Can J&J's Brand Family Stage Recall Recovery?

"I think this is unprecedented," said Don Riker, OTC drug consultant and publisher of the OTCProductNews blog. "I'm not sure there's ever been a case where you've had so much destocking of a brand for such a long period of time..."

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Are Marketers Hiking Ad Spend at Expense of Product Quality?

"Donald Kay Riker, a consultant with On Point Advisors and publisher of the OTC ProductNews, 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…"

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"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…"

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Total Recall: Tylenol Troubles Lose J&J $1.4B as Brands Are “Eradicated"

"I think this is unprecedented,” said Don Riker, OTC drug consultant and publisher of the OTCProductNews blog. “I’m not sure there’s ever been a case where you’ve had so much destocking of a brand for such a long period of time."

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"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..."

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"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…”

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"It will be a banner year for Tylenol

Bayer Aspirin is Feeling Plenty Healthy

"Consumers are running scared," says Donald Riker, a consultant on over-the-counter drugs and editor of OTC Product News. "There's been a shift in the trust in the products and the brands."

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“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…”

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"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'."

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Delaware health: Allergy drug Allegra now available over counter

"Though Chris Arabis usually can be found on a golf course on sunny spring days, the freshly cut grass and tree pollen sometimes make it hard for him to enjoy the game."

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New cause found in most recent Tylenol recall

"Manufacturing failures emerge from the line; quality failures emerge from the boardroom"

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P&G/Teva manufacturing savvy threatens J&J

"Procter & Gamble's plan to ride Teva's manufacturing expertise shows just how valuable a manufacturing operation can be. That's not to say that the ops boost for P&G is the essence of the joint-venture deal struck late last week by the two. Teva will enjoy the ride in P&G's marketing and brand management limo.

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J&J Plant Report Renews Calls for Consent Decree

"Donald Riker, president and founder at On Point Advisors, says the decree in this case is necessary to enforce manufacturing and quality assurance regulations...Riker of On Point says the most recent 483 comments "continue to reflect a widespread systemic failure of a rogue manufacturing operation trying to fix itself."

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Consent Decree Trumps Prosecution in Some Cases

"Riker, using his OTC Product News platform, has called for the FDA to seek a judicial consent decree governing J&J's manufacturing of OTC products. 'Despite warning letters, FDA monitoring and plant shut-downs it's time for the public health to come first,' he writes."

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Weldon Preps for Congress; Denies "Systemic" J&J Quality Problem

"Evidence speaks for itself," says Donald Riker, president at healthcare industry consultancy On Point Advisors. J&J has "embarked on a review of its entire operation and appointed a senior manager over all QA, presumably changing reporting relationships, hiring new people, putting in new SOPs." Riker in July called the Tylenol recalls a "rolling blackout," possibly the result of a "systemic failure."

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"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."

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"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."

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"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."

 

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"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."

 

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Why J&J's Headache Won't Go Away

"'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.'"

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"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' ."

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“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.

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“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”

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Can Johnson & Johnson Get Its Act Together?

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“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...”

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J&J Sells Rolaids To Sanofi, But What Goes Next?

“Divesting some of these brands may make great sense as a way of recouping some value, avoiding further losses and reducing risk,” Donald Kay Riker, who runs OnPoint Advisors, a consumer healthcare products consulting firm, and editor of OTC Product News, writes us.

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Achoo! Sanofi And A Questionable Allergy Test

"In the hands of an allergy specialist, skin patch testing in the doctor’s office is the accepted practice for determining sensitivity to aero-allergens. Blood tests, such as RAST testing, are secondary"

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“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….”

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“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.”

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

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“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...”

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Sanofi unit acquires Rolaids from J&J

Don Riker…said: ‘This is probably a smart move on everybody’s part. It’s the kind of niche Chattem has a long history of acquiring and growing. For J&J it allows them to refocus on Tylenol and not be distracted by smaller niche brands"

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Chattem To Revive Rolaids Line Bought From J&J

"Don Riker, president of On Point Advisors...expects the claims war between [Tums & Rolaids] to be centered on their acid neutralization stories, speed of relief and the presence or absence of magnesium hydroxide, which has a laxative effect, some would say to counteract the constipating effect of calcium carbonate."

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Medagate Turns OTC Purchases Into Data For Manufacturers, Insurers

" 'The process shifts costs from insurers to consumers... additionally, insurers likely will learn something about consumers' health care habits from the sales data.  Many first-line treatments have moved OTC - they need a handle on that', Riker said"

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Matrixx Rejected On ProPhase Labs Bid

" 'I think it's a smart move on Matrixx's part --- they gain control of the niche, more shelf space, merchandizing space, they gain clinical trials and data that might be useful to support both cold lines,' said Don Riker, president of consumer health products consultancy On Point Advisors... 'Whatever their motives, if you add all that up, they might see it as an inexpensive way to capture that [pipeline] without the risk', Riker said."

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"OTC brand consultant Donald Riker said the combination of being linked to the NyQuil brand and having a single-ingredient formulation could position ZzzQuil well in the marketplace...the whole point of Nyquil was to relieve symptoms so you could rest, but now P&G is trying to shoehorn NyQuil into a narrower sleep-aid positioning, Riker said...the real competition is Advil PM and Tylenol PM..."

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J&J Recalled To Capitol Hill As Besieged Consumer Group Chair Retires

"Goggin's looming departure is a necessary step in the firm's "cleansing process", and Weldon could be next to move on, said Don Riker, President of consumer health products consultancy On Point Advisors"

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“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…”

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“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…”

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“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…”

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“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…”

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Patches for Pain Relief Take Hold in U.S.

"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..."

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