Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Friday, March 6, 2015

Johnson and Johnson Legacy: public drugging and shoddy products.



Happy Birthday RW Johnson! A Legacy

Friday, 20 February 2015 10:38 
By Kathleen Sharp, Truthout | News Analysis
Today (February 20) is the 170th birthday of one of history's most influential drug salesmen, Robert Wood Johnson, co-founder of the health-care giant Johnson & Johnson.
This event comes on the heels of decades of fraud and injury claims against J&J, along with billion-dollar payouts. It's not as if J&J is alone: Virtually every pharmaceutical firm has been probed, sued and fined for fraud and wrongful death cases. Indeed, there is growing evidence that many modern drugs obtained regulatory approval based on faulty "scientific" and "optimistic" studies conducted by their manufacturers.
A quick review of the life of RWJ makes one realize that the dodgy origins of the pharmaceutical business are, a century and a half later, still with us.
To be fair, RWJ didn't actually start J&J. His younger brothers, James and Edward, formed the firm after seeing a huge demand for pain relief and energy concoctions. The brothers had worked as medicinal "travelers" in the antebellum days, selling bottles and tinctures from the back of a wagon or a train. It was the 1880s, an era of patented "medicines," whose secret ingredients often included morphine, opium and 40-proof alcohol. The Johnsons knew there was money to be made in such hokum, but they weren't cut out for sales. Mild-mannered and middle-aged, they had failed at other businesses and had little to show for their long hours on the road. Then, they spied an abandoned factory on the banks of New Jersey's Raritan River. Borrowing $1,000, they moved into the top floor of a former wallpaper factory, and, in February of 1886, started manufacturing medicinal plasters.
But they were no match for their snake-oil competitors. Johnson & Co., as it was then called, floundered for months until big brother Robert stepped in. He'd been working as a wholesale druggist and was a brash businessman, with Wall Street ties and investments. That autumn, he took control of the company, infused it with $100,000 (equivalent to about $2 million today) and started to "borrow" liberally from the ideas of Joseph Lister, a famous British surgeon who believed that airborne germs were "invisible assassins" and who advocated sterilizing surgical instruments.
RWJ never signed a licensing agreement with the doctor, but he slapped Lister's name on many of his products, from fumigators and plasters to even dog soap. Wily Robert also slashed prices lower than that of his scrappiest rival. As he told one salesman: "We have concluded to stick the knife right into the bowels of the plaster business." And he did.
At the turn of the 20th century, the average American apparently needed extra vigor and pain relief, symptoms of toiling six or seven days a week for robber barons. Many a shrewd "traveler" promised a quick fix: The Wyeth brothers sold Sun Opium Tablets; Mr. Bayer unrolled the Heroin Cough Suppressant and Parke & Davis pushed their patented Cocaine Injection Kit.
To keep pace, RWJ imported Tasmanian poppies and 100,000 pounds of belladonna a year, so much belladonna, that he decided to grow the exotic plant himself. He advertised his "extra high grade" of plant, which he sold only to J&J "friends" at the "highest prices in the world," $2 a pound, with a limit of three jars a friend. From the first day of business, horses and wagons lined up at Johnson's Bellevue Farm to cart away as much of the dangerous nightshade as their drivers could stomach, according to a company-approved biography. Sales of belladonna liver poultices and "female remedies" boomed.
But RJW's genius was hiring a clever apothecary and ad man, Fred Kilmer. Kilmer wrote effusive, sometimes fictitious, claims about J&J products. He called himself a doctor, stole the distinctive Red Cross brand from its founder Clara Barton and published a newsletter called the Red Cross Messenger. In it, "Dr. Kilmer" advertised new J&J products such as Vino Kolafra, an invigorating mix of cola nuts and cheap sherry. Upon experimenting with it, Dr. Kilmer recommended the stimulant for bicyclists on long runs and for doctors making late-night collections.
But an alarming number of people fell sick from these concoctions. Young mothers grew ill from the belladonna "remedies;" husbands hid their flasks of heroin-laced medicine; children grew addicted to spiked sarsaparilla and babies died after ingesting opium cough syrups.
