An editorial in the Carroll County Times (Maryland) provides some information about contaminated food that will surprise some: 300,000 are hospitalized and 5,000 die every year because of contaminated food.
Congress is now looking to give FDA the authority that most people thought they already had: to order food recalls.
Here's all the news that's fit to print:
Happy Monday!
Last week was a busy one--our firm had two trials (one continuing on this week with closing arguments tomorrow), and one that concluded very favorably with a plaintiff's verdict. But, now that I'm back, here's this week's edition of the Round-Up:
Good morning! Here are the week’s top stories:
Have a great week!
Here are this week’s stories:
Happy Monday!
Here are some stories to follow this week:
Happy Monday!
Here are the stories we’re following this week:
Happy Monday!
Here are the stories we’re following this week:
Happy Monday!
Here are the stories we’re following this week:
Happy Monday!
News reports in the past couple of days have hit on part two of the CT radiation overexposure. Before, the issue was whether certain CT devices, whether because of manufacturing, design, or technician error, provided too much radiation to patients. A secondary question was whether patients were receiving too much radiation through scans over the course of their lives (the FDA reports that the average person’s radiation exposure has doubled in the last thirty years).
Now, the question is focused on whether CT scans are a good idea for screening purposes where a patient has no indication that they have any disease—the three that have been most mentioned are whole-body CTs (to see if there is anything wrong); CT colonoscopy (to detect colon cancer), and CT scans of the heart (to detect heart disease). Most of the debate has been centered around the colonoscopy procedure.
On one side are those who believe that traditional methods—a colonoscopy, are best to detect colon cancer. Proponents (including the American College of Gastroenterology, who come out on the side of their financial interests in the question) state that CT colonoscopies are not as certain as the traditional visual colonoscopy; that removal of polyps would require a second procedure with a CT colonoscopy (versus being done at the same time in the traditional procedure), and that incidental findings on a CT scan may lead to unnecessary procedures. Additionally, repeating these scans increases patient exposure to radiation.
Detractors, those who support the “virtual colonoscopy” (including the American College of Radiology, who likewise come out on the side of their financial interests in the question) state that virtual colonoscopies are less invasive and more people will probably use them; that there is less chance of perforated bowel or anesthesia risks.
Even the FDA is undecided—there is a fight there about whether the procedure, which General Electric wants to have approved (it manufactures scanning equipment), should be approved (meaning GE would be able to market the virtual colonoscopy to patients and doctors). Some doctors and scientists believe the extra radiation exposure would cause actual harm, when even now between 1.5 and 2 percent of cancers are caused by CT scan radiation exposure.
As uncomfortable as the traditional method may be, it seems like the safest way to go. The problem with radiation exposure is that you don’t know how much you will have during your lifetime—a few major diseases, and your CT (and other) radiation exposure could magnify tenfold, meaning you might regret a virtual colonoscopy every few years. Additionally, the virtual colonoscopy, though perhaps effective to a degree, is not as certain as a traditional colonoscopy. And, peace of mind is a good thing.
To follow up on our March 2, 2010 post BigPharma Goes All “Social Media” is a website that features all comments submitted to the FDA on the social networking question. A somewhat more readable version (though, less complete) is at www.fdasm.com. Here are links to some of the heavy hitters (including law firms and internet providers) who have commented. The papers are downloadable directly from the website.
Time to wake up and face the week! Here are the stories we’re following:
Happy Monday!
Yesterday I clicked a link from @pharmaguy: End-of-Life Warning at $618,616 Makes Me Wonder Was It Worth It, an article in Bloomberg by Amanda Bennett. Don’t read it unless you have 5-10 minutes of quiet time—this is a powerful story.
This story, the story of Amanda Bennett, Terrence Bennett and their children and doctors and the U.S. healthcare system and drugs and drug companies and life and death raises a number of issues. It questions whether medical cost spending, much of which occurs in the finals days and weeks of life, is worth it. Ms. Bennett calculates that his seven-year medical bill was $618,616, discounted to $254,176. She notes that:
Would I do it all again? Absolutely. I couldn’t not do it again. But I think had he known the costs, Terence would have fought the insurers spending enough, at roughly $200,000, to vaccinate almost a quarter-million children in developing countries. That’s how he would have thought about it.
