FDA scandal re: Approval of Deadly Drug by Board with Pharma Ties

Board members with drug maker ties voted to approve drug that's killing women

Thursday, March 15, 2012 by: Tony Isaacs


(NaturalNews) An investigation by the Washington Monthly and the British Medical Journal has found that at least four members of an advisory board which voted to approve a drug used in birth control pills had either done work for the drugs' manufacturer or received research funds from the manufacturer. Though the four committee members disclosed their ties to the FDA, the FDA decided that the ties did not matter and did not make the disclosures public. Tragically, the drugs the committee endorsed have been killing the women who take them.

The birth control pills Yaz and Yasmin contain a drug called drospirenone, which the FDA advisory committee endorsed last December. According to the Alliance for National Health (ANH), women who take drospirenone are nearly seven times more likely to develop thromboembolism (obstruction of a blood vessel by a blood clot, which can cause deep vein thrombosis, pulmonary embolism, stroke, heart attack, and death) than women who do not take any contraceptive pill. Women who take drospirenone have twice the risk of developing thromboembolism than women who take widely prescribed contraceptive pills containing levonorgestrel.

FDA OK's votes by members with financial ties to drug makers but not members who oppose dangerous drugs

Each of the four advisory board members with ties to the pills manufacturer voted in favor of the pills. The committee's decision that the drug's benefits outweighed the risks was decided by a four-vote margin. Interestingly, while the FDA allowed the four members with financial ties to vote on the drug, it barred another member and former researcher, Sidney M. Wolfe, from voting on the grounds that he had "an intellectual conflict of interest". Based on several years of data, Wolfe had advised his readers six years earlier not to take Yaz. Because of this "conflict", he was barred from voting.

In other words, the FDA apparently believes that there is no conflict when someone gets paid by a drug manufacturer but there is a conflict when someone has researched a drug and found it to be dangerous.

The FDA also failed to provide the panel with recently unsealed court documents which revealed that former FDA commissioner David Kessler had accused Bayer of hiding data on blood clot risks associated with the birth control pills. The court documents also revealed that Kessler reported that Bayer paid $450,000 to a high profile gynecologist to sponsor the pill, including off-label use of the drug, during her book tour.

It is far from the first time that the FDA has approved a dangerous drug or overlooked conflicts of interest. It is also far from the first time that drug companies have hid evidence of harm. Think of Vioxx, Fosamaxx, Avandia, and Gardasil to name just a few examples.

It is a common practice for drug companies to pay doctors and scientists to endorse their drugs, the same as it is common for drug companies to offer kickbacks and rewards to doctors who prescribe their drugs. Drug companies also pay doctors, researchers, and other medical experts for "consulting jobs" and speaking engagements to the tune of several hundreds of millions of dollars - which is considered legal despite the obvious blatant conflict of interest.

With Yaz being the top-selling birth control pill in the US, Bayer has quite the strong vested interest in getting endorsements for Yaz and Yasmin. Though thousands of women have filed lawsuits against Bayer, saying they were injured by Yaz or Yasmin, as we have seen with other highly profitable dangerous drugs, drug makers typically consider such lawsuits merely part of the price of doing business.

Sources included:

http://www.anh-usa.org/fda-huge-conflicts-of-interest-with-big-pharma/
http://www.washingtonmonthly.com
http://www.naturalnews.com/034443_FDA_advisory_panel_corruption.html
http://www.allgov.com

The Year in Pills

2010's Hall of Shame
By MARTHA ROSENBERG

2010 will go down as the year the diet pill Meridia and pain pill Darvon were withdrawn from the market and the heart-attack associated diabetes drug Avandia was severely restricted.

But it was also the year the Justice Department filed the first criminal, not civil, charges against a drug company executive. Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline, hid some 1,000 instances of GSK-paid doctors illegally promoting Wellbutrin to other doctors, say authorities.

It was also the year prominent psychiatrists Charles Nemeroff and Alan Schatzberg were accused of writing an entire book for GSK called Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care.

Here are the drugs which make 2010's Hall of Shame.

