Judge Shielded Merck Enabling Concealment of Drug Safety Hazards
by Vera Sharav
Alliance for Human Research Protection (AHRP)
A Reuters investigative report reveals how Federal judges are complicit in shielding pharmaceutical giants like Merck & Co. by allowing the company to conceal the evidence of real risks of harm from widely prescribed drugs. The risks are concealed from physicians and the public.
“It goes without saying that the more information a physician has, the more he can share with the patient and the more informed the decision-making process becomes.” — Nelson Novick, MD
Merck’s Corporate Rap Sheet includes court adjudicated lawsuit findings against the company which has paid multi-billion dollars in settlements for False Claims, Product Safety/Concealment of serious adverse effects, Bribery, Tax fraud, and more.
Multiple Merck products caused severe harm, including deaths; these include: the arthritis drug Indocin® (1960s); the widely prescribed drug for pregnant women, diethylstilbestrol (DES)® drug that caused women vaginal cancer (1970s); Vioxx®, the painkiller prescribed for arthritis (1999-2004) caused, 140,000 heart attacks and an estimated30 to 60,000 deaths.
Merck paid $4.85 Billion to settle Vioxx lawsuits. Another controversial drug is Fosamax® prescribed for osteoporosis (1990s) which causes osteonecrosis of the jaw and thighbone fractures; Januvia® , linked to pancreatitis, pancreatic cancer, and severe joint pain.
A Reuters investigative reporter Dan Evine, reveals how Judge Brian Cogan – who sat in judgment over 900 Propecia® lawsuits in New York federal court – enabled Merck to conceal the documents that proved the company’s culpability.
Propecia which has been marketed in the U.S. since 1999, causes sexual dysfunction, even after it is no longer used.
Confidential documents reviewed by Reuters accuse Merck of exaggerating the drug’s safety record.
Citing internal company communications, these legal briefs filed by plaintiffs’ lawyers allege that in revisions to the drug’s original 1997 label, Merck understated the number of men who experienced sexual symptoms in clinical trials, and how long those symptoms lasted.
Other documents show that Merck knew roughly 20 years ago that sales of the drug would suffer if the public became aware of Propecia’s possible long- term effects on men’s sexual health.
A redacted section of one plaintiffs’ motion, reviewed by Reuters, cites correspondence from a Merck executive in which he objected to what he described as “misleading” information about the incidence of sexual dysfunction in men taking Propecia.
That information was placed on the drug’s label despite his comments, the court document says, and it remains there today.
Merck is THE major U.S. vaccine manufacturer
Merck vaccines include: Gardasil, the HPV vaccine; MMR (measles, mumps, rubella), Pneumovax (Pneumococcal), Recombivax HB (Hepatitis B), Rota Teq (Rotavirus), Varivax (Chickenpox – varicella), Zostavax ( Shingles – herpes zoster)
In contrast to Merck’s liability for harm caused by its marketed drugs, Merck is shielded from liability for harm caused by its childhood vaccines by the National Childhood Vaccine Injury Act of 1986.
The NCVIA shields vaccine manufacturers from open court litigation
This legal blockade and unfair disparity shields the Merck and the other vaccine manufacturers by denying injured children and their families the right to fair judicial review – including the right to obtain company documents under the rules of Discovery. Merck’s data and documentation about vaccine safety hazards are, therefore, concealed. Neither physicians nor the public is informed about the true nature of those risks.
Not content with this government-guaranteed legal shield, Merck and the vaccine lobby – which is comprised of pharmaceutical companies, government and their financially tied institutions and influential opinion leaders in the medical establishment, in academia, and in the media – are waging an aggressive lobbying campaign to enact laws mandating vaccination.
California, New York, and Maine have gone so far as to eliminate all exemptions from vaccines that are recommended by the Centers for Disease Control, whose officials are closely aligned with Merck. [read more here and here]
The push for mandatory vaccination is not limited to the U.S. – it is a coordinated global agenda facilitated by corrupt government officials.
Court let Merck hide secrets about a popular drug’s risks
Lawsuits claim baldness drug Propecia causes sexual problems and depression. The judge sealed evidence – uncovered by Reuters – suggesting the maker downplayed the side effects. A widow wants the truth out.
Excerpts:
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.
Merck has denied the allegations in court filings and declined to comment further on Pfaff’s case. In a statement to Reuters, Merck said it “stands behind the safety and efficacy of Propecia,” noting that the drug has been prescribed safely to millions of men since the late 1990s. While the drug’s label lists erectile dysfunction and other sexual problems as possible side effects among a small percentage of men, the company rejects allegations that Propecia causes those problems to persist after men stop taking it or that it can lead to mental health issues. Merck says the symptoms themselves could be caused by a variety of other factors.
However, confidential documents reviewed by Reuters accuse Merck of exaggerating the drug’s safety record. Citing internal company communications, these legal briefs filed by plaintiffs’ lawyers allege that in revisions to the drug’s original 1997 label, Merck understated the number of men who experienced sexual symptoms in clinical trials, and how long those symptoms lasted. Other documents show that Merck knew roughly 20 years ago that sales of the drug would suffer if the public became aware of Propecia’s possible long- term effects on men’s sexual health.
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