lifestyle/health-and-wellness/one-cup-of-soft-drink-a-day-linked-to-18-per-cent-increased-cancer-risk-study-20190711-p5266d.html

How sugary drinks can fuel and accelerate cancer growth

Source: https://www.medicalnewstoday.com/articles/324773.php

J&J faces U.S. criminal probe related to baby powder

(Reuters) – The U.S. Justice Department is pursuing a criminal probe into whether Johnson & Johnson lied about potential cancer risks of its talcum powder and has convened a grand jury in Washington, Bloomberg reported on Friday, citing people with knowledge of the matter.

The Bloomberg report said the grand jury was looking into documents related to what company officials knew about any carcinogens in their products. (here)

J&J disclosed in its annual report in February that it had received subpoenas from the Justice Department and Securities and Exchange Commission related to the ongoing baby powder litigation but did not give more details.

Source: https://www.reuters.com/article/us-johnson-johnson-talc-probe/jj-faces-u-s-criminal-probe-related-to-baby-powder-bloomberg-idUSKCN1U726J

Pharmacy warns FDA of cancer-causing chemical found in widely used heart pill

Source: https://www.cnbc.com/2019/06/18/fda-warned-of-cancer-causing-chemical-found-in-heart-pill.html

  • A pharmacy warns the FDA that it found a chemical believed to cause cancer in a widely used blood pressure medication, according to a filing.
  • Valisure told FDA that high levels of dimethylformamide were found in valsartan, a drug produced by Novartis and other pharmaceutical companies.

A pharmacy warned the Food and Drug Administration that it found a chemical believed to cause cancer in a widely used blood pressure medication, according to a filing from the federal agency.

Valisure, an online pharmacy company licensed in 37 states, told the FDA last week that high levels of dimethylformamide were found in valsartan, a drug produced by Swiss drugmaker Novartis and other pharmaceutical companies. The drug is used to treat hypertension in adults. The World Health Organization classifies dimethylformamide, or DMF, as a probable human carcinogen.

 

The Biopharmaceutical Industry Provides 75% Of The FDA’s Drug Review Budget. Is This A Problem?

Source: https://www.forbes.com/sites/johnlamattina/2018/06/28/the-biopharmaceutical-industry-provides-75-of-the-fdas-drug-review-budget-is-this-a-problem/#23560bc849ec

Caroline Chen of ProPublica has written a provocative article challenging the objectivity of the FDA in its approval of new drugs. Entitled: “FDA Repays Industry by Rushing Risky Drugs to Market”, Chen contends that the agency is beholden to the biopharmaceutical industry which pays three quarters of the FDA’s budget used for the drug review process. This is an astounding number. Is any other federal agency supported to this extent by the industry it regulates? Given this level of support, one might assume that the FDA would bend over backwards to meet the needs of its financial backers.

FDA Repays Industry by Rushing Risky Drugs to Market

As pharma companies underwrite three-fourths of the FDA’s budget for scientific reviews, the agency is increasingly fast-tracking expensive drugs with significant side effects and unproven health benefits.

Source: https://www.propublica.org/article/fda-repays-industry-by-rushing-risky-drugs-to-market#

Nuplazid, a drug for hallucinations and delusions associated with Parkinson’s disease, failed two clinical trials. In a third trial, under a revised standard for measuring its effect, it showed minimal benefit. Overall, more patients died or had serious side effects on Nuplazid than after receiving no treatment.

Patients on Uloric, a gout drug, suffered more heart attacks, strokes and heart failure in two out of three trials than did their counterparts on standard or no medication.

The FDA is increasingly green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease.

As patients (or their insurers) shell out tens or hundreds of thousands of dollars for unproven drugs, manufacturers reap a windfall.

“Instead of a regulator and a regulated industry, we now have a partnership,” said Dr. Michael Carome, director of the health research group for the nonprofit advocacy organization Public Citizen, and a former U.S. Department of Health and Human Services official. “That relationship has tilted the agency away from a public health perspective to an industry friendly perspective.”

FDA often approves drugs despite limited information. It channels more and more experimental treatments, including Nuplazid, into expedited reviews that require only one clinical trial to show a benefit to patients, instead of the traditional two.

Faster reviews mean that the FDA often approves drugs despite limited information. It channels more and more experimental treatments, including Nuplazid, into expedited reviews that require only one clinical trial to show a benefit to patients, instead of the traditional two.

The FDA also increasingly allows drugmakers to claim success in trials based on proxy measurements — such as shrunken tumors — instead of clinical outcomes like survival rates or cures, which take more time to evaluate. In return for accelerated approval, drug companies commit to researching how well their drugs work after going on the market. But these post-marketing studies can take 10 years or longer to complete, leaving patients and doctors with lingering questions about safety and benefit.

Industry also sways the FDA through a less direct financial route. Many of the physicians, caregivers, and other witnesses before FDA advisory panels that evaluate drugs receive consulting fees, expense payments, or other remuneration from pharma companies.