Yaz and Yasmin

Soon after Bayer launched the pill Yaz in 2006, billing it as going "beyond birth control," 18-year-olds were coming down with blood clots, gall bladder disease, heart attacks and even strokes. FDA ordered Bayer to run correction ads that detail the drugs' risks though Yaz sales are still brisk. In fact, financial analysts attribute a third quarter slump to a Yaz generic coming online, not dangerous side effects.

Lyrica, Topamax and Lamictal

In August FDA ordered a warning on the seizure drug Lamictal for aseptic meningitis (brain inflammation) but it is still the darling of military and civilian doctors for unapproved pain and migraine uses. All three drugs increase the risk of suicidal thoughts and behaviors according to their mandated labels, in addition to the memory and hair loss patients report.

Humira, Prolia and TNF Blockers

The drug industry's highly promoted biologic drugs are made from genetically engineered hamster cells and suppress the immune system, inviting tuberculosis and several cancers. Yet Humira is advertised to healthy people for "clearer skin" and Prolia is advertised to prevent osteoporosis in healthy women.

Chantix

After 397 FDA cases of possible psychosis, 227 domestic reports of suicidal behaviors and 28 actual suicides, the government banned pilots, air-traffic controllers and interstate truck and bus drivers from taking the antismoking drug Chantix in 2008. Its neuropsychiatric effects were immortalized when New Bohemians musician Carter Albrecht was shot to death in 2007 in Texas by a neighbor after acting aggressively on the Chantix.

Ambien

The sleeping pill Ambien was immortalized as the drug Tiger Woods reportedly cavorted with his consorts on and former US Rep. Patrick Kennedy crashed his Ford Mustang on, while driving to Capitol Hill in the middle of the night to "vote" in 2006. Law enforcement officials say it has increased traffic accidents from people who drive in a black out and don't even recognize arresting officers.

Tamoxifen

Is it a coincidence that Tamoxifen maker AstraZeneca founded Breast Cancer Awareness Month and makes carcinogenic agrochemicals that cause breast cancer? As a breast cancer prevention drug, an American Journal of Medicine study found the average life expectancy increase from Tamoxifen was nine day . Public Citizen says for every case of breast cancer prevented on Tamoxifen there is a life-threatening case of blood clots, stroke or endometrial cancer.

Lipitor and Crestor

Why is Lipitor the best selling drug in the world? Because every adult with high LDL or fear of high LDL is on it. And also 2.8 million children, says Consumer Reports. All statins can cause muscle breakdown called rhabdomyolysis. And Crestor is so linked to the side effect, Public Citizen calls it a Do Not Use and the FDA's David Graham named it one of the five most dangerous drugs before at a Congressional hearing.

Boniva

Boniva and other bisphosphonate bone drugs are a good example of FDA approving once unapprovable drugs by transferring risk onto the public's shoulders. The list of dangers on the label includes waiting 60 minutes before eating or drinking anything except plain water, never taking the drug with mineral water, sparkling water, coffee, tea, milk, juice or other oral medicine, including calcium, antacids, or vitamins and not lying down after you take it.
Prempro

Pfizer's hormone drug Prempro is linked to a 26 percent increase in breast cancer, 41 percent increase in strokes, 29 percent increase in heart attacks, 22 percent increase in cardiovascular disease and double the rate of blood clots. But its cognitive and cardiovascular "benefits" are being tested right now at major universities to debut an HT "Light," hoping the public has a short memory.

Prozac, Paxil, Zoloft, SSRIs

Selective serotonin reuptake inhibitor (SSRIs) antidepressants like Prozac, Paxil, Zoloft and Lexapro probably did more to inflate drug industry profits than Viagra. But many say the drugs have also inflated police blotters. In addition to 4,200 published reports of SSRI-related violence, including the Columbine, Red Lake and NIU shootings, SSRIs can cause serotonin syndrome and gastrointestinal bleeding when taken with certain drugs. Paxil is linked to birth defects.

