Donald Kay Riker, a consultant with On Point Advisors and publisher of the OTCProductNews.com blog, believes cost cutting and integration of the Pfizer brands may have helped lead to problems for J&J. He also believes the low status of quality-control executives may be playing a role in rising drug recalls generally…

click to read

"Sanofi agreed to pay $1.9 billion in cash -- a rich four times more than 2008 sales -- pending regulatory and shareholder approval for Chattem, a company assembled over the years from a hodgepodge of brands cast off by bigger players…"

click to read

“Sanofi's immediate need of marketing and distribution know-how in the US OTC business found a willing partner in Chattem…”

click to read

"Please read Donald Kay Riker’s story on the troubles at Johnson & Johnson. It is, plain, weird that J&J is in such a state with its great brands such as Tylenol. Riker, who is a longtime OTC pharma exec and and now of On Point Advisors and OTC Product News..."

click to read

"Many of America’s best known consumer healthcare brands were caught up in a “voluntary” recall of contaminated products. Johnson & Johnson announced the recall late Friday, January 15th…”

click to read

"It will be a banner year for Tylenol—for all the wrong reasons. The company has recalled 50 of its children’s over-the-counter medicines and shut down its Fort Washington, Pa., factory as...

click to read

“We conclude that the nasal challenge model is a reproducible method to evaluate the efficacy of anti-allergic medications. For nasal corticosteroid trials, sneezing, symptom scores and albumin levels are recommended as the most reproducibly suppressive outcome measures…”

click to read

"The lawsuit quotes Dr. Riker, a health care consultant and editor of OTC Product News, who allegedly stated that diphenhydramine is an antihistamine discovered just after World War II and 'was never designed to be [a] sleep aid or analgesic'."

click to read

"The pain patch business is in a kind of regulatory limbo, says Riker. The FDA has issued no final ruling on its regulation, despite a petition by the Consumer Healthcare Products Association...if the FDA ultimately requires NDAs, "Hisamitsu has a big head start," Riker says. The foreign manufacturer has "played by the rules" while domestic manufacturers appear to have "placed their bets on the usual slowness of the FDA and are still playing the clock."

click to read

"If Good Manufacturing Practices are about anything, it's control: Control of equipment, processes, and the activities of those who put the two together to make drugs."

click to read

"This rolling blackout could be the result of FDA diving into a badly broken systemic failure," writes Donald Riker, president at On Point Advisors, in OTC News. "However, a more cynical view would be that J&J has micromanaged the recall to optimize its inventory pipeline."

 

click to read

"Healthcare industry consultant Donald Riker, president at On Point Advisors, believes the pallets were sprayed with bleach, dispersing the contaminant into the air and onto the walls and ceiling of plant. In an interview with FiercePharmaManufacturing, he says in an interview it's well known that bleach can convert the TBP in the preservative used on the pallets to the contaminant TBA."

 

click to read

"'At every step in this process J&J has not been transparent,' says Don Riker, a consultant to OTC drug companies. 'Every bit of information is cagey, secretive, and micromanaged.'"

"'McNeil, has undergone a wrenching cultural change, and a quality-assurance department that crumbled as its mistakes were overlooked -- at times, some former employees say, deliberately.'"

click to read

"Donald Riker, founder of On Point Advisors, describes the Tylenol recalls of the past few months as 'the systemic failure and partial collapse of overarching quality systems within J&J, in theory involving all plants and brands until otherwise proven.  There is no way now to judge the full extent of the system failure which is internal to the company, self-inflicted, and always within its sphere of control' ."

click to read

“TENS is not recommended for the treatment of chronic low back pain.” Their conclusion, now widely disseminated throughout the media, does a disservice to those receiving benefit from TENS. In the accompanying editorial, Drs. Binder and Baron correctly state that the efficacy of TENS remains unclear until proven: “Absence of evidence is not evidence of absence.”  - Donald K. Riker, Ph.D.

click to read

“Assessment: efficacy of transcutaneous electric nerve stimulation in the treatment of pain in neurologic disorders (an evidence-based review); utility of transcutaneous electrical nerve stimulation in neurologic pain disorders”

click to read

“FDA finds OTC sleep-aid data lacking: Reuters reports FDA's determination that data on the combination of acetaminophen and diphenhydramine are insufficient to support a monograph indication for relief from sleeplessness due to aches and pains. The agency's recent letter, responding to a data submission from industry 15 years ago, could put the kibosh on claims made for Johnson & Johnson's Tylenol PM and Novartis' Excedrin PM. Our colleague Donald Riker at OTC Product News also blogs on the topic, looking at the science behind the ingredients...”

click to read

“In a sharply worded editorial at OTC ProductNews.com, a trade journal, editor Donald Riker, who has a doctorate in neurobiology, said the FDA inspection [of J&J’s plant] revealed "a breathtaking track record of failure."  Riker said the likelihood that children received more Tylenol than intended raises health concerns, despite FDA assurances that the chance of ill effects from the company's problems seems remote. Overdoses of Tylenol (or, generically, acetaminophen) can cause liver failure. "The fact that these are products targeting infants makes it even more reprehensible," he said….”

click to read

“Donald Riker, the editor-in-chief of OTC Product News, an independent consumer health publication, sent me a link to their analysis which makes some excellent points - just possibly smarter than mine - about the manufacturer's (Johnson & Johnson) long-term failure to accept responsibility or modify the packaging and warning labels until ordered to this month by the FDA.‘Before long J&J's new logo will be the skull & crossbones in the eyes of consumers,’ Riker writes. It's a great line, isn't it? Wish I'd thought of it myself.”

click to read.

“By buying PBM Holdings, Perrigo is betting that generic infant formula can claim a significant piece of the high-margin market…”

click to read

“French pharma Sanofi-Aventis SA cited several reasons for its $1.9 billion purchase of Chattem Inc., the Chattanooga, Tenn., maker of Gold Bond, Icy Hot and other over-the-counter health brands, announced in December. By far the most important...”

click to read

“Sanofi-Aventis will need to build an infrastructure geared to Rx-to-OTC switch in order to make a successful U.S. consumer business out of its planned acquisition of Chattem and become established as a switch player…”

click to read

“Sanofi-Aventis' $1.9 billion bid for OTC and personal care product firm Chattem offers the French firm a coveted toehold in the sizeable U.S. consumer health care market while also opening potential opportunities in emerging markets…”

click to read

“FDA's announcement it is investigating a possible risk of liver injury related to orlistat - the active ingredient in Roche Pharmaceuticals' prescription weight-loss drug Xenical and GlaxoSmithKline's OTC Alli - could threaten short-term sales…”

click to read

“Lawsuits alleging that zinc in two popular denture creams damages nerves, combined with the recent recall of some zinc-containing Zicam products, could call into question the use of the mineral, which trade groups insist is safe when taken appropriately…”

click to read

An active ingredient in most of these pain-relief patches is menthol, which creates a warming sensation that jams the nervous system's receptors for pain, says Don Riker, president of On Point Advisors LLC, a healthcare consultant. "It's like wasabi to the skin," Mr. Riker says...

click to read