The Latest Avandia Scandal
Avandia is back in the headlines. This time, it’s because a supposedly independent doctor leaked confidential information to Big Pharma giant GlaxoSmithKline (which makes Avandia).
This researcher (Dr. Steven Haffner) was reviewing a study that made Avandia look really bad… before it got published in the New England Journal of Medicine (NEJM). Instead of just doing what he was supposed to, and making sure the study was credible, he ran to his ol’ buddies at GSK with the damaging information more than two weeks before the study was due to be published. That explains how the company was able to respond so quickly to the reports that their drug increased heart attack risk by 43%.
What I’d really like to know, though, is why the NEJM asked a researcher who’d worked as a paid consultant (to the tune of $75,000) for GSK to review a study that basically slammed the company. That’s just asking for a leak…or maybe setting one up. Which really leaves us a little short on mainstream medical icons we can trust.U.S SENATORS ALLEGE FDA COMPLICITY OVER AVANDIA SCANDAL.
Posted by drgooch on July 26, 2007
Purdue Pharmaceutical to pay $600 million
Posted by drgooch on October 1, 2007
The makers of the popular (many people say too popular) painkiller Oxycontin have pleaded guilty to misleading regulartors, doctors and patients about how genuinely destructive their product can be. Purdue Pharmaceutical originally patented the drug back in 1996 and it was privy to one of the biggest marketing campaigns in the history of the painkilling industry. The reason why they’ve had to admit liability and pay a $600 million dollar settlement is that the fact that they originally marketed Oxycontin as a safe alternative to Vicodin and Percocet, that was substantially less prone to be addictive.
Are you kidding me? Within four years the stuff had literally taken over rural America as the drug of choice for both experienced dope-heads and high school kids alike. The chemical compound for Oxycontin is the exact same as heroin. The only difference is that Oxycontin is never cut with anything and produces a clean, consistent high every time- something you don’t get with heroin (apparently).
“Misbranding” drugs is a federal crime. And a lengthy amount of prosecutorial disclosure has showed an extreme amount of complicity on the part of Purdue Pharmaceutical executives to deliberately cover up the destructive effects of their heroin tablets.
Granted, many people need Oxycontin after painful surgery or cancer treatments of to control the pain of terminal illness or amputation. But college kids should not be crushing these up and horking them up their noses. But no, Purdue Pharmaceutical wanted to make sure that it found its way into the medicine cabinets of regular pain sufferers. All to make a buck.
The most expensive marketing campaign in the history of painkillers produced a lot of profits and a lot of ruined lives. In the grand scheme of things, $600 million dollars seems a bit light.
Posted in Big Pharma, Healthcare scandal, complicity, oxycontin | Leave a Comment »
Hip Replacement recall
Posted by drgooch on October 1, 2007
A number of hip implants are starting to fall apart according to a recent report from the UK Medicines and Healthcare Products Regulatory Agency. I originally stumbled on this news on a BBC website several weeks ago. Basically the scandal boils down to a company named Smith & Nephew (never trust your nephew) making a bunch of hip replacement parts and then shipping them over to the UK. Following that, they were shipped to hospitals to await use in surgery.
Eventually, somebody back at the office discovered that an “inappropriate mixing of head and cup sizes due to incorrect labelling of the cups” caused the things to basically fall apart. They issued what the Brits call a “medical device alert” and UK health professionals were all advised to send the hips back.
The two big parts of the hip replacements come in various sizes. Unfortunately, due to what was basically a labeling error at the assembly plant, the parts were mis-sized.
Unfortunately, a few hips had already found homes.
According to the BBC story, “Two UK patients have had their hip implants replaced after a labeling error meant they were given the wrong size.” Do these people not have quality control? Hip-replacement surgery is tough enough for a senior citizen to have to deal with, let alone having to get it done more than once FOR THE SAME HIP. Does nobody check these pieces of vital equipment that probably cost several thousand dollars? This type of oversight is completely wrong and can you believe that the company hasn’t even been sued yet? Can somebody get these people a lawyer?
The scariest part about this is that only half of the replacement hips affected by the re-call have been recovered. Who knows where the other ones are?
Posted in Healthcare scandal, complicity, recall | Leave a Comment »
The FDA is obviously lying over Prilosec and Nexium
Posted by drgooch on August 13, 2007
Two recent studies have prompted the FDA to stop dragging their feet and begin investigating whether Prilosec and Nexium cause an increased risk of heart attacks. Personally, whether or not this is true is besides the point- it is now plainly clear that the FDA is working for the companies and not for the American people. What’s mandate for the FDA? Even if they officially rule that there is no heart attack danger posed by Prisolec or Nexium, we should have known about the potential for problems beforehand. If they haven’t completely sorted out whether or not something gives you heart attacks during the testing phase of a new drug, it leaves you wondering what else they’re forgetting to test properly.
Investors seem to be worried about the FDA inquiry as AstroZeneca, the makers of these over-the-counter medications have taken a sharp downward slide in the past few days. The Wall Street Journal from August ninth noticed found the activity enough to write about the direct correlation between AstroZeneca’s drop in share price and the announcement of the FDA investigation.