Effexor, Cymbalta, Pristiq, SNRIs

Selective norepinephrine reuptake inhibitors (SNRIs) are like their SSRIs chemical cousins except their norepinephrine effects can modulate pain, which has ushered in your-depression-is-really-pain, your-pain-is-really-depression and other crossover marketing. SNRI's are also harder to quit than SSRIs. 739,000 web sites address "Effexor" and "withdrawal."
Seroquel, Zyprexa, Geodon, atypical antipsychotics

The antipsychotic Seroquel tops 71 drugs on the FDA's January 2010 adverse event report and is linked to unexplained troop deaths and many research scandals. But it's the fifth biggest-selling drug in the world. Atypical antipsychotics cause weight gain and diabetes, the tardive dyskinesia they are marketed to prevent and death in the demented elderly. Yet FDA approved Zyprexa and Seroquel for children last year and the new atypical antipsychotic, Latuda this year. Maybe the FDA is bipolar.

Ritalin, Concerta, Strattera, Adderall and ADHD Drugs

ADHD drugs rob "kids of their right to be kids, their right to grow, their right to experience their full range of emotions, and their right to experience the world in its full hue of colors," says Anatomy of an Epidemic author Robert Whitaker. But they are a gold mine for the drug industry. During an August conference call with financial analysts, Shire specialty pharmaceuticals president Mike Cola lauded the "very dynamic ADHD market," and the "co-administration market" (in which kids don't need one drug but several.

Gardasil and Cervarix Vaccines

A pharma-government plot to inoculate the public with dangerous vaccines? Maybe not but why are governors like Texas' Rick Perry mandating vaccination of girls for HPV? And why was University of Queensland lecturer Andrew Gunn silenced when he questioned the Gardasil vaccine? The HPV vaccine doesn't work for all viral strains, requires a boo$ter and is linked to 56 US girls' deaths as of September, according to the CDC.

Foradil Aerolizer, Serevent Diskus, Advair and Symbicort

Unlike drugs that look safe in trials and develop "safety signals" postmarketing, the long-acting beta agonists (LABA), salmeterol and formoterol, found in many asthma drugs, never looked safe. Studies link them to an increase in asthma deaths, especially in African-Americans and children. They may have contributed to 5,000 deaths said Dr. David Graham at FDA hearings about the controversial asthma drugs.

Singulair and Accolate, leukotriene receptor antagonists

Leukotriene receptor antagonists also never looked safe. Original FDA reviewers said asthma control "deteriorates" on Singulair and it may not be safe in children. Last month, Fox TV reported Singulair, Merck's top selling drug, is suspected of producing aggression, hostility, irritability, anxiety, hallucinations and night-terrors in kids, symptoms that are being diagnosed as ADHD. It is huckstered to parents by the trusted educational service Scholastic, Inc. and the American Academy of Pediatrics.

Dangerous Drugs Big Pharma Shoves Down Our Throats

In the pharmaceutical industry’s rush to get drugs to market, safety usually comes last. And the public suffers. 

By Martha Rosenberg, AlterNet
November 19, 2010

In the pharmaceutical industry’s rush to get drugs to market, safety usually comes last. Long studies to truly assess a drug's risks just delay profits after all -- and if problems do emerge after medication hits the market, settlements are usually less than profits. Remember, Vioxx still made money.

The following drugs are so plagued with safety problems, it is a wonder they’re on the market at all. It's a testament to Big Pharma's greed and our poor regulatory processes that they are.

-- Lipitor and Crestor
Why is Lipitor the bestselling drug in the world? Because every adult with high LDL or fear of high LDL is on it. (And also 2.8 million children, says Consumer Reports.) No one is going to say statins don't prevent heart attack in high-risk patients (though diet and exercise have worked in high-risk groups too). But doctors will say statins are so over-prescribed that more patients get their side effects -- weakness, dizziness, pain and arthritis -- than heart attack prevention. Worse, they think it's old age!

"My older patients literally do without food so that they can buy these medicines that make them sicker, feel bad, and do nothing to improve life," says an ophthalmologist web poster from Tennessee. "There is no scientific basis for treating older folks with $300+/month meds that have serious side-effects and largely unknown multiple drug interactions." What kinds of side effects? All statins can cause muscle breakdown (called rhabdomyolysis) but combining them with antibiotics, protease inhibitors drugs and anti-fungals increases your risks. In fact, Crestor is so highly linked to rhabdomyolysis it is double dissed: Public Citizen calls it a Do Not Use and the FDA's David Graham named it one of the five most dangerous drugs before Congress.


