Author Archive
Levaquin Sales Rep in Need of Auctioneer Training?
January 4th, 2011. By Hunter West
The recent victory by a Levaquin plaintiff in his lawsuit against the manufacturer of the fluroquinolone antibiotic raises an interesting sidebar.
Earlier this month John Schedin was awarded more than a million dollars by a jury, after he suffered ruptures in both his Achilles tendons three days after starting on Levaquin together with a steroid. The doctor who prescribed the duo to the then-76-year-old indicated that while he was aware of the potential for tendon complications with Levaquin, he was not aware of the increased risk to seniors when Levaquin is taken in concert with a steroid.
Schedin now has to crawl up the stairs on his hands and knees in order to get to his bed at night. His doctor is mortified at the role he played in his patient’s misfortune.
The trial featured the usual back-and-forth as to what was known and what wasn’t, what was revealed and what allegedly was not, and so on. The manufacturer (defendant) claims that all the necessary info was made available on the medication guide that came with the product. The plaintiff countered that such information—including the black box warning—was buried deep within the bowels of a document few patients will ever read anyway, let alone their busy doctors.
The doctor testified that he did not recall the manufacturer’s rep ever referencing tendon problems during her visits to the office. The sales rep, while testifying she did slip an information packet into the basket with all the free samples, did not recall either whether, or not, she had made any verbal reference to the Levaquin tendon issue.
However, she said, she may not have had time anyway. She testified that in this day and age, with high caseloads, getting to actually talk to the doctor for 30 seconds would leave her feeling ‘lucky…’
Thirty seconds?
Something is wrong here.
How can a drug company rep effectively disseminate product information to a doctor in that Read the rest of this entry »
Score One for the FDA as Rest of World Finally Yanks Thelin
January 3rd, 2011. By Hunter West
Time to give credit where credit is due. And this time, the US Food and Drug Administration (FDA) got it right.
Recently it was announced, in a joint statement by Health Canada and Pfizer Canada, that Thelin (sitaxsentan) was being taken off the market in Canada, as well as every country in which it had been sold, due to risk for potentially fatal liver damage.
Never heard of Thelin? There’s a reason for that. Thelin is not available in the US. Never was. That’s because the FDA refused to approve the drug designed to treat pulmonary hypertension. In the view of the FDA, the benefits did not outweigh the risks.
In a bid to win FDA approval for marketing Thelin in this country, Pfizer Inc. launched a series of clinical trials. However, those trials have been abandoned following the deaths of three trial participants.
According to a report in the Globe and Mail, Canada’s national newspaper, liver damage was a known complication of Thelin. However, in announcing that it was abandoning further clinical trials, Pfizer noted that it had discovered a “new potentially life-threatening idiosyncratic risk” of liver injury among patients that is difficult to predict or guard against.
Thus, there will be no further clinical trials, and Thelin will be coming off the market in Australia, Europe and Canada where it had been previously approved. Given the known risks associated with Thelin, Canadians are wondering how Thelin ever won Health Canada approval in the first place.
The FDA has been maligned, chastised, ridiculed and kicked to the curb over the appearance of lax oversight both in the approval, and ongoing supervision of drugs and medical devices. And to be sure, much of that criticism is warranted.
However, on this occasion the FDA stuck to its guns and has been vindicated. There can be Read the rest of this entry »
BPA on Cash: Reason to Give Your Daughter The Credit Card
December 21st, 2010. By Hunter West
It’s enough to make you want to give your daughter the credit card.
“Here…please…TAKE it…don’t spend your cash.”
That’s because a recent study has found that Bisphenol A (BPA) can now be found on paper money.
Not that your dollar bills are manufactured with BPA. But researchers are suggesting that the BPA found on some cash register receipts is rubbing off onto paper money.
There is some debate as to whether, or not this is really harmful, however…
For example, Kathryn St. John, a BPA specialist with the American Chemistry Council noted in comments to CNN earlier this month that BPA levels in some thermal papers are low, and research shows that it’s safe.
“To the limited extent BPA is absorbed through the skin, it is converted to a biologically inactive metabolite that is rapidly eliminated from the body,” St. John said.
“Biomonitoring data from the US Centers for Disease Control shows that consumer exposure to BPA, which would include any exposure from receipts, is extremely low. Typical exposure from all sources is about 1,000 times below safe intake levels set by government bodies in Europe and the US In comparison, the trace levels of BPA claimed to be present in dollar bills are insignificant.”
