Johnson &Johnson Still Sees Impact of Recalls, But Brands Are Coming Back!

Johnson & Johnson avoided a third consecutive year of sales declines in 2011 — sales rose 5.6%, to $65 billion, last year, according to the company’s latest financial report, out this week.

The WSJ reported that the company is still feeling the impact of quality-related recalls over the past two years. All of the recalls at J&J’s McNeil business cost it about $900 million in sales in 2010.

The company didn’t do a similar break-out for 2011. However, as you can see from the financial results, sales at its U.S. over-the-counter/nutritionals unit (which is mostly McNeil) fell 23% to $1.43 billion last year from $1.85 billion in 2010.

That implies a drop of about another $400 million last year, though other factors besides the recalls are likely reflected in the decline. (Sales fell 37%, or by $1.04 billion, to $1.85 billion in 2010, a larger amount than the $900 million the company attributed to the recalls.)

CEO William Weldon told analysts that Johnson & Johnson is making progress on the quality-control and other fronts. “We have turned the corner on a particularly difficult period for our company,” he said. And by the end of this year, he expects McNeil to reintroduce most of the OTC brands that were affected by recalls and haven’t yet returned to store shelves.

Some products are already back: the company began shipping Tylenol Cold & Flu Severe caplets in September, while the first Tylenol kids’ products started returning to shelves in November 2010.

J&J also said it was making progress addressing the requirements of an FDA consent decree it signed last March covering a now-closed plant in Fort Washington, Penn. as well as two other plants that are still open. The Fort Washington plant is expected to reopen next year.

Remediating the problems with the McNeil business will cost money; J&J said it sees slightly higher costs associated with those fixes this year compared to 2011.

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Study Suggests Daily Aspirin Is Not for Everyone

Approximately a third of middle-aged Americans regularly take a baby aspirin in the hope of preventing a heart attack, a stroke or lowering risks of cancer. But new research now shows that aspirin is not for everyone, and that in some patients this so-called “wonder drug” is doing more harm than good.

“I stop a lot more aspirin than I start,” said Dr. Alison Bailey, director of the cardiac rehabilitation program at the Gill Heart Institute at the University of Kentucky. “People don’t even consider aspirin a medicine, or consider that you can have side effects from it. That’s the most challenging part of aspirin therapy.”

Recently researchers in London reported in the Archives of Internal Medicine that they had analyzed nine randomized studies of aspirin use in the United States, Europe and Japan that included more than 100,000 participants. The subjects in the study had never had a heart attack or stroke and all of them regularly took aspirin or a placebo to determine whether aspirin benefits people who have no established heart disease.

In the combined analysis, the researchers found that regular aspirin users were 10 percent less likely than the others to have any type of heart event and 20 percent less likely to have a nonfatal heart attack. Now at first you might think this sounds like good news, but the study showed that the risks of regular aspirin outweighed the benefits.

Aspirin users were about 30 percent more likely to have a serious gastrointestinal bleeding event, a side effect of frequent aspirin use. The overall risk of dying during the study was the same among the aspirin users and the others. And though some previous studies suggested that regular aspirin use could prevent cancer, the new analysis showed no such benefit.

Overall, for every 162 people who took aspirin, the drug prevented one nonfatal heart attack, but caused about two serious bleeding episodes.

“We have been able to show quite convincingly that in people without a previous heart attack or stroke, regular use of aspirin may be more harmful than it is beneficial,” said Dr. Sreenivasa Seshasai of the Cardiovascular Sciences Research Center at St. George’s, University of London.

Even with all of this information, the findings are likely to add to the confusion about who should regularly take aspirin and who should not.

Research shows that among men who have had a heart attack, regular aspirin use can be lifesaving, lowering the risk of a second heart event by 20 to 30 percent. It also reduces the risk of a recurrence among women who have had a stroke caused by a blood clot.

Aspirin works by interfering with the blood’s clotting action. In blood vessels narrowed by heart disease, fatty deposits can burst, leading to the quick formation of a clot that blocks the flow of blood to the heart or brain. Regularly taking an aspirin helps prevent the clot from forming. In 2007, the United States Agency for Healthcare Research and Quality reported that 19 percent of Americans regularly took aspirin, including 27 percent of those ages 45 to 64 and about half of those 65 and older.

