November 2009

I sure hope so.  Because the ability of pharmaceuticals to find out how often doctors prescribe which medications allows those pharmaceuticals to engage in all sorts of shenanigans, like finding doctors open to ghostwriting and pushing for off-label prescription use.

Washington Bureau – When your doctors writes you a prescription, that’s just between you, your doctor, and maybe your health insurance company–right?
Wrong. As things stand now, the pharmaceutical companies that make those prescription drugs are also looking over the doctor’s shoulder, keeping track of how many prescriptions for whose drugs the individual physician is writing.

And that data on the prescribing habits of thousands of doctors has become a powerful sales and marketing tool for the pharmaceutical industry, but also a source of growing concern among some elected officials, healthcare advocates and legal authorities.

Source: States, Consumer Advocates Challenge Rx Data Mining — baltimoresun.com

Lawsuits over the drug Reglan (Metoclopramide) fascinate me because of the unique nature of the disorders the drug can cause.  Reglan can cause movement disorders like tardive dyskinesia.  Individuals suffering from these disorders lose control of their facial muscles and their limbs.  It’s incredibly strange to me that temporary use of this drug can cause someone to permanently develop movement disorders.

Below you’ll find an assortment of documents filed in Reglan lawsuits from around the country.  If you’d like me to put you in touch with a Reglan lawyer, feel free to email me at justinian at justinian dot us, or use the form to the right.

I agree that visits to China should be at the top of the FDA priority list.  I’m not sure about increasing the speed of drug reviews, though, unless that speed increase comes from increased staff.  Asking existing staff to do more in less time is a recipe for another Vioxx disaster.

NEW YORK (Reuters) – The U.S. Food and Drug Administration is working to increase the speed of drug reviews and clean up problems in the division that oversees medical devices, the agency’s commissioner said on Thursday.

Dr. Margaret Hamburg, speaking at the Reuters Health Summit in New York, also said visiting China to discuss the safety of imported products was a top priority for her in 2010.

Source: FDA head to speed reviews, visit China | Industry Summits | Reuters

As always, consult your doctor before you even think about taking yourself off a drug.

WASHINGTON -(Dow Jones)- The Food and Drug Administration Friday said it was conducting a safety review of the weight-loss drug Meridia, which is made by Abbott Laboratories (ABT).

The FDA siad it was reviewing preliminary data from a recent study that suggests patients using the drug have a higher number of cardiovascular events such as heart attacks and strokes compared to patients not on the drug.

Source: FDA Reviewing Safety Of Weight-Loss Drug Meridia

There are many lawsuits pending against Merck over its drug Fosamax.  There is evidence that the drug causes necrosis of the jaw.  I’ve seen pictures of people with this disease, and they look like normal people with the jaw of a rotting corpse.  It’s a terrible, horrible disease.  At this time, I don’t know of any attorneys actively taking Fosamax cases.  One of the reasons why is that there haven’t been any trials against Merck yet.  When the first trial hits, the verdict in it will likely influence whether attorneys will pursue more Fosamax cases.

Wyeth and its new parent Pfizer are probably wishing they had more to be thankful for this week, after being hit with jury awards totaling $103 million over hormone drugs. But what started out as a tough week for Big Pharma got a little better late Monday, when Manhattan federal District Court Judge John Keenan dismissed the second of three bellwether cases facing Merck over its osteoporosis drug Fosamax just weeks before it was set for trial.

Source: Law.com – Merck Knocks Out Second Fosamax Test Case Before Trial

These employees are charged with reviewing applications to market new drugs.  Obviously, the more training they get, the better.  (And if you didn’t know, it’s pronounce Dookane.)

Duquesne University will have a hand in the training of federal employees charged with reviewing pharmaceuticals, as part of a consortium of schools that won a two-year $652,000 U. S. Food and Drug Administration contract.

