Baylor College Probes Avandia And Ghostwriting

Make a commentBy Ed Silverman // July 16th, 2010 // 10:18 am

Ban on gifts from industry must stay – The Boston Globe

RE “BAN on drug industry gifts could be lifted’’ (Metro, June 25): As a community physician, I feel obliged to speak out against the proposed repeal of our state’s pharmaceutical industry gift ban.

My colleagues and I are all very aware of how pervasive and corrupting this industry’s aggressive marketing tactics have been. The existing law, instituted less than two years ago, is just part of what needs to be a larger ongoing attempt to reduce and eliminate the massive overspending and unsound medical decisions that result from unrestrained pharmaceutical marketing.

Senate Joins Probe Into The J&J Recall Scandal

Make a commentBy Ed Silverman // May 25th, 2010 // 12:03 pm

New Study Suggests the Cipro Antibiotic May Be Behind Drug-Resistant Bacteria

This is the sort of supervision that sales reps just can’t stand. As part of the $81 million settlement that two Johnson & Johnson units paid to resolve criminal and civil lawsuits over illegally promoting the Topamax epilepsy drug, J&J’s Ortho-McNeil compliance personnel must ‘ride along’ with reps and “directdly observ(e) all meetings” between reps and health care providers.

“The observations shall be scheduled throughout the year, randomly selected by compliance personnel and other appropriately trained (compliance) representatives as described above, include each therapeutic area and actively promoted product, and be conducted across the United States,” according to the Corporate Integrity Agreement that was part of the settlement.

And once the ride is over, the compliance police must file a report identifying the rep; the date and duration of the observation; the product(s) promoted; an overall assessment of compliance with policy, and the identification of any potential off-label promotional activity by the rep. Presumably, reps will be on their best behavior? But who monitors the monitors? You know, what if they go out for a beer after a hard day riding together to visit countless hard-to-pigeonhole docs? 

The CIA attempts to address this by stipulating that sales reps must endure a mandatory three-hours of training on regulatory law and the penalties for violations, as well as the hiring of an independent review organization to help assess and evaluate promotional activities. Good luck to all.

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Johnson & Johnson may have used bacteria-tainted materials in making more than 40 types of children’s pain and allergy medicines recalled last week, U.S. regulators said.

The company’s McNeil Consumer Healthcare unit failed to protect those drugs from contamination or correct manufacturing deficiencies at its Fort Washington, Pennsylvania, production plant, Food and Drug Administration officials said yesterday in a conference call with reporters. None of the products tested positive for bacteria, though FDA inspectors found microorganisms in some raw materials used as inactive ingredients in the drugs, said Deborah Autor, director of compliance at the FDA’s Center for Drug Evaluation and Research.

“This is yet another example of the need for companies to take full accountability for the quality of their drugs and of the serious consequences that can happen when companies do not do so,” Autor said.

J&J recalled some types of infant and children’s Tylenol, Motrin, Zyrtec and Benadryl because of “manufacturing deficiencies” that could affect quality, purity or potency of the drugs, the FDA said May 1. The recall involved over-the- counter drops and liquids in sizes ranging from 0.5 ounces (14 milliliters) to 4 ounces, J&J’s McNeil unit said in a separate statement on April 30.

Switch Medicines

While the potential for the recalled drugs to cause illness is remote, parents who bought any of J&J’s brand-name children’s products named in the recall should stop using them and switch to generic versions of the medicines, Autor said.

“You’ve got a company that’s considered one of the premier companies, that’s spent something like 100 years building its reputation,” Les Funtleyder, an analyst with Miller Tabak & Co., said yesterday in an interview. “This is the kind of thing that can hurt that.”

J&J, the world’s largest health products company, said it suspended production at the Pennsylvania plant on April 30 when it announced the recall. The company said again in a statement yesterday that it won’t resume operations until corrective actions have been taken in consultation with the FDA.

“This step comes on top of others we already have taken to ensure quality compliance,” the company’s McNeil unit said in the statement. “Early this year, we initiated a comprehensive assessment of quality and manufacturing systems across our operations. We have committed extensive internal resources to this effort, and brought in independent outside experts to assist us.”

J&J failed to take action after receiving 46 consumer complaints in the past 10 months about “foreign materials, black or dark specks” in the products, the FDA said in a 17- page inspection report posted yesterday on its website.

Debris, Dust Found

Agency officials found violations including a “large exposed hole” in a laboratory ceiling and “a large amount of visible grey and brown dust” and debris inside a laboratory incubator, according to the report of last month’s inspection at the Fort Washington plant. While the findings are serious, it’s too early to say whether further FDA action is warranted, Autor said during the conference call.

The recall isn’t likely to hurt New Brunswick, New Jersey- based J&J financially, said Linda Bannister, an analyst with Edward Jones & Co.     “We’re not concerned about the damage from an actual profitability standpoint,” she said in a telephone interview. “Although J&J is built on a pretty solid reputation, if this expands or becomes more of an issue and J&J’s reputation suffers, that’s when it could begin to become problematic.”

In January, J&J recalled over-the-counter medicines including Rolaids, Motrin, some Tylenol brands, Benadryl, St. Joseph’s Aspirin and Simply Sleep caplets after receiving complaints about musty odors in Tylenol caplets and reports of nausea, vomiting and diarrhea after use.

J&J may lose any good favor it had with the FDA as a result of the most recent action, Funtleyder said. The New York-based analyst said he still recommends buying J&J shares, “because it’s a good company.”

To contact the reporters on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net; Meg Tirrell in New York at mtirrell@bloomberg.net