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<\/a><\/b><\/h5>\n\u201cToday we know that the risk of heart attack and stroke may occur early in treatment, even in the first weeks\u00a0\u2026\u00a0\u201cThere is no period of use shown to be without risk,\u201d says Judy Racoosin, M.D., M.P.H., deputy director of FDA\u2019s Division of Anesthesia, Analgesia, and Addiction Products.\u201d<\/p>\n
\u2013\u00a0FDA website<\/a><\/p><\/blockquote>\n
July 25, 2015 \u201cInformation Clearing House<\/a>\u201d \u2013 \u201cCounterpunch<\/a>\u201c \u2013 In case you missed it: The FDA has just issued a warning on various prescription and non-prescription drugs that Americans ingest by the boatload. As it happens, these seemingly benign pain relievers can kill you even if you scrupulously follow the recommended dosage. But don\u2019t take my word for it. Here\u2019s a blurb from the FDA website:<\/p>\n
\u201cFDA is strengthening an existing warning in prescription drug labels and over-the-counter (OTC) Drug Facts labels to indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) can increase the chance of a heart attack or stroke, either of which can lead to death. Those serious side effects can occur as early as the first few weeks of using an NSAID, and the risk might rise the longer people take NSAIDs. (FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs<\/a>, FDA website)<\/p><\/blockquote>\n
Notice how the FDA refers to \u201cdeath\u201d as \u201ca serious side effect.\u201d How\u2019s that for an understatement? Here\u2019s more from the FDA warning:<\/p>\n
\u201cThe OTC drugs in this group are used for the temporary relief of pain and fever. The prescription drugs in this group are used to treat several kinds of arthritis and other painful conditions. Because many prescription and OTC medicines contain NSAIDs, consumers should avoid taking multiple remedies with the same active ingredient.\u201d The New York Times includes \u201cMotrin IB, Aleve and Celebrex\u201d in this group of \u201cwidely used painkillers \u201c.<\/p><\/blockquote>\n
Why isn\u2019t this headline news? People take tons of these chemicals everyday thinking they\u2019ve been thoroughly tested and are totally safe. Now we find out that\u2019s not the case. Now we discover that you can get a heart attack or stroke \u201cas early as the first few weeks of using\u201d them. Doesn\u2019t that come as a bit of a shock to you, dear reader? Doesn\u2019t that make you suspect that the FDA is not telling the whole truth here, but is simply covering up for a profit-obsessed industry that doesn\u2019t give a rip about its customers health?<\/p>\n
Take a look at some of these articles I dredged up on Google News on the topic:<\/p>\n
\u201cDoctors issue Ibuprofen toxicity warning.\u201d Daily Telegraph. \u201cWarning: Runners May Be At Risk From Ibuprofen Use.\u201d Australian Marathon Review. \u201cIbuprofen \u2018trebles the risk of a stroke\u2019 doctors warn\u201d, Daily Mail Online. \u201cIbuprofen Side Effects Land Thousands in the Hospital\u201d, Side-Effects. com. \u201cThe FDA\u2019s Dilemma About Ibuprofen And Cardiovascular Risk\u201d, Forbes. \u201cIbuprofen Blunts Aspirin\u2019s Cardioprotection. FDA Issues Warning\u201d, lexi.com. \u201cAspirin, Ibuprofen Warnings Advised\u2013Health: Consumers need to be told the painkillers can cause internal bleeding and kidney damage, a panel tells the FDA.\u201d, LA Times.<\/p><\/blockquote>\n
And how reliable is FDA in determining the toxicity of these medications anyway? Wasn\u2019t the so-called \u201cwatchdog\u201d agency implicated in pay-to-play flap just a couple years ago? Some readers might recall another incident when the FDA was caught in a \u201cspying program on its own scientists, lawmakers, reporters and academics\u201d to \u201cdiscourage whistleblowing.\u201d According to Truthout\u2019s Martha Rosenberg: \u201ctop FDA managers \u201ccommitted the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along.\u201d Review procedures at the agency (which approves stents, breast implants, MRIs, and other devices and machinery) were so faulty that unsafe devices \u2013 including those that emit excessive radiation \u2013 were approved, charged the scientists, provoking an OSC investigation \u2026 For reporting the safety risks, the scientists became targets of the now-disclosed spy program and some lost their jobs. \u201c\u2026<\/p>\n
(According to FDA drug reviewer Ronald Kavanagh) \u201cWhile I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. We were prevented, except in rare instances, from presenting findings at advisory committees. In 2007, formal policies were instituted so that speaking in any way that could reflect poorly on the agency could result in termination. If we asked questions that could delay or prevent a drug\u2019s approval \u2013 which of course was our job as drug reviewers \u2013 management would reprimand us, reassign us, hold secret meetings about us, and worse. Obviously in such an environment, people will self-censor.\u201d (Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety<\/a>, Martha Rosenberg, Truthout)<\/p>\n
Nice, eh? And this is the agency that\u2019s supposed to protect the public from risky drugs?<\/p>\n
