Johnson & Johnson is waiting to hear whether or not a judge in Ohio will allow any lawsuits over its Ortho birth control patch to move forward, and the New York Times says lawyers on both sides think there’s a good chance he may find in the company’s favor based on the doctrine of pre-emption. The argument goes that it’s the FDA’s responsibility to monitor the safety and labeling of drugs that go to market, and therefore if something goes wrong, it’s the agency’s fault and not the pharmaceutical company’s.
Pre-Emption Doctrine Would Make FDA Responsible For All Drug Problems, Shield Big Pharma From Lawsuits
Tina claims that last December she had her prescription filled at a Dallas Walgreens store, and was surprised to see that the pills had changed.
The Prescription Access Litigation (PAL) coalition filed suit against 11 drug companies in 2002 for artificially inflating the average wholesale price, or AWP, of certain drugs, including ones used to treat serious illnesses such as cancer and HIV. This week, PAL announced that the companies have agreed to pay $125 million to settle—82.5% of the amount will be used to compensate third-party payor’s claims, and the remaining 17.5% will be used for consumer claims. Here’s a list of the drugs involved, and after the jump is a quick guide to see whether you’ll qualify for a claim, pending the judge’s approval of the settlement.
The U.S. Institute of Medicine called on Congress today to “establish a single national resource of health information.” The resource would collect all available data on every drug in the marketplace, and be available to consumers to educate themselves about any and all possible treatments in order to make better-informed decisions with their doctors.
A clinical trial of Zetia, a popularly prescribed cholesterol-lowering drug, “failed to show that the drug has any medical benefits.” In fact, fatty plaques grew almost twice as fast in patients who took Zetia along with Zocor in a combo product called Vytorin. However, “patients who are taking Vytorin or Zetia should talk to their doctors if they are concerned and not discontinue taking the medicines on their own.” [New York Times]
Two former sales reps for the pharmaceutical company Amgen are suing “for lost wages and other compensation after refusing to participate in improper promotion of the company’s blockbuster psoriasis drug Enbrel.” They claim that Amgen encouraged them to “illegally access patient records to induce insurance carriers to pay for the pricey drug,” according to their attorney. Amgen promptly responded that the suits were without merit, and then handed out blister packets of popular drugs, branded desk calendars, and free t-shirts, so everything’s cool.
It’s okay for drug companies to spend oodles on advertising because they spend even more making sure their drugs are safe and effective, right? Not so much, according to a study in PLOS Medicine.
Bayer is recalling certain diabetes test strips because they tend to over-report blood glucose level readings by 5 to 17 percent. Affected lots begin with WK7 and then either a D, E, F or G. All other lot numbers are fine and can be used. More information.
The FDA said today that a small number of preventable cases of accidental death have occurred since their first Duragesic warning in 2005, prompting them to ask Johnson & Johnson and the makers of a generic version to add new warnings. “Despite a July 2005 warning, the Food and Drug Administration ‘has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or patients have incorrectly used it,’ the agency said.”
This week, an FDA advisory panel will review a recommendation to put a warning on flu drugs Tamiflu and Relenza that says there have been “psychiatric events observed in some patients.” The companies who make the drugs have both responded that they’ve found no causal link between their drugs and “psychiatric events.”
A new study from the University of California at San Diego School of Medicine suggests that simvastatin, also known as the cholesterol-lowering drug Zocor, may interfere with sleep patterns: “people who took the statin drug Zocor or simvastatin found they had significantly worse sleep quality compared with people who took Pravachol or pravastatin, another cholesterol-lowering drug.” Simvastatin is fat soluble, which means it can more easily penetrate cell membranes and mess with brain chemistry.
The Reuters headline is so perfect, we can’t improve upon it. Hide your old pills in poop, folks, before you discard them, especially ones that are frequently abused like the painkillers oxycodone, morphine, and fentanyl, and the stimulant methylphenidate.
The health blog at the New York Times points out that there are all sorts of behavioral changes you can adopt to fight insomnia that have been proven to work—they just sound so ordinary and common that people either don’t think they’re effective or assume pills will work better.
The Chinese government has discovered a fake diabetes medicine on a fake research institute website, which then links to a fake version of the official government health and drug watchdog agency’s site. If you’re paying attention to urls, it’s hard to not notice that something’s wrong—but we’re sure there’s more than enough people who don’t notice that little detail.
Pfizer is in panic mode about its rapid decline in Lipitor sales—in the last 18 months, it has dropped from 40% of the market for cholesterol-lowering drugs to 30%, and likely to drop further—so it’s launched a big media-blitz to convince people not to switch to simvastatin, the generic version of its name-brand competitor, Zocor. Zocor was more expensive than Lipitor, so Pfizer had nothing to worry about for years—but then Zocor lost its patent protection last year, and now doctors are switching patients from Lipitor over to Zocor’s generic twin to save money.
Stop doing that or you’ll go deaf! That’s the new warning (sort of) the FDA will require on popular anti-impotence drugs, spurred after a published report of a man who suffered sudden hearing loss after taking Viagra. The FDA took a look at side effect data and found 29 cases since 1996 where men suffered from similar hearing loss after taking one of the three drugs. “In two thirds of the cases, the hearing loss was ongoing, the agency said.” A drug to treat pulmonary hypertension, Revatio, will also receive the warning because it contains the same ingredient as Viagra.
Too many patients don’t remember the names of the medications they’re on, posing problems for doctors who are trying to treat them, warn researchers at Northwestern University’s Feinberg School of Medicine in Chicago. About 40% of the patients surveyed “could not accurately recall what drugs they were taking,” and among those with “low health literacy,” the rate jumped to 60%.
Zyprexa, Lilly’s best-selling drug to treat schizophrenia, has been shown to cause “cause weight gain, high blood sugar, high cholesterol and other metabolic problems,” but until now, the company has refused to add any warnings about these side effects to the label. Now, sparked in part by lower sales, Lilly has announced that Zyprexa will warn consumers that it can cause high blood sugar. The American Diabetes Association claims that Zyprexa causes diabetes, but this isn’t addressed on the new warning labels.