September 7, 2010
by Ethan A. Huff
Johnson & Johnson (J&J) is the subject of a California lawsuit alleging that the “family company” colluded with pharmaceutical consultant Omnicare to push its drugs on nursing home residents. Among the charges are allegations that J&J violated federal Medicaid laws with its schemes to maximize profits.
According to the suit, J&J was paying kickbacks to Omnicare to promote its drugs above those of other manufacturers, and convincing doctors that switching to J&J drugs was in their patients’ best interests. The arrangement also included whitewashing these kickbacks as “performance rebates” that would be issued as “year-end bonuses.”
“Residents were overcharged for their medications, had additional medications administered and were unlawfully switched to Johnson & Johnson drugs,” explains the lawsuit. These medications included Floxin, Levaquin, Risperdal, Ultram, Duragesic, Procrit and Aciphex.
During their joint meetings to discuss “performance goals,” J&J allegedly trained Omnicare employees to use “scripted communications” to convince physicians to switch their patients to J&J drugs as opposed to whatever they were currently on. This was included as part of the J&J’s “Active Intervention Program,” which basically is just a fancy name pushing its drugs on seniors.
J&J even went out of its way to bypass federal laws that protect the interests of the Medicaid program. Medicaid provisions include a “best price law” that is designed to keep costs low for Medicaid reimbursement and when drug discounts and rebates exceed a certain threshold, the drug company would have to then pass those on to Medicaid. But J&J is said to have worked with Omnicare to develop a scheme to avoid this threshold.
If the threshold was breached, Omnicare would have to initiate a retroactive price adjustment in order not to lose its kickback. So the company participated with J&J to make sure that didn’t happen.
If the allegations are true, J&J has demonstrated itself to be unscrupulous in its business practice, willing to do whatever it takes to rake in the highest profit. Not only this, it will also have violated federal law.
The class-action suit includes two groups of patients: those nationwide and those specifically in the state of California. Any nursing home patients who received drugs or services under Omnicare between April 1, 1997, and the present are eligible to participate in the suit.
Even eligible patients who have since passed away can have their estate included in the suit.
May 26, 2010
By Steven Reinberg
Blockbuster heartburn medications such as Prevacid, Prilosec and Nexium will now carry a warning on their labels linking the drugs to a heightened risk for fractures, the U.S. Food and Drug Administration announced late Tuesday.
The label will advise consumers to use this class of medicines, called proton pump inhibitors (PPIs), carefully, because high doses have been associated with an increased risk of fractures of the hip, wrist and spine, the agency said.
PPIs, which include prescription and over-the-counter drugs, work by blocking stomach acid from being produced. However, as with any drug, this benefit comes with some risk, the FDA said.
“Epidemiology studies suggest a possible increased risk of bone fractures with the use of proton pump inhibitors for one year or longer, or at high doses,” Dr. Joyce Korvick, deputy director for safety in FDA’s Division of Gastroenterology Products, said in an agency statement.
“Because these products are used by a great number of people, it’s important for the public to be aware of this possible increased risk and, when prescribing proton pump inhibitors, health care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient’s condition,” she said.
Based on a review of the scientific evidence, the agency is instructing the makers of the drugs to change the labels for both the prescription and the over-the-counter versions of the proton pump inhibitors. The FDA based its decision on the results of seven studies, six of which noted a link between PPIs and fracture, primarily among users aged 50 and over.
Proton pump inhibitors include the drugs esomeprazole (Nexium)), dexlansoprazole (Dexilant), omeprazole (Prilosec, Zegerid)), lansoprazole (Prevacid)), pantoprazole (Protonix)), and rabeprazole (Aciphex)). These medicines are used to treat gastroesophageal reflux disease (GERD), stomach and small intestine ulcers and inflammation of the esophagus. Over-the-counter versions of Prevacid, Prilosec and Zegerid also fall into this class of drugs.
The FDA is advising consumers to not stop taking PPIs until they have consulted with their doctor. However, patients should be aware of the increased risk for fractures. The highest risk was seen in people taking higher doses of PPIs, or among those who took them for a year or more, the agency said.