Right. Does the name \u201cVioxx\u201d ring a bell? If not, here\u2019s a little refresher from an article by Fred Gardener in Counterpunch titled \u201cMerck Pays a Pittance for Mass Deaths\u201d:<\/p>\n
\u201cMerck has agreed to pay $950 million and has pleaded guilty to a criminal charge over the marketing and sales of the painkiller Vioxx,\u201d the New York Times reported Nov. 23 \u2026<\/p>\n
The FDA had initially approved Vioxx (after a hasty \u201cpriority review\u201d) in May, 1999 to treat osteoarthritis, acute pain, and menstrual cramps. By September 30, 2004, when Merck announced its \u201cvoluntary recall,\u201d some 25 million Americans had been prescribed the widely hyped drug. Evidence that using Vioxx doubled a patient\u2019s risk of suffering a heart attack or stroke \u2014based on a review of 1.4 million patients\u2019 records\u2014 was about to be published in Lancet by David Graham, MD, an FDA investigator. The FDA director\u2019s office, devoted valet of Big PhRMA, had contacted the Lancet in a futile effort to stop publication of their own scientist\u2019s findings.<\/p>\n
Graham\u2019s data indicate that 140,000 Americans suffered Vioxx-induced heart attacks and strokes; 55,000 died, and many more were permanently disabled. The Merck executives\u2019 real crime was conspiracy to commit murder\u00a0\u2026\u00a0An early clinical trial had alerted them to the fact that Vioxx caused coronary damage. Their response was to exclude from future trials anyone with a history of heart trouble!<\/p>\n
Once Vioxx was approved, Merck spent more than $100 million a year advertising it\u00a0\u2026\u00a0Sales hit $2.5 billion in 2003. And when brave Dr. Graham first presented his irrefragable evidence to an FDA advisory committee in February 2004, Merck argued that the \u201cunique benefits\u201d of Vioxx warranted its remaining on the market. The FDA committee voted 17-15 to keep it available with a black box warning. Ten of the 32 committee members had taken money from Merck, Pfizer or Novartis (which were pushing drugs similar to Vioxx) as consultants. If these MDs had declared their conflicts of interest, Vioxx would have been pulled from the market by a vote of 14-8. By buying an extra seven and a half months, Merck made an extra billion or two, and killed 6,000 more Americans.<\/p>\n
Worldwide, Vioxx was used by 80 million people. Assuming their dosages were similar to the 1.4 million Kaiser Permanente patients whose records Dr. Graham analyzed, the death toll exceeds 165,000.\u201d (Merck Pays a Pittance for Mass Deaths<\/a>, Fred Gardner, CounterPunch)<\/p><\/blockquote>\n
Is that what\u2019s going on? Is some prestigious organization like Lancet about to release a damning report on these dubious pain relievers, so the FDA is trying to get ahead of the story to save their own kiester? How much has the culture at the FDA really changed since the Vioxx scandal? Is the agency still owned and operated by the industries its supposed to regulate?<\/p>\n
Do you really need to ask? The better question would be: What regulatory agency in the U.S. ISN\u2019T owned corporate America? They own it all; lock, stock and barrel.<\/p>\n
And, keep in mind, (according to Gardner) Vioxx killed over 165,000 people.<\/p>\n
Now guess how many Merck executives went to jail?<\/p>\n
Yep. Zero.<\/p>\n
I\u2019m not saying these medications don,t help to relieve chronic pain from \u201cdebilitating conditions, including osteoarthritis, rheumatoid arthritis\u200e, gout and other rheumatological and painful conditions\u201d. They do. But whether they\u2019re useful or not doesn\u2019t change the fact that \u201ceven small amounts\u201d of this crap can put you at risk of a heart attack or stroke. That\u2019s what the public needs to know, and that\u2019s the FDA\u2019s job. Here\u2019s an excerpt from an article in the NYT<\/a> that tries to minimize the dangers:<\/p>\n
\u201cThe broader context is important. The relative risk of heart attack and stroke from the drugs is still far smaller than the risk from smoking, having uncontrolled high blood pressure or being obese.\u201d<\/p><\/blockquote>\n
True, and it\u2019s probably less risky that bungee-jumping off the Empire State Building, but what difference does that make. The fact is, it can kill you, the FDA KNOWS it can kill you, and yet they haven,t done anything to counter the relentless tsunami of industry generated propaganda that has convinced the American people that these medications are risk free. Here\u2019s more on that from the Times:<\/p>\n
\u201cThe agency said it would ask drug manufacturers to change the labels to reflect new evidence that the drugs increased the risk of heart attack and stroke soon after patients first started taking them, and that while the risk was higher for people with heart disease, it surfaced even for people who had never had heart problems.\u201d<\/p><\/blockquote>\n
Let me get this straight: The FDA knows that these anti inflammatories are killing people and they\u2019re going to \u201cask\u201d the drug companies if they\u2019ll change the labels? Is this how regulation works in the US nowadays; the agencies basically have to grovel before these cutthroat industries just to get them to do the right thing?<\/p>\n
I have a better idea: Why not just prosecute a few of these drug-pushing executives for manslaughter?
\nThat ought to do the trick, don\u2019t you think?<\/p>\n