Source: Duquesne University to share FDA contract – Pittsburgh Business Times:

This is fresh from the FDA.  If you’re using Meridia (Sibutramine) you may want to bring this up with your doctor:

FDA notified healthcare professionals and patients that it is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo (sugar pill). Sibutramine is marketed as Meridia, a prescription drug, in the United States. Meridia was approved by FDA in 1997 for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with a reduced calorie diet. Meridia is only recommended for obese patients with an initial body mass index (BMI) ≥ 30 kg/m2, or BMI ≥ 27 kg/m2 with other risk factors (e.g., diabetes, high cholesterol, controlled high blood pressure).The analysis of these data is ongoing and FDA is making no conclusions about the preliminary findings at this time. These findings highlight the importance of avoiding the use of sibutramine in patients with a history of coronary artery disease (heart disease), congestive heart failure (CHF), arrhythmias, or stroke, as recommended in the current sibutramine labeling.

Read the MedWatch safety summary, including a link to the FDA Early Communication about an Ongoing Safety Review, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191655.htm

Notice I said to bring it up with your doctor: N E V E R stop using medication without first talking it over with your doctor.

Unfortunately, I had the opportunity to view some of the evidence against AMO in this case.  That evidence included graphic depictions of those who have lost their eyes or been forced to undergo eye surgery due to infections developed while using this solution.  (shudder)  Here’s some news about a class action lawsuit relating to the solution.

Six months after the California Supreme Court lowered standing requirements for consumer class actions, a state trial judge has certified a class of consumers who purchased contact lens solution linked to an infection that can cause blindness.

Orange County, Calif., Superior Court Judge David C. Velasquez ruled on Nov. 12 against Abbott Medical Optics Inc., formerly Advanced Medical Optics Inc.

Plaintiffs attorney Mark Robinson, senior partner at Robinson, Calcagnie & Robinson in Newport Beach, Calif., credited the certification order to the California Supreme Court's May 18 decision in In re Tobacco II Cases. That ruling resolved a legal dispute over Proposition 64, a 2004 ballot initiative designed to curb consumer cases filed under California's unfair competition law by requiring that plaintiffs show actual injury. In that case, in which Robinson represented tobacco smokers, the California Supreme Court said that class actions alleging consumer fraud can go forward even if not all the class members have suffered injuries caused by deceptive advertising.

Before In re Tobacco II, class certification in the Abbott case appeared destined for failure, Robinson said.

Source: Law.com – Calif. Contact-Lens Solution Class Is Certified

One area I haven’t written much about yet is the association of chrondrolysis with drugs used in certain shoulder pain pumps.  Here’s some fresh information on that topic from the FDA:

FDA notified healthcare professionals of 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices to control post-surgical pain. The local anesthetics (with and without epinephrine) were infused for extended periods of time (48 to 72 hours) directly into the intra-articular space using an elastomeric pump. Joint pain, stiffness, and loss of motion were reported as early as the second month after receiving the infusion. In more than half of these reports, the patients required additional surgery, including arthroscopy or arthroplasty (joint replacement).

Local anesthetics are approved as injections for the production of local or regional anesthesia or analgesia. The approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as elastomeric pumps. The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics. Health care professionals are encouraged to follow the instructions for use of elastomeric infusion devices, and to not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery.

This notice provides further management considerations for healthcare professionals, information for patients, a data summary of the 35 reports, and references.

Read the complete MedWatch 2009 Safety summary, including a link to the Information for Healthcare Professionals sheet, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190496.htm

This sounds like a fantastic idea to me.

WASHINGTON, Nov 9 (Reuters) – A drug industry group on Monday urged the U.S. Food and Drug Administration to adopt a universal safety symbol for Internet content containing FDA-approved information about a medicine or medical device.

The proposal from the Pharmaceutical Research and Manufacturers of America, which represents some of the biggest drug makers in the world, came ahead of an FDA public meeting this week on how FDA-regulated prescription drugs and medical devices are promoted in social media and on the Internet.

PhRMA said the logo would be coupled with a link leading Web users to FDA-regulated information about the device or drug. Whether that link would go to the FDA’s or drug maker’s site or another forum is up for debate

Source: US drugmakers urge FDA safety logo for Internet | Industries | Technology, Media & Telecommunications | Reuters

My personal preference is for the link to go to the FDA web site, although I’d be OK with it going to the drugmaker if they had to keep the linked page up for as long as the drug is on the market.