Yet many current aspirin users have never had a heart attack or stroke, and take aspirin in the hope of preventing one. Among middle-aged aspirin users, the 2007 report found, 23 percent didn’t have established heart disease. Among older aspirin users, 41 percent didn’t have a history of heart disease or stroke.

For people without heart disease, guidelines from the United States Preventive Services Task Force and other national groups say aspirin therapy should be decided case by case, depending on the individual’s risk factors and family history.

But Dr. Seshasai said the new findings didn’t necessarily mean that healthy men and women should immediately stop taking aspirin. People with a strong family history of heart attack or stroke may benefit by continuing the regimen, and they should raise the question with their doctors.

“The decision to treat such individuals with aspirin should be made on a case-by-case basis, taking into account the likely risk of heart attack or stroke in the future,” he said. “However, as the risk of major bleeding episodes increases proportionately with an increase in benefit, physicians and patients must make carefully considered choices regarding long-term aspirin treatment.”

Some experts say the problem is that not every doctor has caught up with the latest science, and many patients decide on their own to take aspirin.

“They hear aspirin is good, so they take an aspirin,” Dr. Bailey said. “They don’t think of it as something that could potentially cause harm.”

As always…if you have any questions about this topic, please reach out to your local pharmacist or healthcare provider.

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Walgreens and Express Scripts Battle

Walgreen’s, the nation’s largest pharmacy chain, does have a history of battling with any adversary, but the typically their disputes with pharmacy benefit managers and even Walgreen’s unionized employees have ended in agreement. However, the drugstore’s latest battle with Express Scripts Inc. may prove to be Walgreen’s first loss. And it’s turning dirty.

This is how it went. Walgreen’s and Express Scripts have failed to reach an agreement on the renewal of their current contract, which expired 1/1/12. This means members of Express Scripts, including certain unions, government agencies and corporations, will be unable to fill prescriptions at any of Walgreen’s drugstores (approximately 8,000 locations). Apparently the terms Express Scripts offered Walgreen’s were below the industry average cost to provide the prescription. Walgreen’s CEO, Gregory Wasson, in a recent conference call with analysts said that they believed that this partnership was no longer in the best interest of their company, customers, employees and shareholders. Regardless of who said what…both parties have repeatedly indicated that they would not budge on what they each considered an unfair deal.

“The two companies appear to have strong fundamental differences of opinion about their respective market power and the priorities of payers regarding cost control and pharmacy access,” said Mark Miller, financial analyst at William Blair & Co., in a research note.

As a pharmacy benefit manager, Express Scripts operates its own mail-order prescription service and negotiates with pharmacies and drug companies to process prescriptions for its members. The company said in a release that it “is receiving strong support from clients and expects greater than 95 percent of its clients’ prescription volume will move forward into 2012 without Walgreens as a network provider.”

Wasson says it is still too early to tell how much of Express Scripts members’ business the chain will be able to retain. Though he and other executives have consistently refused to provide a real estimate of what customer retention might actually be, Wasson said, “We do feel that we are having a positive response from all of our partners.”

In total, Express Scripts members accounted for 90 million of the 819 million prescriptions Walgreen’s pharmacy filled last year, according to Michael Polzin, Walgreen’s vice president of corporate communications. In November, the company said it expects to hold on to 97 to 99 percent of last year’s prescription volume. That’s a pretty large expectation to have.

Thom Gross, Express Scripts’ senior manager of communications, said he doubts the loss of access to Walgreen will inconvenience many customers.

“Of our tens of millions of members, fewer than two in 10 filled a prescription at Walgreens last year, and about one in 10 used only Walgreens for their prescriptions. We currently have more than 60,000 retail pharmacies in our network. We will (still) have more than 56,000 if Walgreens chooses to leave the network Jan. 1.”

The split will certainly bring some losses for both companies. But analysts are forecasting that Walgreen will be the bigger loser of the pair.

Now speaking of Walgreen’s (@Walgreens)…the brand is running a Promoted Trend on Twitter today, called #ILoveWalgreens. At first glance most might think this is an obvious trend to capture customers favorite things about Walgreens. But after diving into it…it’s more of a jab towards Express Scripts (@ExressScripts), and how recently their contract together ended. I do believe that Walgreens intended for the trend to capture love from their customers, but it went sour. Both brands started to attack each other through Tweets. Some are coming from followers, but they are still displayed on the brand pages. They also have put a lot of effort into stealing customers from each other. Below are some examples.