“The regulators said in pretty clear terms that the review isn’t likely to amount to much, but that wasn’t enough to calm investors made skittish by the FDA’s tougher stance on drug safety. AstraZeneca stock fell more than 5% this morning before starting to recover.”
At the moment, the stock is still down in after-hours trading.
The FDA inquiry was prompted by two separate European studies concluding that Prilosec and its close relative Nexium caused a greater increase in risk of heart attacks, heart failure and heart-related sudden death. Generally, those types of side effects aren’t worth the risk from symptoms derived from eating too much pepperoni pizza.
Canada’s Globe and Mail noted that this isn’t the only time potential problems have been raised in reference to Prilosec, which in Canada is marketed simply as Losec. I’m not sure what particular data told them that Americans are more likely to buy something with “pri” as a prefix, but I guess we’ll leave that up to AstroZeneca and their marketing agency.
While many people have heeded the news releases from AstroZeneca and kept on taking their Nexium and (Pri)losec, something the FDA has also been urging people to continue, the media is now reporting that conclusive evidence will only be available in three months time. Friday’s New York Times stated that “The F.D.A. will need another three months to complete a thorough analysis of the drugs’ safety.”
Hardly sounds conclusive, but then again, we can trust the FDA… right?
Posted in FDA, Healthcare scandal, Nexium, Prilosec, blame canada | Leave a Comment »
U.S SENATORS ALLEGE FDA COMPLICITY OVER AVANDIA SCANDAL.
Posted by drgooch on July 26, 2007
Several days ago, Senate Finance Committee Chairman Max Baucus and Senator Charles Grassley (democrat and republican, respectively) have added fuel to the massive fire brewing over the Avandia diabetes drug scandal. The Senators sent a letter to the FDA, the government agency responsible for approving new drugs, that alleged complicity on the part of the FDA to sweep possible side-effects under the rug in order to assure approval for Avandia’s maker, industry stalwart GlaxoSmithKline.
The Diabetes blog has been following this controversy closely over the past few months. They revealed some details of the contents of the allegation made by the senators. Allegedly, “a former FDA primary reviewer for Avandia was removed from her/his work on the drug after voicing safety concerns,” the article also noted that, “The unnamed scientist believed the evidence for risk of congestive heart failure was strong enough for a “black box” warning on Avandia.”
Obviously, GSK thought that a black box warning would inhibit sales of their precious new diabetes drug and they used their insidious tentacles to get inside the FDA and have the offending analyst removed. Literally, the results of the study were not to the liking of a private corporation, so they used their influence to have that person’s expert opinion silenced. Is this part of the FDA’s mandate?
A study from the New England Journal of Medicine confirms that a patient taking Avandia (the fancy corporate name for rosiglitazone) has just increased their risk of heart attack by a full 43%.
An older post from the Diabetes Blog noted some extremely troubling statistics in terms of reported side-effects from Avandia patients. “According to a new Associated Press (AP) feature, federal regulators have experienced a dramatic surge in reports of Avandia-related side effects. In fact, they say they are receiving triple the number of reports just in the last month.”
While an exponential increase in reported side effects is troubling, the post goes on to note some even more depressing news.
The key finding: in the thirty-five days before the Avandia story broke in the media, only five heart attacks were reported as side effects involving rosiglitazone. Rosiglitazone is the active ingredient in Avandia and its little cousin Avandamet, which combines that drug with metformin. Yet in the thirty-five days following the revelation, that number soared to ninety. The AP also says reports of heart-related hospitalizations increased dramatically.
The author of the Diabetes Blog Post is adamant that all of this complicity leads us to one inevitable conclusion- we must dramatically reform the FDA. In its current form, it serves as a conduit for big pharma to get their new products through the government hurdles as easily as possible. The Avandia scandal serves as concrete proof that the FDA now places American corporate health before the health of the public that they are sworn to protect.
At the very least, the scandal has hit GSK in the pocketbook. Simon Margolis, MD wrote a post in the Yahoo Health News Blog that mentioned many doctors are now turning away from Avandia because they don’t want their diabetic patients to wind up as heart patients in the near future. Margolis quotes Dr. David Nathan from the Diabetes Center at Massachusetts General Hospital saying “Physicians may find it difficult to explain to their patients why they are starting treatment with a potentially dangerous drug when other choices with longer and better safety records are available.”
Posted in Avandia, FDA, US Senate, diabetes | Leave a Comment »
CLASS ACTION SUIT LOOMS AFTER CANADIAN CANCER OFFICIAL STEPS DOWN OVER ALLEGATIONS OF GROSS INCOMPETENCE
Posted by drgooch on July 26, 2007
A large segment of the American population is starting to point to Canada’s government-run healthcare a potential model for the new system that America sorely needs. However, despite what Michael Moore might have you think (and we all love Mike), Canada is not immune to healthcare scandals.
George Tilley, chief of the province of Newfoundland’s largest health board, resigned after a massive public outcry over faulty cancer diagnosis. The focal point of this healthcare scandal is based in a series of small communities in an area called Burin Peninsula. An incompetent radiologist had been practicing for more than a decade in this area and a string of faulty cancer diagnoses have resulted in an unprecedented backlash. After an extensive internal investigation, faults were found at the highest level.
