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Six Drugs Whose Dangerous Risks Were Buried So Big Pharma Could Make Money


Health & Wellness  (tags: abuse, americans, cancer, children, death, disease, drugs, ethics, family, food, government, healthcare, illness, medicine, protection, research, risks, safety, society, treatment )

Kit
- 337 days ago - truth-out.org
New meds are rushed to the market so industry can start making money even before safety has been determined.



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Kit B. (276)
Wednesday January 22, 2014, 8:22 am
Photo Credit: Shutterstock


When a prescription drug causes risky side effects, the word often doesn’t get out for years, allowing Big Pharma to make money anyway.

The FDA and Big Pharma contend that dangerous side-effects in a prescription drug only emerge when it is used by millions instead of the relatively small group of people in clinical trials. But there is another reason the public ends up guinea pigs. Prescription drugs are rushed to market in as little as six months so industry can start making money while safety is still being determined. Both Merck's risk-laden bone drug Fosamax and painkiller Vioxx were on the market after a six-month review. In the case of Vioxx, it was because "the drug potentially provided a significant therapeutic advantage over existing approved drugs," the FDA said.

Thanks for that. And five drugs (Trovan, Rezulin, Posicor, Duract and Meridia) rushed through in 1997 because of Pharma and congressional pressure on the FDA, says Public Citizen, were subsequently withdrawn.

Here are some drugs whose risks did not did not keep them from getting their "patent's worth."

1. Singulair

You'd think Merck would have learned from Vioxxand Fosamax that aggressive marketing can only hide emerging risks for so long. It didn't. To sell its asthma and allergy drug Singulair to children, the drug giant partnered with Olympic gold-medalist swimmer Peter Vanderkaay and Scholastic and the American Academy of Pediatrics even as the FDA warned about "neuropsychiatric events" including agitation, aggression, nightmares, depression, insomnia and suicidal thinking.

While Merck marketed Singulair, which comes in a cherry-flavored chewable formulation, to parents with slogans like "Singulair is made with kids in mind," Fox TV and over 200 parents on the website askapatient reported that children on Singulair exhibited altered moods, depression and ADHD, hyperkinesis and suicidal symptoms. Fifteen-year-old Cody Miller of Queensbury, NY reportedly took his own life days after taking the drug in 2008. Still, Singulair made $5 billion for the company in 2010. After its patent expired in 2012, Australia's Therapeutic Goods Administration, the FDA’s counterpart, reported 58 cases of adverse psychiatric events in children and teenagers, primarily suicidal thinking. Who knew?

2. Zyprexa

How do you sell a drug that causes 30 percent of users to gain 22 pounds and some to gain as much as 100 pounds? By burying the risks. The antipsychotic Zyprexa was supposed to be Eli Lilly’s followup to its blockbuster antidepressant Prozac even though Lilly knew as early as 1995, according to the New York Times, that Zyprexa was linked to unmanageable weight gain or diabetes. Zyprexa’s side effects of "weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule,” wrote Lilly’s Alan Breier, who later became chief medical officer, in documents obtained by the Times.

Even as Lilly settled charges that it withheld the drug's link to high blood sugar levels and diabetes and illegally marketed the drug for dementia, Zyprexa made $5 billion in 2010 and out-earned Prozac. Who says crime doesn’t pay? Zyprexa was especially marketed to the poor and became one of the nation's top Medicaid drugs extracting at least $1.3 billion of our tax dollars in 2005 alone. In 2008, Lilly settled an Alaskan suit to cover the cost of Medicaid patients who developed diabetes on Zyprexa. Unbelievably, Lilly offered a "free service" to "help" states buy mental illness drugs like Zyprexa as a fox guards the henhouse and 20 states took the bait. Zyprexa's patent ran out in 2012.

3. Seroquel

Like Zyprexa, the antipsychotic Seroquel, made by the UK firm AstraZeneca, became a best-selling medication in the US, earning over $5 billion in 2010, despite frequently reported risks. It was so heavily marketed to poor children that in 2007, Florida's Department of Juvenile Justice's bought twice as much Seroquel as Advil. Seroquel's high use in the military for the unapproved uses of sleep and PTSD was also disturbing: reports of veterans’ sudden deaths on the drug, thought to be cardiac-related, surfaced even as use of Seroquel soared 700 percent in the Department of Defense. In 2009, it was the number-two drug at the VA, accounting for $125.4 million in tax dollars.

