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Risks? They Didn't Stop These 7 Drugs From Making Money

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Have you ever noticed how warnings about dangerous prescription drug always seem to surface after the drug is no longer marketed and its patent has run out? As in after the fact? Whether it's an FDA advisory or a trial lawyer solicitation about harm that may have been done to you, the warnings are always belated and useless. If a drug people took four years ago may have given them liver damage, why didn't the FDA tell them then? Why didn't the FDA recall the drug or better yet, not approve it in the first place?



As seen on.....TV! by Martha Rosenberg

Of course, the official answer from the FDA and Big Pharma is that problems with a drug are only seen when millions begin using it which is why post-marketing surveillance is conducted. In other words--who knew? But in a startling number of cases revealed in court documents Pharma did   "know" and clearly misled medical journals, the FDA, doctors and patients, hoping to get its "patent's worth" before the true risks of a drug surfaced. In other cases, Pharma and the FDA should have known before rushing a dangerous drug to market and making money at the expense of patients.

It is the business model for new drugs that provokes Big Pharma to bury risks and exaggerate benefits. A new drug under patent has a high price and no competition and will make millions or even billions every year it is under patent. A settlement for death or injuries down the road is a nuisance and just the cost of doing business. Needless to say, the "forgiveness is cheaper than permission" business plan breeds shameless repeat offenders since the company makes money and no officers go to jail.

Hidden and unforeseen risks in new drugs are such a danger that some medical professionals advise patients to wait up to seven years before they try a new drug. Of course, the drug is no less risky when made by a generic drug maker except that it has been in use longer and is not accompanied by slick advertising to push demand and even "sell" the condition it treats.   But generics have their downside too. Unlike branded drug companies, a 2013 Supreme Court ruling says generic drug makers can't be sued.   Here are some drugs whose risks did not did not keep them from getting "patent's worth."

Vioxx

Remember the "super aspirin" Vioxx, that was heavily marketed by Merck and athletes Dorothy Hamill and Bruce Jenner 15 years ago?   Vioxx was a wonder drug that treated everything from arthritis pain to menstrual cramps, said its ads, sparing user the gastrointestinal problems caused by older drugs like aspirin. Of course it turned out that Vioxx was super at something else too : it doubled the risk of cardiac events , causing 27,785 heart attacks and sudden cardiac deaths according to news sources. While Merck pleaded ignorance of this lethal perk, the New England Journal of Medicine in 2006 accused Merck of concealing "critical data on an array of adverse cardiovascular events" caused by Vioxx.   It was withdrawn in 2004. In 2007, Merck agreed to pay $4.85 billion to patients or survivors' families which represented less than one year of Merck's profits, computed the New York Times. Vioxx made Merck an estimated $2.5 billion a year from its 1999 launch to its 2004 withdrawal. Who says crime doesn't pay?

Fosamax

Vioxx was not the only Merck drug that demonstrated that forgiveness is easier and cheaper when it comes to marketing new drugs. Merck's Fosamax, the first of an anti-osteoporosis drug class called biphosphonates that included Boniva and Actonel, was linked to heart problems, intractable pain, jawbone death, bone fractures and esophageal cancer- after its patent ran out in 2008 . Court-released documents reveal that Merck scientists knew about Fosamax' link to jawbone death as early as the 1970s in animal studies! There was even a subplot to Merck's mendacity. The company installed bone density scanners in medical offices across the US to scare women into taking Fosamax if their scans revealed thinning bones, reported National Public Radio. The subterfuge of "selling" the disease of thinning bones to sell Fosamax did not make a big dent into sales when it came to light: Fosamax was already off patent!


Another wonder drug by Martha Rosenberg
 

Lipitor

What drug is the best selling drug in the history of pharmaceuticals ? Making $125 billion in 14 and a half years and as much as $11 billion in a single year? You have to ask? Lipitor, Pfizer's blockbuster statin drug, owed its success to two factors. It was launched in 1997 when direct-to-consumer drug advertising was just beginning and it harnessed the growing national fear of cholesterol-linked heart attacks. Thanks to Lipitor's "Know Your Numbers" TV ads and Pfizer reps who saturated medical offices with free samples of the white pills and sometimes lunch, more than 29 million people were prescribed Lipitor. But in 2012, the same year that Lipitor's patent expired , those 29 million people (and millions taking other statins) got a surprise from the FDA. The agency make a label change that warned that Lipitor and other statins could cause diabetes, liver injury, muscle damage and memory impairment . Who knew? The quartet of concerns "should not scare people off statins," said Amy G. Egan, deputy director for safety in the FDA's Division of Metabolism and Endocrinology Products. Right.