-- Yaz and Yasmin

It sounded too good to be true and it was. Birth control pills that also cleared up acne, treated severe PMS (Premenstrual Dysphoric Disorder or PMDD) and avoided the water retention of traditional birth control pills.

But soon after Bayer launched Yaz in 2006 as going "beyond birth control," 18-year-olds were coming down with blood clots, gall bladder disease, heart attacks and even strokes. Fifteen-year-old Katie Ketner had her gallbladder removed. Susan Gallenos had a stroke and part of her skull removed. College student Michelle Pfleger, 18, collapsed and died of a pulmonary thromboemboli from taking Yaz, says her mother Joan Cummins.

While TV ads for Yaz in 2008 were so misleading that FDA ordered Bayer to run correction ads, Yaz sales are still brisk. In fact, financial analysts attribute the third quarter slump in the Yaz "franchise" of 28.1 percent to the appearance of a Yaz generic, not to the thousands of women who have been harmed.

Why is Yaz sometimes deadly? It includes a drug that was never before marketed in the U.S. -- drospirenone -- and apparently causes elevated potassium, heart problems, and a change in acid balance of the blood. Who knew? But not only is Bayer still marketing it, women do not receive "test subject" compensation for using it either.

-- Lyrica, Topomax and Lamictal

Why would Americans take an epilepsy seizure drug for pain? The same reason they'll take an antipsychotic for the blues and an antidepressant for knee pain: good consumer marketing. In August FDA ordered a warning for aseptic meningitis, or brain inflammation, on Lamictal -- but it is still the darling of military and civilian doctors for unapproved pain and migraine. Lamictal also has the distinction of looting $51 million from Medicaid last year despite a generic existing.

All seizure drugs increase the risk of suicidal thoughts and behaviors according to their mandated labels. An April article in JAMA found seizure drugs linked to 26 suicides, 801 attempted suicides, and 41 violent deaths in just five years.

All three drugs can make you lose your memory and your hair, say posters on the drug rating site askapatient.com. Topamax is referred to as "Stupamax" in the military -- though evidently not enough to ask, "Why am I taking this drug again?"

-- Humira, Prolia and TNF Blockers

If you think pharma is producing a lot of expensive, dangerous injectables lately, you're right. Yesterday's blockbuster pills have been supplanted with vaccines and biologics that are more lucrative and safer...from generic competition, that is. The problem is, not only are biologics like Humira and Prolia creepy and dangerous -- they're made from genetically engineered hamster cells and suppress the actual immune system -- the diseases they treat are "sold" to healthy people.

Recently, thousands of college students in Chicago found inserts in their campus newspapers hawking Humira for Crohn's disease, rheumatoid arthritis and psoriatic arthritis. ("Hate psoriasis? Love clearer skin," says an ad on the Humira Web site featuring a pretty woman.) And earlier this year Prolia was approved by the FDA for postmenopausal osteoporosis with a high risk of fracture. Do healthy people really want to suppress their body's tumor necrosis factor (TNF) and invite tuberculosis, serious, possibly lethal infections, melanoma, lymphoma and "unusual cancers in children and teenagers" as the Humira label warns? Nor is it clear these drugs work. The Humira label warns against developing "new or worsening" psoriasis -- a condition it is supposed to treat.


-- Chantix
How unsafe is the antismoking drug Chantix? After 397 FDA cases of possible psychosis, 227 domestic reports of suicidal acts, thoughts or behaviors and 28 suicides, the government banned pilots and air traffic controllers and interstate truck and bus drivers from taking Chantix in 2008. Four months later, some military pharmacies banned the drug, which reduces both cravings and smoking pleasure. In addition to Chantix' neuropsychiatric effects (immortalized by New Bohemians musician Carter Albrecht, who was shot to death in 2007 in Texas by a neighbor after acting aggressively), Chantix is linked to angioedema, serious skin reactions, visual impairment, accidental injury, dizziness, muscle spasms, seizures and loss of consciousness. In defending an increasingly indefensible drug, Janet Woodcock, director of the FDA Center for Drug Evaluation said last year, "Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit." True enough -- but if you smoke cigarettes you can still drive an interstate truck.