Months after Seroquel's 1997 approval, an article in the South Dakota Journal of Medicine raised questions about the drug's unsafe interaction with 11 other drugs. Within three years, researchers at the Cleveland Clinic were questioning Seroquel's effect on the heart's electrical activity. But even as the families of deceased veterans testified at FDA hearings in 2009 and demanded answers from officials and lawmakers, the FDA maintained Seroquel's safety. Then in 2011, with little fanfare, the FDA issued new warnings that corroborated the swirling suspicions: both Seroquel and its extended release version “should be avoided” in combination with at least 12 other medicines, said the FDA. The drug should also be avoided in the elderly and people with heart disease because of clear cardiac risks. Oops. Seroquel's patent ran out the following year.

4. Levaquin

Fluoroquinolone antibiotics are among the biggest-selling drug classes. Many people remember the fluoroquinolone Cipro (given for 9/11-era anthrax attacks) but Pharma hopes we don’t remember the fluoroquinolones Trovan, which was withdrawn for causing liver damage, and Raxar, which was withdrawn for causing cardiac events and sudden death. Johnson & Johnson’s fluoroquinolone Levaquin was the US’ best-selling antibiotic in 2010 with sales over a $1 billion a year but is now the subject of thousands of lawsuits.

In 2012, a year after Levaquin’s patent expired, a cascade of side effects began to emerge with Levaquin and the whole class of fluoroquinolones that casts doubt about their safety. The Journal of the American Medical Association reported that of 4,384 patients diagnosed with retinal detachment, 445 (10 percent) were exposed to a fluoroquinolone in the year before diagnosis. The New England Journal of Medicine reported the same year that Levaquin was linked to an increased risk of cardiovascular death, especially sudden death from heart rhythm disturbances.

While the FDA warned of tendon ruptures on fluoroquinolones, especially Achilles’ tendons in 2008, and added a black box warning on the label, it had a serious new warning two years after Levaquin went off patent. In 2013, the FDA warned about the “the serious side effect of peripheral neuropathy” in fluoroquinolones, a type of nerve damage in which sensory pathways are impaired. Peripheral neuropathy caused by fluoroquinolones like Levaquin can “occur soon after these drugs are taken and may be permanent,” warned the FDA. Fluoroquinolones are also linked to Clostridium difficile, also called C. Diff, a serious and potentially deadly intestinal microbe.

5. Topamax

Before its patent expired in 2009, the seizure drug Topamax made Johnson & Johnson a billion a year and it still made $538 million a year after its patent expiration. Topamax was such a favorite for pain conditions in the military it was given the nickname "Stupamax" for the way it slowed reaction times and impaired motor skills, attention and memory, according to Army Times. Not too great for combat.

A year before Topamax went off patent, the FDA warned that it and other seizure drugs are correlated with suicide and asked their manufacturers to add label warnings. Four patients on the drugs killed themselves versus none on placebo reported the FDA after reviewing clinical trials. Then, in 2011, the FDA announced that Topamax can cause the birth defects cleft lip and cleft palate in babies of mothers who take the drug. "Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their healthcare professional," the FDA warned, though the risks did not stop the FDA from approving a new diet drug containing Topamax' generic drug in 2012.

6. Oxycontin

Purdue Pharma's Oxycontin is the granddaddy of drugs that make money despite lethal side-effects. Along with other prescription opioids, it accounted for an astounding 17,000 deaths last year—four times that in 2003. "The increase [in use] has been fueled in part by doctors and pain advocacy organizations that receive money from drug companies and make misleading claims about the safety and effectiveness of opioids, including that addiction is rare," reported the Journal Sentinel.The American Geriatrics Society used Pharma-linked experts to rewrite clinical guidelines in 2009, says the Journal Sentinel, which specified opioids for all patients with moderate to severe pain as opposed to Aleve or Advil. Ka-ching.

Oxycontin, because it is a long-acting formulation, was supposed to reduce toxicities and addictiveness—at least until its crush, snort and shoot potential made it more popular than cocaine on the street. (All the pill's 80mg could be taken at once.) In 2010, responding to the addictions, overdoses, deaths and diversions associated with the drug, Purdue rolled out a tamper-resistant Oxycontin and began to push for state and federal laws requiring opioids to be tamper-resistant in 2012. Purdue said public health was its main concern but many are asking why that concern only surfaced as Oxycontin's patent was expiring. Its patent expired in 2013.
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By Martha Rosenberg | AlterNet | Report | Truth Out |
 

Marianne R. (110)
Wednesday January 22, 2014, 8:33 am
So scary for those people who need new medications which may be their last hope.
 