In 1905, finally, Collier's Weekly magazine published a muckraking piece that exposed the industry's chicanery in all its sordid details. "Legislation is the most obvious remedy," Samuel Hopkins Adams wrote, and the series so outraged the public, Congress passed the first federal drug law. The Pure Food and Drug Act of 1906 banned the manufacture and sale of poisonous patent medicines, but alas, the law had no teeth. Narcotic cures and dangerous substances continued to fly out of J&J warehouses.
Even so, the press had put America's "public druggers" such as J&J on notice. More deaths triggered a 1912 law that required all drug makers to list the contents of their products on the labels­­­­, a requirement that remains to this day. In 1938, Congress passed the Food, Drug, and Cosmetic Act ,which finally put some bite into consumer protection laws. Uncle Sam could now seize any drug it suspected of being dangerous, and, soon, over-the-counter opium tablets and cocaine vino went the way of hoop skirts and buggy whips. For the first time in US history, the burden of proof of a medicine's safety shifted to its manufacturers, and evidence-based scientific studies became the rule.
For 50 years, these laws helped usher in a string of life-saving treatments, which were supported by real science; medicines such as penicillin; an antibiotic for tuberculosis; and vaccines against polio, measles and mumps. Rather than hurt the drugmakers, regulations actually helped them. J&J, Merck and Parke-Davis (now called Pfizer) produced so many innovative products that profits boomed and people respected these brands. J&J, for one, became one of the most admired companies in the world.
By the late 1980s, however, drug companies became too dominant, and US regulators lost clout. J&J and its rivals began engaging in fraud and shoddy practices, according to dozens of lawsuits and federal plea deals. The US Food and Drug Administration (FDA) launched multiple investigations of J&J, tied to its illegal marketing and advertising ploys, and the relatives of deceased loved ones have sued the firm for its dangerous, lethal products.
For example, Natrecor was approved for acute heart failure, but J&J marketed it for chronic heart conditions, despite its severe side effects.  J&J's Ortho Evra birth control patch contained dangerously high levels of estrogen and was 12 times more likely to cause strokes than birth control pills. The poorly tested patch killed healthy young women, according to dozens of suits.
During the aughts, tens of thousands of kids were given J&J's antipsychotic Risperdal, sometimes illegally, which caused teenage boys to grow breasts, girls to gain weight, and many to contract diabetes. Even so, J&J continued pushing the drug illegally by telling their sales force to "butter up doctors" with free golf trips and bags of "Risperdal Popcorn," according to one former employee



An Articular Surface Replacement or A.S.R., all-metal artificial hip device made by the DePuy orthopedics unit of Johnson & Johnson, that was removed from a patient, March 31, 2010. A jury in Los Angeles on March 8, 2013 ordered Johnson & Johnson to pay more than $8.3 million in damages to a Montana man in the first of more than 10,000 lawsuits pending against the medical products maker in connection with the now-recalled artificial hip all-metal device. (Joshua Borough/The New York Times)

Faulty hip replacement systems,  risky blood boosters, Rolaids heartburn products with metal particles inside,  tainted Children's Tylenol . . .   Even Baby Shampoo at one point was found to have had carcinogenic chemicals.  It's as if a century after RJW's glory days, a whiff of hucksterism still trails J&J like sawdust at a traveling medicine show.
Earlier this year, Science News published a story about how too many pharmaceutical company drug studies cannot be replicated when tested by independent scientists. Randomized controlled clinical trials have long been the gold standard for evaluating medicine, but when you can't replicate these studies in independent settings, you might as well sell sugar pills. "There's a community sense that this is a growing problem," Lawrence Tabak, deputy director of the National Institutes of Health told the magazine.

It's as if RWJ is still running the world's biggest health-care company.

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