For people taking over-the-counter proton pump inhibitors, the FDA said they should only be taken for 14 days to help ease frequent heartburn. If heartburn continues, people should see their doctor. Under no circumstances should over-the-counter PPIs be taken for more than three 14-day periods in a year, the agency said.
Dr. Amar R. Deshpande, an assistant professor of gastroenterology at the University of Miami Miller School of Medicine, said the data behind the FDA decision “is not new.”
PPIs may disrupt the body’s ability to absorb calcium, which, in turn, can increase the risk for fractures, Deshpande explained. He also believes that this class of drugs is overused and often taken by patients for too long.
There’s a need to “be judicious in general, irrespective of this data,” Deshpande said. “With PPIs we should really have a targeted endpoint to come off these medications. There is more reason to do that now that we are seeing data that they can have potential side effects.”
It is probably also a good idea to shy away from high doses of the heartburn medications, unless absolutely necessary, he said.
“Everything in medicine is a risk/benefit ratio,” Deshpande said. “Patients need to talk to their doctor about what they are on the PPI for and look at the risk/benefit ratio and see if they should be on it indefinitely or should be able to come off the PPI.”
May 11, 2010
By Daniel J. DeNoon
The popular class of antacids that includes Aciphex, Dexilant, Nexium, Prevacid, Prilosec, and Protonix increases the risk of C. diff infection and bone fracture, new studies find.
The drugs all are proton pump inhibitors (PPIs), the most powerful class of antacid drugs. It’s the third highest-selling class of drugs in the U.S. Each year, doctors write 113.4 million prescriptions for the drugs. Two, Prevacid and Prilosec, are available without prescription.
The drugs do a great job of reducing stomach acid. They’re not only far more powerful than simple antacids (such as Maalox, Rolaids, and Tums) but also reduce stomach acid more than the H2RA drugs Axid, Pepcid, Tagamet, and Zantac.
PPIs are supposed to be used only for serious conditions, but often they are taken for simple heartburn. Moreover, doctors tend to overprescribe PPIs for hospitalized patients. What’s the harm?
More than many patients should risk, according to a series of articles in the May 10 issue of Archives of Internal Medicine.
April 13, 2010
by Jon Hood
A lawsuit filed last week accuses Johnson & Johnson of conspiring with pharmaceutical consultant Omnicare in an effort to push J&J drugs on nursing home residents, and violating federal Medicaid laws in the process.
As a result of the scheme, “residents were overcharged for their medications, had additional medications administered and were unlawfully switched to Johnson & Johnson drugs,” all in the name of increasing revenue, according to the lawsuit.
The suit, filed in federal court in California, says Omnicare — which “occupies a ‘dual’ role of a dispensing pharmacy and consulting pharmacy” — gave certain J&J drugs “elevated status as the default drug of choice” for thousands of nursing home patients. J&J allegedly gave Omnicare “performance rebates” — essentially kickbacks — in return for its services. This arrangement was memorialized in a 1997 “Supply Agreement” between the two companies, the suit states.
The agreement provided that the two companies would “meet quarterly to review their joint ‘business plan’ and ‘performance goals,’” and came up with a novel way to deal with the performance-rebates: they would be treated as year-end bonuses.
The drugs allegedly targeted for promotion under the agreement included Floxin, Levaquin, Risperdal, Ultram, Duragesic, Procrit, and Aciphex.
The suit contends that under the agreement, J&J paid to have its drugs labeled as “preferred” — a status that Omnicare purportedly confers on drugs that receive high marks “for their clinical effectiveness in the geriatric community.”
In an effort to distribute as many J&J drugs as possible, Omnicare allegedly encouraged nursing home physicians to use a so-called “Active Intervention Program” to push J&J drugs on seniors. The program “was designed to ‘shift market share’ to Johnson & Johnson from other pharmaceutical manufacturers.”
For patients on antipsychotic drugs, Omnicare’s pharmacists were even given hypothetical “scripted communications [to have] with the prescribing physicians under various scenarios,” intended to convince the physicians that switching to Risperdal — a J&J-manufactured antipsychotic — was in the patient’s best interest.
According to the suit, the companies also came up with a way to get around Medicaid’s “best price law,” a federal statute intended to ensure that Medicaid pays as little as possible for prescription drugs. Under the law, once the discounts and rebates exceeded a certain level, the companies would have been required to pass them along to Medicaid.