Arielle S. (317)
Wednesday January 22, 2014, 8:46 am
But how else could they afford to pay for their big, well-equipped facilities and their CEO bonuses and their stock profits? We're all gonna die sooner or later anyway, why should they care when? (and I am being sarcastic)
 

Pat B. (355)
Wednesday January 22, 2014, 10:42 am
Unbelievable...but does not surprise me in the least. I'm deeply saddened when people who need meds, can't get it,run a life risk/or die, or it costs a fortune to get it, so that Pharma can, (and will), get benefits and more money. So very, very, cruel of them. Thanks, Kit for this. (Passing this on as well).
 

Roseann d. (178)
Wednesday January 22, 2014, 10:57 am
Yeah, first come the feel-good commercials with dangerous caveats like the side effect of "death". Death isn't a side effect, but the commercials are like a dark Saturday Night Live skit. Then followed by the lawsuit commercials a few months later. Unless I know the ingredients, and how they are sourced, including GMO-free labeling, I am not taking the drug.
 

Kit B. (276)
Wednesday January 22, 2014, 11:29 am

So many things can be prevented by drinking just a little apple cider vinegar each day with even a few tablespoons of (real) extra virgin Olive Oil. I add some garlic to the olive oil. Some friends have finally tried this and within months are not in need of those statins for cholesterol or triglycerides. How many people really NEED an anti-psychotic medication? Few, but more than half of the US is taking them. We are over dosed, over medicated and overly susceptible to advertising.
 

Michael A. (29)
Wednesday January 22, 2014, 11:51 am
noted
 

A F. (132)
Wednesday January 22, 2014, 11:55 am
Evil. Thanks for sharing, Kit
 

Birgit W. (152)
Wednesday January 22, 2014, 1:58 pm
What else is new. Big Corporations only care about their money, and not about us.
 

Terry King (109)
Wednesday January 22, 2014, 2:10 pm
Thankfully, I've never taken any of these medications.
 

ewoud k. (73)
Wednesday January 22, 2014, 2:11 pm
Guess who paid for the burial....

Nobody's interested in how you make your bucks, just make them!

Thanks Kit!
 

Deb E. (63)
Wednesday January 22, 2014, 2:33 pm
I am one of the ones who have had bad reactions to fluoroquinolones and to Singulair. So many people don't know that both FDA and USDA leave the safety studies to the researchers of the "free market" who are the one who stand to gain from sales. Makes no sense, but we aren't very protected when we don't actually regulate corporations based on independent studies. Thanks for this article, Kit
 

Lois Jordan (58)
Wednesday January 22, 2014, 2:40 pm
Noted. Thanks, Kit. And, thanks for the additional info on the apple cider vinegar. We used to take it years ago, but have since forgotten about it.
 

Lois Jordan (58)
Wednesday January 22, 2014, 2:42 pm
Sorry---accidentally hit "submit" before I finished. Meant to say that I'm going to get some more.
 

Past Member (0)
Wednesday January 22, 2014, 2:51 pm
People should read the inserts that come with medications .... they almost always can scare the bejeebers out of people. Everyone has a choice to take or not take medications. I always read the inserts and weigh the info against what I am physically dealing with, my age, my condition and prognosis .... THEN I decide if I'm going to take it. And cider sounds great ... my mother used to drink it ... maybe I should try it.
 

Theodore Shayne (56)
Wednesday January 22, 2014, 4:02 pm
Noted. I never use drugs legal or otherwise.
 

. (0)
Wednesday January 22, 2014, 4:58 pm
Very scary! Thanks for sharing, Kit.
 

JL A. (276)
Wednesday January 22, 2014, 5:04 pm
As ghastly as all of these stories on each drug is, I am thankful it only took as long as it did--due to revised data reporting of adverse events with drugs making it real easy for doctors to report quickly and on-line updated information quickly available on the FDA's website, including the instant a new warning is added.

Also, some of the problem is that children and the elderly react differently to drugs and separate trials have not been required. In some areas, there is also a gender difference in efficacy that are often ignored.
 

