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.

Opioid drugmaker Insys Therapeutics files for bankruptcy

(Reuters) – Drugmaker Insys Therapeutics Inc filed for Chapter 11 bankruptcy protection on Monday, about a week after agreeing to pay $225 million to settle a U.S. probe into bribes it paid to doctors for prescribing a powerful opioid medication.

A month earlier, a federal jury in Boston found Insys founder John Kapoor and four other former executives and managers guilty of engaging in a vast racketeering conspiracy.

Subsys is an under-the-tongue spray the U.S. Food and Drug Administration approved in 2012 only for treating pain in cancer patients. Its main ingredient, fentanyl, is an opioid 100 times stronger than morphine.

Prosecutors alleged that while Kapoor served as Insys’ chairman, the company from 2012 to 2015 paid doctors and other medical practitioners bribes in exchange for prescribing Subsys to their patients, often to those who did not have cancer.

Insys did so by paying medical practitioners to act as speakers at sham events ostensibly meant to educate clinicians about Subsys.

Prosecutors said the scheme helped boost sales of Subsys, whose net revenue grew from $8.6 million in 2012 to $329 million in 2015. Insys went public in 2013 with what became the best-performing initial public offering of that year.

Source: https://www.reuters.com/article/us-insys-opioids-bankruptcy/opioid-drugmaker-insys-therapeutics-files-for-bankruptcy-idUSKCN1TB15Q