The last four days of Mr. Bennett’s life cost his insurance company $43,711. My mom, a respiratory therapist in Colorado, says that extraordinary measures and costs in the last days of life are the norm. My review of medical records and bills in my own clients' catastrophic cases confirms it.
The story also brings this to mind: though the focus of this blog is on defective drugs and medical devices, it goes without saying that drug companies and medical device manufacturers do great things. They develop products that frequently do help people to live better (if not longer), lives. Of course, our focus is on the negative 5-10% of their behavior and products (I’m just making numbers up, here. You get the idea). The majority of the time, the products are good, and the decisions are responsible. Genetech Inc. and Bayer AG paid for experimental medications for Mr. Bennett. That’s a responsible and noteworthy thing to do.
Clearly, as Dr. Ross notes in his editorial from yesterday’s post, there is a cost-benefit analysis to bringing new drugs to market and approving them. Everyone agrees to that. And, when we decide where the line is that allows some drugs and excludes others, someone is going to be unhappy. But the line has to be drawn somewhere, and we need to do it with the best information possible.
Today’s New York Times featured commentary by Dr. Gilbert Ross (maybe this Gilbert Ross?). “When Senators Play Doctor: Risk-mongering can stifle innovation, cost lives.”
Dr. Ross essentially argues that the senators have completely misinterpreted the Avandia data, whether intentionally or not, in order to fulfill their objective of creating an independent drug safety division within, but separate from, the FDA. Perhaps Dr. Ross thinks that’s a bad thing—it’s not clear from his commentary. It seems to me that, erecting another level of safety in the regulation of drugs can only be a good thing. But, that’s another blog post.
The criticism boils down to the fact that these are senators—mere politicians—who are sticking their noses where they don’t belong—in areas of science of medicine. Unfortunately, we don’t have a separate job for “scientist politicians” who can this job, so our political system is left having to deal with it as it is. Also, the senators criticizing the FDA’s handling of Avandia are undoubtedly relying on the opinions and conclusions of doctors and scientists, not the least of which is Dr. David Graham, employed by the FDA (the commentary paints him to be an anti-Pharma crusader—perhaps this is true, but perhaps he just puts patient safety a little higher on his list than others do).
Continue reading "Avandia: Much Ado About Nothing?" »
Up until now, online social networking has been treated mostly as a plaything for some pharmaceutical manufacturers. They will post a few updates on Twitter, maybe start a Facebook page or post a YouTube video or two, but I have not seen much indication that the companies have really bought in, much less that they “get it” (though, some like AstraZeneca may be playing it safe while the FDA works out the regulation aspect).
Eye on FDA has a good summary of what’s happened to get us to this point. Initially, the FDA was more concerned with the content of pharmaceutical and medical device manufacturers’ messages. However, last year the FDA realized that there is only so many contraindications you can fit in 140 characters. So, in September 2009, they took the proactive step of setting a meeting (which BigPharma interestingly did not attend), and encouraging comments (open through last month). The hope is that they will be able to draft some sort of guidelines, so everyone knows where the line is.
Continue reading "BigPharma Goes All “Social Media”" »
The FDA issued a press release Tuesday focusing on unnecessary radiation exposure from CT scans, nuclear medicine studies (use of radiopharmaceuticals taken internally creates the radiation, unlike an x-ray, which bombards the body with radiation externally) and fluoroscopy (process to see real-time moving images of internal structures).
The FDA reports that these three types of diagnostic imaging use ionizing radiation, which can increase lifetime cancer risks. Single exposure to high levels of ionizing radiation causes hair loss, skin burns and cataracts.