-- Ambien
Sleeping pills like Ambien, Lunesta, Sonata and Rozerem only decrease get-to-sleep time by 18 minutes according to the National Institutes of Health (NIH).

But Ambien has additional cachet compared to its soporific brethren: it is the drug Tiger Woods reportedly used when cavorting with his consorts; and former U.S. Rep. Patrick Kennedy was taking it when he crashed his Ford Mustang while driving to Capitol Hill in the middle of the night to "vote" in 2006.

In fact Ambien's legendary somnambulism side effects -- people walk, drive, make phone calls and even have sex while sleeping -- has increased traffic accidents say law enforcement officials, with some drivers not even recognizing arresting police. Thanks to bad Ambien press, Sanofi-Aventis has had to run ads telling the public to get in bed and stay there if you are going to take Ambien. (Or you'll break out in handcuffs, as the joke goes.) Ambien has also increased the national weight problem as dieters wake up amid mountains of pizza, Krispy Kreme and Häagen-Dazs cartons consumed by their evil twins.

-- Tamoxifen

Is it a coincidence that Tamoxifen maker AstraZenaca founded Breast Cancer Awareness Month and makes carcinogenic agrochemicals that cause breast cancer? Both the original safety studies of Tamoxifen, which causes cancer, birth defects and is a chemical cousin of organochlorine pesticides, and its original marketing were riddled with scientific error. In fact, FDA objected to AstraZeneca's marketing claim of breast cancer prevention and the casting of endometrial cancer as an "uncommon" event 10 years ago.

Yet today pharma-linked doctors still tell women to take Tamoxifen to prevent breast cancer even though an American Journal of Medicine study found the average life expectancy increase is nine days (and Public Citizen says for every case of breast cancer Tamoxifen prevents there is a life-threatening case of blood clots, stroke or endometrial cancer). A Gynecologic and Obstetric Investigation study shows an example of Tamoxifen's downside: 57.2 percent of women on continuous Tamoxifen developed atrophy of the lining of the uterus, 35.7 coexisting hyperphasia and 8.1 percent uterine polyps. We won't even talk about eye and memory problems -- or the Tamoxifen cousin, Evista, that pharma is also pushing which has a "death from stroke" warning on its label.

-- Boniva
Why is the bisphosphonate bone drug Boniva available in a convenient, once-monthly formulation? Could patients balk at the fact that after you take it you have to avoid lying down for at least 60 minutes to "help decrease the risk of problems in the esophagus and stomach," wait at least 60 minutes before eating or drinking anything except water, never take it with mineral water, sparkling water, coffee, tea, milk, juice or other oral medicine, including calcium, antacids, or vitamins, and of course, "do not chew or suck"? Nor should you take Boniva, say the warnings, "if you have difficult or painful swallowing, chest pain or continuing or severe heartburn, have low blood calcium or severe kidney disease or if severe bone, joint and/or muscle pain."

Bone drugs like Boniva, Fosamax and Actonel are a good example of FDA approving once-unapprovable drugs by transferring risk onto the public's shoulders with "we warned you" labels. The warnings are supposed to make people make their own safety decisions. Except that people just think FDA wouldn't have approved it if it weren't safe.


-- Prempro and Premarin
You'd think Pfizer's hormone drugs Prempro and the related Premarin and Provera would be history in light of their perks: 26 percent increase in breast cancer, 41 percent increase in strokes, 29 percent increase in heart attacks, 22 percent increase in cardiovascular disease, double the rates of blood clots and links to deafness, urinary incontinence, cataracts, gout, joint degeneration, asthma, lupus, scleroderma, dementia, Alzheimer's disease and lung, ovarian, breast, endometrial, gall bladder and melanoma cancers -- pant pant. But you'd be wrong. Even as we speak, Pfizer-linked researchers are testing the cognitive and cardiovascular "benefits" of hormone therapy, in some cases with our tax dollars, at major universities. Even though the cancer rate in the U.S. and Canada fell when women quit hormone therapy in 2002 (as did the U.S. heart attack rate in women), pharma is rolling out HT "Light" for women who suffer from the "ism" of incredibly short memory.