Nexium

What is the second best selling drug, after Lipitor? The Purple Pill . Like statins, Nexium and the other Proton-Pump Inhibitors (PPI) to treat gastroesophageal reflux disease (GERD), became household medications thanks to direct-to-consumer advertising. After the slick drug ads ran on TV, millions believed   they were at risk for GERD (and heart disease, thinning bones, insomnia. Depression".). Before Proton-Pump Inhibitors, people took over-the-counter treatments like Tums or Tagamet when they had heartburn or indigestion. As the afflictions were upgraded into the "disease" of GERD, Nexium made almost $5 billion in the US in one year and the class of PPIs made $13.6 billion in one year, translating into 119 million prescriptions. In 2012, the same year the FDA warned about statins, the FDA warned the public that Nexium and the whole class of PPIs are linked to Clostridium Difficile, a stubborn and sometimes deadly intestinal infection that is becoming increasingly drug resistant and hard to treat. In 2013, medical literature linked PPIs to fractures, calcium and magnesium deficiencies, community-acquired pneumonia and Vitamin B-12 deficiencies. Research by John P. Cooke, clinical professor at Houston Methodist Hospital, found in 2013 that PPIs might cause blood vessels to constrict and cardiovascular risks. Not a great ending for the blockbuster Nexium whose patent runs out in 2014.

Adderall

It is no secret that doctors, parents and teachers are calling millions of children ADHD. Thanks to Pharma marketing, ADHD is now the second most common long-term diagnosis in children after asthma, says the New York Times often conferred for "childhood forgetfulness and poor grades." While some critics of the massive dosing say boys are being penalized for being boys and that "treatment" used to be recess, Pharma spin campaigns maintain that daily stimulants do not hurt kids. (Spin even claimed the parentally-administered speed would protect kids from becoming drug addicts when they grew older until a 2013 j ournal article revealed otherwise.) But in 2009, the same year the Adderall XR, went off patent (and two years before Concerta, a time-release version of Ritalin went off patent) a study in the American Journal of Psychiatry found the drugs were actually killing kids. There was "A significant association of stimulant use with sudden unexplained death emerged from the primary analysis," wrote the authors who looked at 564 cases of sudden death in children 7 to 19.   Pro-stimulant Pharma doctors disputed the study, saying the drugs might spare users death by improve their driving skills. Why didn't anybody test that ?

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Martha Rosenberg is an award-winning investigative public health reporter who covers the food, drug and gun industries. Her first book, Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health, is distributed by Random (more...)
 

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Thanx Martha.  I've known how irresponsible ... by Suzana Megles on Tuesday, Jan 14, 2014 at 9:44:05 AM
You have it right on, Suzan. That is what I mean w... by revzef on Tuesday, Jan 14, 2014 at 7:57:17 PM
Thank you for this important article exposing the... by b. sadie bailey on Tuesday, Jan 14, 2014 at 11:07:29 AM
And let's not forget how complicit our government,... by Sara Cope on Tuesday, Jan 14, 2014 at 11:17:31 AM
Wow, Sadie -good comment.  But a very sad one... by Suzana Megles on Tuesday, Jan 14, 2014 at 11:50:52 AM
So when are we going to get it? The drug companie... by revzef on Tuesday, Jan 14, 2014 at 12:00:29 PM
Another good comment Revzef.  I am beginning ... by Suzana Megles on Tuesday, Jan 14, 2014 at 12:39:01 PM
I too see it that way, Suzana, and at times I thi... by revzef on Tuesday, Jan 14, 2014 at 7:26:50 PM
You amaze me Revzef with your common sense, your ... by Suzana Megles on Wednesday, Jan 15, 2014 at 6:28:50 AM
At this time altruism is repressed. It is sitting... by Paul Easton on Wednesday, Jan 15, 2014 at 2:48:59 AM
The answer is not big lawsuits for harm and death.... by Martha Rosenberg on Tuesday, Jan 14, 2014 at 1:19:52 PM
How about doctors get paid to keep us well? It se... by Ken Wertz on Tuesday, Jan 14, 2014 at 3:12:51 PM
The US government is a for-profit corporation wi... by allen heart on Tuesday, Jan 14, 2014 at 3:18:26 PM
So what about the death toll from birth control pi... by elizabeth stanton on Tuesday, Jan 14, 2014 at 3:59:03 PM
I think that we should resist the mammogram. Thin... by revzef on Tuesday, Jan 14, 2014 at 8:19:27 PM
You're right Revzef that mammograms are an outrag... by elizabeth stanton on Wednesday, Jan 15, 2014 at 2:24:32 PM
The problem is not only big pharma and profiteeri... by Paul Easton on Tuesday, Jan 14, 2014 at 6:36:34 PM
So, so right Paul.  I hope that your have fou... by Suzana Megles on Wednesday, Jan 15, 2014 at 11:04:51 AM
Your article shows how much the FDA is working for... by kappie on Wednesday, Jan 15, 2014 at 8:39:38 AM