Barbara K. (75)
Wednesday January 22, 2014, 6:33 pm
Yes, this country is definitely over medicated. A lot of drugs are not safe. Cipro should be on that list. It causes a lot of harm to the body, and the harm is permanent. You can check it out on WebMD.com. I took it and ended up with the ligaments popping and ended up needing surgery on one shoulder, and all the doctor could say was to be real careful so that I don't have any more damage from it. They tried me on Vioxx when it first came out a long time ago, and my body rejected it immediately. So glad it did. They need to find real cures for many diseases and stop concentrating on keeping us drugged just to make more money off selling medications, most of which are harmful. I listen to the lists of side effects in the ads on TV and wonder why anyone would take such a pill. Thanks for this info, my friend.
 

Katie James (0)
Wednesday January 22, 2014, 6:33 pm
We trust these companies to give us safe meds and we put even more trust into the doctors who prescribe these meds and it sickens me that money is more important then our safety! Hipocratic oath I believe says "do no harm...." doctors and chemists knowingly put these meds out for use and violate our trust and they should be all held accountable! I have battled with pain since a back injury in 1996 and the doctors tried pushing these drugs mentioned in the article at least some of the meds, and they caused more harm then good to my body and shame on them for not giving me proper care and shame on them for these harmful meds!
 

Heidi Aubrey (5)
Wednesday January 22, 2014, 7:48 pm
Have you ever heard the laundry list of side effects that always accompanies the advertisement of ANY prescription drugs?

I mean, the side effects are worse than the condition they are supposed to treat. I try hard to avoid them at all.
 

Suzanne L. (140)
Wednesday January 22, 2014, 10:18 pm
Every evening when my hubby and I listen to the news there is a flood of commercials for drugs - for rheumatoid arthritis, fibromyalgia, asthma, COPD, high blood pressure or cholesterol. And while they show images of happy (and often quite healthy looking) people enjoying life, slowly they start with the narrative about the possible side effects. And they are not little side effects, like dry skin or brittle fingernails. They talk about increased risk for cancers, tb, other serious infections, heart attacks, kidney failure, suicidal ideation, and DEATH.. I think it's best to wait until millions have already tried something to see what's what.
 

Rose NoFWDSPLZ (283)
Thursday January 23, 2014, 12:00 am
Why doesn't this surprise me
 

Robert O. (12)
Thursday January 23, 2014, 12:37 am
Honesty and the truth (which corporations find very inconvenient) go right out the window when big profits are involved. Thanks Kit.
 

Donna Hamilton (152)
Thursday January 23, 2014, 7:01 am
Noted. Appalling, but sadly not surprising - profit is always seen as more important than life. Thanks, Kit.
 

Carmen S. (618)
Thursday January 23, 2014, 8:55 am
Thanks Kit, not surprising at all that this still happens, sad and scary too.
 

Jessica Grieshaber (7)
Thursday January 23, 2014, 10:42 am
This is pretty scary. Thanks for posting
 

Shanti S. (0)
Thursday January 23, 2014, 12:09 pm
Thank you.
 

anne s. (23)
Thursday January 23, 2014, 2:39 pm
Big Pharmacie do this a lot so this isnt anything new
 

Dandelion G. (384)
Thursday January 23, 2014, 6:15 pm
I recall when there were fewer drugs but the ones we had were for antibiotics and a vaccine for polio, that the inventor didn't even take a dime from the polio vaccine. If the CEO's of these manufactured drugs went to jail for their harm they'd stop pushing out this crap.

It is hard to sue, because that is why the do has a list of side effects a mile long, they say, you took it at your own risk, thereby it absolves them from any wrong doing. I'm sorry, if death, suicide, and stroke is a possibility to fix the restless legs, I'll keep the leg situation.

I always go to natural cures first.......so much safer and more gentle on the system.
 

Sherri G. (117)
Friday January 24, 2014, 12:26 am
Gilead has a new drug out Sivaldi for treating Hep C with as much as 80% success rate on HCV types 2 and 3. My doctor is looking into it for me because I have Hep C for 35 years from a blood transfusion. Anyone out there with Hep C may want to look into this. We will see if it really works it could mean a life saving cure. FDA approved it in December. But everyone has to do their homework and weigh the risks against possible benefits. My Mother and Son took Levaquin and I took it once. Thank You Kit for this report. Noted
 

Craig Pittman (47)
Friday January 24, 2014, 5:45 am
Profits rule apparently so we need to do our own research on-line before taking a new drug or any drug for that matter. No one else, it seems, is looking out for us. We sould also advocate for new regulations and hefty penalties for insufficient pre-sale testing.
 

Gloria picchetti (300)
Friday January 24, 2014, 5:46 am
"And the ones that mother gives you don't do anything at all." Jefferson Airplane.
 
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