Walgreens Promoted Trend today states, “Patients should be able to choose their pharmacy, not @ExpressScripts. Tweet using #ILoveWalgreens to show your support!”

@Walgreens – “It's time to take a stand against @ExpressScripts. Tell them people want a choice by tweeting hashtag #ILoveWalgreens”

@ExpressScripts - “On our negotiations with Walgreens… Fact 1: Walgreens unilaterally stated in June it would leave our network in January.”

@ExpressScripts – “On our negotiations with Walgreens… Fact 2: Walgreens’ proposed rates/terms would make them the most expensive pharmacy in our network.”

@ExpressScripts – “On our negotiations with Walgreens… Fact 3: What Express Scripts does: make the use of Rx drugs safe, affordable and accessible.”

@ExpressScripts – “On our negotiations with Walgreens… Fact 4: With over 56,000 pharmacies in our network (http://bit.ly/tehtko), there is plenty of access.”

@ExpressScripts – “On our negotiations with Walgreens… Fact 5: It’s easy to switch. Just take your empty pill bottle to your new pharmacy; they’ll do the rest..”

@ExpressScripts – “On our negotiations with Walgreens… Fact 6: The vast majority of our clients and members have already moved on, and more plan to do so.”

Regardless which side you stand on in this battle…please remember to think before you post something over social media. Because once you do…it can never be erased.

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Novartis Drug Recall

Novartis is recalling some bottles of Excedrin, NoDoz, Bufferin and Gas-X Sunday over concerns that the bottles could contain stray pills from other medicines, or chipped or broken tablets.

The news follows Novartis' recent decision to temporarily suspend production at its Lincoln, Neb., plant for "maintenance and other improvement activities."
The Swiss drug maker said it implemented the recall, which affects U.S. retailers, voluntarily and is working with the Food and Drug Administration during the process. It became aware of the potential problem during an internal review that identified broken and chipped pills, and inconsistent bottle packaging that could cause pills to be mixed up. The company said it wanted to make sure that customers didn't take any pills that they might be allergic to or that might become dangerous when mixed with their other medications, though it also said that there have been no such reports from consumers.

Novartis said that some of the bottles of headache medicine Excedrin and caffeine caplets NoDoz with expiration dates of Dec. 20, 2014, or earlier will be subject to the recall. Some of the packages of pain medicine Bufferin and stomach medicine Gas-X with expiration dates of Dec. 20, 2013 or earlier will also be affected.

The company said it will post more information this week at www.novartisOTC.com. Customers can also call the company at 1-888-477-2403 Monday to Friday, 9 a.m. to 8 p.m. EST. You can also contact your local pharmacist or healthcare provider if you have any questions.

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Recall Watch - Johnson & Johnson pull about 12 million bottles of Motrin

There currently is a recall of a frequently used pain killer, Motrin. According to Johnson & Johnson the recall has become necessary because, “testing of product samples showed that some caplets may not dissolve as quickly as intended when nearing their expiration date”. In a statement from the company’s Consumer Healthcare Division, Johnson & Johnson says that consumers do need to dispose of or return the product since there are no safety concerns. But consumers taking Motrin may notice a delay in relief. Johnson & Johnson said it recalled about 12 million bottles of Motrin brand painkillers.

As Dow Jones Newswires reports, it’s not a consumer-level recall. With that being said…people aren’t being asked to get rid of or return unused Motrin bottles. Rest assured there are no safety concerns with the pills, some of which were distributed in the U.S.

WSJ kept tabs on Johnson &Johnson’s string of recalls (across all products), which cost them about $900 million in sales in 2010. Below is the running list:

• In September, J&J pulled about 200,000 syringes of its Eprex anemia drug at the wholesale and pharmacy level because some batches of the drug might not have been sufficiently potent.
• In August, J&J said it was recalling from wholesalers and stores almost 2.5 million packages of Tylenol Cold Multi-Symptom Nighttime Rapid Release Gelcaps due to higher-than-expected levels of a certain compound.
• In late June, McNeil Consumer Healthcare division said it was pulling one lot, or 60,912 bottles, of Extra-Strength Tylenol in the U.S. following “a small number of odor reports.” The smell has been linked to trace amounts of a chemical that’s a byproduct of a preservative sometimes applied to wooden pallets used in storage and transportation. It’s not toxic but can cause GI upset.
• In mid-June J&J pulled 16,000 bottles of Risperdal due to the same odor issues.
• J&J said in May it would pull an estimated 2,000 bottles of Prezista in four European countries due to odor.
• In April J&J recalled about 57,000 bottles of Topamax because of the smell.
• In late March, McNeil Consumer Healthcare pulled about 34,000 bottles of Tylenol 8-Hour Extended Release caplets because of a musty odor. Separately, it widened a wholesale-level recall of Tylenol, Benadryl and Sudafed products.
• Also in March, J&J’s Ethicon unit recalled about 360,000 units of surgical-wound draining products on concerns that the package’s sterility could be compromised.
• Earlier that month, J&J’s Animas unit recalled more than 384,000 insulin-pump cartridges in the U.S. and France, saying they have the potential to leak and give a too-low dose.
• J&J’s Ethicon unit issued a late-December alert in the U.K. that it was recalling about 585,000 surgical sutures. The sutures were mostly sold in Europe.
• In late February, J&J recalled more than 667,000 Sudafed packages at the wholesale level after a typo on the packaging (“do not not divide, crush, chew, or dissolve the tablet”) was discovered.
• Earlier in February, J&J said it was pulling at least 395 injection pens preloaded with rheumatoid-arthritis drug Simponi because they may not deliver a full dose of the drug.
• Days before, we reported that the company’s Ethicon unit recently recalled 700,000 vials of a liquid wound sealant and also a hernia-treatment product.
• Earlier that same week, J&J said it was recalling 70,000 syringes preloaded with its Invega injectable anti-psychotic drug because cracks have been found in the syringes that could theoretically lead to infections or under-dosing in users.
• In January J&J said it would pull 43 million bottles of certain Tylenol, Benadryl, Sinutab and Sudafed products because they were made at the company’s Ft. Washington, Pa., plant at a time when equipment may not have been properly cleaned. J&J also said it would pull almost 4 million units of Rolaids due to a labeling problem.
• In December 2010 the company said it was recalling all lots of Rolaids Extra Strength Softchews, Rolaids Extra Strength Plus Gas Softchews and Rolaids Multi-Symptom Plus Anti-Gas Softchews following consumer reports of foreign-particle contamination.
• A few weeks earlier J&J recalled a dozen different Mylanta liquid products and one AlternaGEL product because they were mislabeled to omit the presence of small amount of alcohol. (Consumers don’t need to stop using the products or return them to stores.) And it separately widened a recall of daily-use contact lenses in Japan and elsewhere due to traces of an acid that can cause stinging. Contacts made in the U.S. aren’t affected.
• In November 2010 the company recalled three Tylenol Cold Multi-Symptom products, also pulled from retailers and wholesalers due to an alcohol labeling issue. Consumers can keep taking the meds, J&J says.
• Also in November the company also recalled children’s Benadryl and Motrin products. Again, J&J said they weren’t dangerous and consumers didn’t have to stop taking them.
• In October 2010, there was a recall of 127,000 bottles of Tylenol 8-Hour caplets due to a musty odor.
• In August 2010, J&J’s DePuy Orthopedics unit pulled two hip implants off the market because of an unusually high rate of replacement surgeries.
• Also in August there was a recall — later widened — of about 100,000 boxes of 1-Day Acuvue TruEye contact lenses.
• Some OTC medicines were pulled in July 2010, including varieties of Benadryl, Tylenol and Motrin. This was a follow-up to a recall of musty-smelling products made at a plant in Puerto Rico.
• In June 2010, the company widened the recall of drugs made at the Puerto Rican plant by five lots.
• The largest batch of children’s medicines were pulled in the spring of 2010.
• In late 2009 there were recalls of Tylenol Arthritis Pain Caplets due to that musty odor issue.
• J&J officially recalled batches of Motrin in July 2009, but has come under fire for an earlier so-called “phantom recall” of the product.

Again…if you have currently purchased or distributed Motrin, there are no safety concerns with the pills. So there’s no need to return used or unopened bottles. If you have any questions, reach out to your pharmacist or healthcare provider.

Contact HCC Healthcare Consultants - Pharmacy Business Solutions for help with pharmacy startup, help with pharmacy performance and efficiency or pharmacy business management service.