Once that threshold was breached, “the Supply Agreement required a retroactive price adjustment” to avoid losing the kickback. The suit also alleges that J&J and Omnicare developed several other complex schemes designed to avoid breaching the best price threshold.
The suit defines two potential classes, one national and one consisting only of California residents. In either event, the class would consist of nursing home residents who received drugs or services from Omnicare, and who paid for and received one or more of an enumerated list of drugs.
The class period stretches from April 1, 1997 to the present. If an eligible class member has passed away, his or her estate would be eligible for inclusion in the class.
By S.L. Baker
Prilosec, Nexium, Prevacid, Aciphex. These and a dozen more drugs known as proton pump inhibitors (PPIs) have quickly become superstars of Big Pharma. As recently reported by US News and World Report, last year people worldwide shelled out some $ 25.6 billion for these drugs that are supposed to alleviate heartburn and gastroesophageal reflux disease (GERD). Although hailed by most doctors as safe, reports have started cropping up that side effects may include everything from dizziness to osteoporosis, increased risk of heart attacks, pneumonia and more.
Now comes research that shows the drugs actually cause the symptoms they are supposed to treat. A new study just published in Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute, found that taking a PPI drug for eight weeks induced acid-related symptoms including heartburn, acid regurgitation and dyspepsia in healthy individuals soon after they stopped taking the pills.
“The observation that more than 40 percent of healthy volunteers, who have never been bothered by heartburn, acid regurgitation or dyspepsia, develop such symptoms in the weeks after cessation of PPIs is remarkable and has potentially important clinical and economic implications,” Christina Reimer, MD, of Copenhagen University and lead author of the study, said in a statement to the media. “This study indicates unrecognized aspects of PPI withdrawal and is a very strong indication of a clinically significant acid rebound phenomenon that needs to be investigated in proper patient populations.”
In the randomized double-blind placebo-controlled trial, the scientists investigated whether long-term treatment with a PPI could cause a dependency state. Specifically, they wanted to see if patients would need non-stop, continuous treatment with the drugs due to rebound acid hypersecretion when the medications were stopped. In all, 120 healthy participants were randomized to about three months of taking inactive placebo pills or 40 mg. of the PPI drug esomeprazole (brand names: Nexium, Esotrex) daily. This was followed by having all the research subjects take a placebo for another four weeks. A Gastrointestinal Symptom Rating Scale (GSRS) was filled out weekly by those participating in the study.
During the first two weeks after withdrawal of the PPI, the majority of research participants began to have mild to moderate indigestion discomfort. What’s more, the GSRS scores for acid-related symptoms were significantly higher in the PPI group during weeks 10, 11 and 12 of the study. In fact, 44 percent of the people taking the PPI experienced at least one worrisome acid-related symptom in weeks nine through 12 compared to only 15 percent in the control taking placebo pills. About 22 percent of people in the PPI group complained of dyspepsia, heartburn or acid regurgitation in week 10 and 11; around 21 percent of the research subjects had indigestion problems in week 12 of the study. However, those in the placebo group reported indigestion and reflux symptoms at a far lower rate. Only about seven, five and two percent of them had heartburn or other related problems during weeks 10, 11 and 12 of the study.
“We find it highly likely that the symptoms observed in this trial are caused by rebound acid hypersecretion and that this phenomenon is equally relevant in patients treated long term with PPIs. If rebound acid hypersecretion induces acid-related symptoms, this might lead to PPI dependency. Our results justify the speculation that PPI dependency could be one of the explanations for the rapidly and continuously increasing use of PPIs,” Dr. Reimer stated.
In the media statement, the researchers noted previous research has have shown that about 33 percent of patients who start taking PPI drugs keep on refilling their prescriptions. So why do they need maintenance therapy if these drugs are supposed to successfully treat GERD and related conditions? Reimer’s research strongly indicates it’s because when people try to stop taking PPIs, they experience an increase in gastric acid secretion that soars beyond their pre-treatment levels. Within two weeks after withdrawal from treatment, they experience even worse heartburn, regurgitation and other GERD symptoms than ever — so they have to go right back on the expensive PPI drug therapy.