The FDA recommends two areas to minimize radiation risk:
One of the most important parts of this process is, of course, the patients. Patients should discuss the risks of any procedure involving radiation with their doctors. The FDA is working to develop a patient medical imaging history card, which (if used properly) will better enable physicians to understand the lifetime radiation history of patients, and enable them to better inform patients as to the real risks of subsequent exposure.
The press release focused mostly on the CT images and fluoroscopy, and did not seem to address the procedures for radiopharmaceuticals (nuclear medicine studies), though perhaps that is subsumed in the section on protocols for health care providers who perform imaging services. But, the manufacturers of those pharmaceuticals should also be part of the discussion.
Here are links to some stories we’re following:
Happy February!
Instead of doing our usual Monday Drug Blog Round-Up yesterday, we opted for a fuller post on the recent plaintiffs’ pain pump victory in Oregon. For more on that story, see the Oregonian. So, today we’ll bring you the links to the stories we’re following:
Happy Tuesday!
Bisphenol-A (BPA) is a chemical used in production of polycarbonate plastics and epoxy resins, and until recently it featured largely in baby bottles. In 2008, the public consciousness was flooded with reports that BPA leeches from bottles into liquid (more or less, depending on the temperature of the liquid). Other reports have indicated the potentially dangerous effects of BPA. In April of 2008 the National Toxicology Program’s Center for the Evaluation of Risks to Human Reproduction (part of the National Institutes of Health) drafted a brief concluding that exposure may affect human development (including early puberty, prostate gland changes, behavioral changes) or reproduction.
The concern for babies is that they have potentially the highest BPA intake—on a pound-for-pound basis, they consume more than adults and additionally suck on plastic items that increases the risk of exposure. In rodent tests, there is evidence that young animals cannot metabolize the chemical as efficiently, and therefore have higher concentrations in their blood.
While the FDA was initially lukewarm about BPA concerns, it has raised the temperature of its response by announcing last week that “on the basis of results from recent studies using novel approaches to test for subtle effects, both the National Toxicology Program at the National Institutes of Health and FDA have some concern about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children.” Read the full FDA update here.
Other studies, however, have refuted any harmful causes of BPA, including one from the Environmental Protection Agency.
On the litigation front, MDL 1967: In Re: Bisphenol-A (BPA) Polycarbonate Plastic Products Liability Litigation was transferred to the U.S. District Court for the Western District of Missouri (Judge Ortrie D. Smith) on August 13, 2008. The allegations against bottle manufacturers and baby formula manufacturers (retailers were dismissed) at time of transfer were that BPA is toxic, and may cause cancer. In November of last year, the judge dismissed all of the formula defendants and ordered the parties to submit dates for completion of discovery, filing of motions for class certification, and other motions.
Whether this is overly paranoid or not, most people (especially parents) are taking the safe road, and avoiding baby products containing BPA.
A number of news outlets have reported Ralph Tyler’s switch as Maryland insurance commissioner head of the Maryland Insurance Administration to his new position as top dog in the FDA’s legal department (Law.com, Maryland Lawyer Blog, Maryland Daily Record and FDA Law Blog).
While in his post as the insurance commish for Maryland (since September 2007) he fought over the compensation package for CareFirst BlueCross BlueShield’s former CEO, William Jew. Tyler cut the compensation down from $18 million to about $9 million (that decision was overturned by the Baltimore County Circuit Court in November—the agency has filed a notice of appeal). He also managed to return about $100 million ($13.8 million to the doctor-policyholders, and $84.1 million to the state of Maryland to make up for subsidies that slowed years of malpractice insurance rates) from Medical Mutual Liability Insurance Society of Maryland. To much fanfare in Maryland, he helped to crush a proposed 72% rate increase by Baltimore Gas & Electric.
But, he left all of that behind last week, and is expected to formally start at the FDA on January 19, replacing interim General Counsel Mike Landa. No word yet on what Tyler’s plans for the FDA are—at this point, he states that he is planning to assess the agency’s needs, and go from there. He’s a smart guy, and he has a good track record—I’m sure the FDA and consumers of drugs and medical devices will be well-served.