But critics aren’t so sure—and lately they’ve been getting some vindication from the likes of the US Food and Drug Administration (FDA), which issued a statement earlier this year admitting that recent studies “provide reason for some concern about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants and children.”
Ericka Schreder, a staff Scientist with the Washington Toxics Coalition (WTC) and author of the report “On The Money: BPA on Dollar Bills and Receipts” that was also published by Safer Chemicals, Healthy Families, noted that it only takes ten seconds for BPA to transfer to skin from a cash receipt.
In other words, the time it takes for you to accept the receipt and either jam it in your pocket or, like most people, fold it up and stuff it into your wallet or purse. You now have BPA on your hands.
What’s more, if that receipt is stuffed in along with your paper money, you now have BPA on your money, too.
“Levels on dollar bills were lower than on receipts, but the fact that our currency is contaminated with a hormone-disrupting chemical illustrates how our current chemical law is failing us,” Schreder says. “Even the most careful consumer can’t avoid BPA when it’s so pervasive that it even contaminates money.”
BPA has been linked to everything from cancer, to early puberty. The National Institute of Environmental Health Sciences at the National Institutes of Health previously noted that 93 percent of urine samples from individuals over the age of six years exhibit detectable levels of BPA.
While research linking BPA to specific health problems remains inconclusive, most agree that an update to the 1976 Toxic Substances Control Act is long overdue.
Schreder says the Act needs to be replaced with a new chemical law requiring companies to “provide health information on chemicals they produce and ensure chemicals that can cause cancer, infertility, and other health problems can’t be used in everyday products.”
Bottom line? There is BPA on a lot of cash receipts. Now there is BPA on cash. While the jury is still out on just how harmful BPA is (if it is at all), a precaution might be to park the cash and use the plastic more.
That includes your teenage daughter. Let’s just hope you can afford it…
Should the FDA Share Some of the Blame on DePuy?
December 14th, 2010. By Hunter West
Earlier this month it was announced that all pretrial proceedings for lawsuits centered on the recalled DePuy hip replacement system, will be heard before a single judge in Toledo.
While there are about 150 lawsuits so far, those in the know expect that number to grow to well beyond 1,000. More than 30,000 patients in the US received the complete DePuy hip replacement system that is seen to be failing in a large number of cases, since it was approved by the US Food and Drug Administration (FDA) in 2005.
- Surely Billy Joel expects his hip replacements to last more than 5 years…
I’ll get back to the FDA in a moment. But imagine, if you will, the frustration borne by hip replacement patients realizing that medical products designed to last 20 years, are failing after only a few.
Let’s remember that individuals who are getting hips now, are by and large more active than our fathers and grandfathers at a similar age. We’re not ready for the nursing homes at 50, or 60 or even 70. There are people who are running, skiing, even competing in various sports well into their 80s.
For the remainder of us not inclined toward athletic pursuits, we remain by and large much more active than our forefathers.
Look at Billy Joel. He is still a relatively young man at 61, is he not? In the last two weeks he received a double hip replacement. We fully expect to see him dancing up there on the stage in no time, and I’m sure he expects to have that capacity for the next 20 years if he so chooses.
That’s the point—the expectation. Twenty years is the expectation.
Not five.
So pity the patient, in his 50s who receives a hip and rather than the promised 20-year lifespan, is met instead with pain and suffering, together with a second surgery just a few years on.
Little wonder the expectation is for so many lawsuits over the recalled DePuy system.
That said, I hope the FDA gets some of the blame…
Here’s why.
Our country’s great overseer of all things drug and medicinal employs this little-known rule Read the rest of this entry »
Elective Surgery Risks Include Wallet Suction
December 8th, 2010. By Hunter West
Medical credit cards…
- Charge it…but more than the fat may be missing post-op
Have you heard about these things?
They’re designed for those elective procedures not covered by health insurance or Medicaid. It might even be a procedure you don’t even really need, such as laser eye surgery, or cosmetic dentistry. A facelift.
You may not have the money for it. And you may not have the room on your existing credit cards. But now you can apply for a medical credit card issued by a number of providers with the express use of funding medical procedures.
But buyer beware…
As a recent article in The New York Times points out, medical credit cards can dig you into an even deeper financial hole if you’re not careful. The other problem, according to the November 26th issue of Patient Money in The New York Times, is that such cards have been designed, Read the rest of this entry »
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