Medical 'Ethics': Only 8 of 68 New Cancer Drugs Getting Euro Approval Are Worth Squat

The more things change the more they stay the same.

The story's at Fierce Pharma, so you'll have to read it at the link.

Here's the BMJ report.

Jury Orders J&J To Pay $72 Million In Ovarian Cancer Talcum Powder Case

The Credo Co. takes another PR hit.

drugwatch
Posted February 24th, 2016 by Michelle Llamas & filed under Current Litigation & Lawsuit News.

A Missouri jury awarded the family of a woman a multi-million dollar verdict against Johnson & Johnson after she sued the Big Pharma giant claiming the company’s talcum powder caused her ovarian cancer.

The St. Louis jury found J&J knew about the link between talc-based products and cancer for decades and failed to warn the public. They found the company liable for fraud, negligence and conspiracy. The jury ordered J&J to pay $10 million in compensatory damages and $62 million in punitive damages. This is the first verdict to award damages in a talcum powder case.

For decades, women used talcum powder for feminine hygiene, sprinkling it on undergarments and the vaginal area to prevent odor or extra moisture. A 2013 study published in Cancer Prevention Research showed women who used talcum powder in the groin area had up to 30 percent greater risk in developing ovarian cancer.

Plaintiff Jackie Fox died of ovarian cancer after using Johnson’s baby powder and Shower to Shower for feminine hygiene for more than 35 years. She died last year at age 62.

Fox’s attorney, Jere Beasley, said J&J “knew as far back as the 1980s of the risk,” but still lied to the public and regulatory agencies, Reuters reported.

J&J has not stated whether it will appeal the verdict, but it stands by its product.

“We have no higher responsibility than the health and safety of consumers, and we are disappointed with the outcome of the trial,” Carol Goodrich, a Johnson & Johnson spokeswoman, said in a statement. “We sympathize with the plaintiff’s family but firmly believe the safety of cosmetic talc is supported by decades of scientific evidence.”

The company still faces about 1,200 more lawsuits from women and their families saying J&J was aware of the risk, but did nothing to warn consumers.

Juror: It Was Clear J&J was ‘Hiding Something’

According to jury foreman Krista Smith, internal company documents presented at trial allowed the jurors to reach a verdict after only four hours.

“It was really clear they were hiding something. All they had to do was put a warning label on,” Smith told Bloomberg.

In this case, Fox’s lawyers revealed a 1997 letter from a former J&J consultant “warning that the company’s responses to the findings of nine scientific studies could end up comparing the talc industry to the cigarette industry,” the National Law Journal reported.

Talc Controversy

Scientists suspected for decades that talcum powder could be linked to ovarian cancer. In the 1970s, researchers theorized that particles of talc could enter a woman’s body through the vagina and make their way to the ovaries. Since then, more studies found links between talcum powder and cancer. Though, the findings are still steeped in controversy.

Still, baby powder is a multi-million dollar product, and the revenue generated is estimated at about $19 million. About 19 percent of baby powder users in the U.S. use J&J’s brand. The company still sells talc-based products even after the American Cancer Society encouraged women to switch to cornstarch for use in the genital area in 1999.

Fox’s award is the largest verdict to date in this type of case, but this is not the first time J&J found itself in court over its talc products.

Deane Berg used Johnson’s Baby Powder and Shower to Shower powder as a feminine hygiene product from 1975 to 2007. Like Fox, she filed a lawsuit after she was diagnosed with ovarian cancer and three doctors found talc particles embedded in cancerous tissues. The jury found J&J failed to warn, but did not award compensatory damages.

Thank You Ms Llamas and Drug Watch.

Psychiatric Labels: More Likely To DIE From Heart Disease And Cancer

The Mental Elf has;
People With Schizophrenia Are Significantly More Likely To Die From Heart Disease And Cancer
Posted by André Tomlin at 9:00 am
Since starting this blog two years ago, I have written about a number of studies that highlight the health inequalities faced by people with severe mental illness.

The evidence keeps piling up and it’s really quite shocking that we are not doing more to diagnose and treat physical health problems in people with conditions such as schizophrenia and bipolar disorder:

• People with mental illness are prescribed fewer drugs for physical disorders than the rest of the population (Jun 2012)
• People with mental illness are still dying young and this is a violation of human rights, says new editorial (Dec 2011)
• Mental health problems and colon cancer: a double-whammy that leads to poor cancer outcomes (Dec 2011)
• Middle-aged smokers with schizophrenia are significantly more likely to die from cardiac disease (Oct 211)
• People with mental illness are 11% more likely to die after cardiac events than the rest of the population (Jun 2011)

People with severe mental illness generally have more contact with the healthcare system and yet they are still living 15-20 years less than the rest of the population.

A new cohort study has recently been published in the American Journal of Psychiatry, which can be added to this list. It looks at the association between schizophrenia, comorbidities and death, in both inpatients and outpatients.

Methods

The authors (from Stanford University in California and Lund University in Malmö, Sweden) used data following over 6 million Swedish adults (aged 25 and older) from 2003-9.

8,277 people were diagnosed with schizophrenia during the 2 years prior to the start of the study.

Scandinavian cohort studies often provide us with much more comprehensive data than we would get elsewhere, because the outpatient and hospital registries in countries like Sweden provide virtually complete data sets.

The study population was followed for 7 years and comorbidities and mortality were assessed to ascertain whether people with schizophrenia had different risk profiles to those without schizophrenia.

Results

• People with schizophrenia died earlier than everyone else (on average men died 15 years earlier and women 12 years earlier) and this was not accounted for by unnatural deaths
• Schizophrenia patients had no increased risk of nonfatal ischaemic heart disease or cancer diagnoses, but they were more likely to die from:
  • Ischaemic heart disease
    • Adjusted hazard ratio for women, 3.33 (95% CI=2.73–4.05)
    • Men, 2.20 (95% CI=1.83–2.65)
  • Cancer
    • Women, 1.71 (95% CI=1.38–2.10)
    • Men, 1.44 (95% CI=1.15–1.80)
• Looking at everyone who died from heart disease or cancer, schizophrenia patients were less likely than others to have been diagnosed previously with these conditions:
  • For ischaemic heart disease, 26.3% compared with 43.7%
  • For cancer, 73.9% compared with 82.3%
• The association between schizophrenia and mortality was stronger in women and the employed
• Elevated mortality was also associated with a lack of antipsychotic treatment

Conclusions

The authors concluded:

Schizophrenia patients had markedly premature mortality, and the leading causes were ischaemic heart disease and cancer, which appeared to be under-diagnosed. Preventive interventions should prioritise primary health care tailored to this population, including more effective risk modification and screening for cardiovascular disease and cancer.

The findings of this study can be added to the growing evidence base that people with severe mental illness are not getting the care and support they need for other health conditions.

As the recent National Schizophrenia Audit reminds us, more needs to be done to monitor and manage the physical health of people with schizophrenia.

Links

Crump C, Winkleby MA, Sundquist K, Sundquist J. Comorbidities and Mortality in Persons With Schizophrenia: A Swedish National Cohort Study. Am J Psychiatry. 2013 Jan 15. doi: 10.1176/appi.ajp.2012.12050599. [PubMed abstract]

Thank You Mental Elf and Mr Tomlin

HT to Mad In America