The Wall Street Journal Health Blog contains some concrete details on the extent of this series of deadly mistakes. “At least 36 women in eastern Canada died of breast cancer after a common medical test produced the wrong result. And more than 300 women who are still alive also received the wrong result on the test, which measures whether a tumor is sensitive to hormones. The test is important because tumors that are hormone-sensitive can be treated by powerful drugs such as tamoxifen.”
The provincial government had formed an agreement with a company called Eastern Health to provide testing and diagnostic equipment in the Burin Peninsula area. The CEO of Eastern Health only announced his resignation after a massive public outcry erupted over Eastern Health’s public handling of the scandal.
The WSJ Health blog also reported that “news emerged that more than 1,000 of the tests performed between 1997 and 2005 may have been flawed. But it was not until this week that the government of Newfoundland and Labrador fully disclosed the toll taken by the errors, the Globe and Mail reports this morning.”
The Cancer Blog also reports that “George Tilley now faces class-action lawsuits from individuals that apparently received inaccurate breast cancer testing results.”
Posted in Healthcare scandal, Michael Moore, blame canada, complicity | Leave a Comment »
CONFIDENTIAL BLUE-CROSS MEMO ABOUT SICKO IS LEAKEDTO MICHAEL MOORE
Posted by drgooch on July 8, 2007
In an astonishing example of destruction of the system from within, a rogue employee of mega-conglomerate Capital BlueCross leaked a confidential internal memo about Michael Moore’s new film SiCKO directly to Mr. Moore himself. In an open letter to his readers (and seemingly the HMO’s as well) Moore says “The memo, which I am releasing publicly in this email, is a fascinating look at how one health care company views “Sicko” — and what it fears its larger impact will be on the public. The industry’s only hope, the memo seems to indicate, is if the movie flops.”
Capital BlueCross Vice President of Corporate Communications, Barclay Fitzpatrick, wrote a supposedly confidential internal memo to all staff in order to alert them to potential flak they could receive from customers after they saw this film. Moore revealed much of Fitzpatrick’s letter in his latest post.
Moore states, “he then assesses the film’s impact: “[T]he impact on small business decision makers, our members, the community, and our employees could be significant. Ignoring its impact might be a successful strategy only if it flops, but that has not been the history of Moore’s films … If popular, the movie will have a negative impact on our image in this community.”
Moore ends his letter to his fans by openly challenging the CEO of Capital BlueCross to a public debate. Tongue in proverbial cheek, Moore assures the corporations executive staff to not be intimated by him or his film. “But don’t be scared, and certainly don’t be ashamed to be a capitalist. Greed is good! Especially good for you. There’s nothing like having the pre-existing condition of being rich, should you ever get sick and need help.”
Posted in Blue Cross, Healthcare scandal, Michael Moore | Leave a Comment »
CONSERVATIVE AMERICANS WANT PEOPLE TO FEAR A NATIONAL HEALTHCARE SYSTEM
Posted by drgooch on July 7, 2007
It is plain to see that Fox News had hit an all-time low in terms of ridiculousness. With their recent drop in ratings becoming all the more obvious, Fox News must be attempting to get people’s attention by being as ridiculously outlandish as possible. Their latest ploy has been a desperate attempt to piggyback on the success of Michael Moore’s SiCKO movie and equate the idea of a National Healthcare Service with radical Muslim terrorism.
I am not making any of this up. Here, have a look for yourself.
National Review Online Columnist Jerry Bowyer was the guest of honor and he explained his theory that Britain and France have experienced so many terror attacks is because they have socialized healthcare- a proven breeding ground for terrorism!
A post from The Carpetbagger pretty much summed it up when they quoted one of Bowyer’s most ridiculous comments, ““[I]f one of your guys is a jihadist, if one of your doctors is spending all the time online reading Osama bin Laden fatwas, someone’s going to notice that. But the National Health Service is more like the post office, you know there’s a lot of anonymity, it’s easy to hide in the bureaucracy.”
Ahh, of course, international terrorists are known for their love of bureaucracy. The posts author skewered Bowyer and Fox news with the closing comment, “so let this be a lesson to all of us. National health care may offer better care to more people for less money, but that won’t matter because your doctor will be an Al Qaeda mole.”
Thinkprogress’s post quoted Bowyer a bit further and noted his explanation for terrorists apparent infatuation with western-style bureaucracy, “A state run health care enterprise is bureaucratic, and I think the terrorists have shown over and over again, whether it’s dealing with INS or whether it’s dealing with airport security, they’re very good at gaming the system with bureaucracies. They’re very good at getting around bureaucracies.”
Wow.
Now, folks, Fox News is free to talk about whatever it wants as it is guaranteed to them by our countries constitution. However, it’s a fact that this type of commentary does a disservice to everybody by lowering the debate and essentially turning it into farce. How can we debate the merits and detriments of socialized healthcare when the so-called “conservative” standpoint is so blatantly ridiculous?
No comments:
Post a Comment