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.

Big Pharma Shamelessly Shills Dangerous Bone Drugs You Don't Need

Drugs meant to strengthen bones may not work -- and many have a slew of harmful side-effects like a higher cancer risk, irregular heart rate, and stomach bleeding.
By Martha Rosenberg, AlterNet
Posted on November 15, 2010

If you feel like everyone is warning you about your bones and imminent osteoporosis, you are right. Boniva, an osteoporosis drug which actress Sally Field says helps women "stop losing and start reversing" bone, is one of the top 20 most advertised drugs. Bone drug Evista was personally promoted by former FDA deputy commissioner for medical and scientific affairs under George W. Bush, Scott Gottlieb. And "novel" bone drug Prolia, also called a Frankendrug, received a Best New Drug award this week at the 2010 Scrip Awards ceremony.

While most of the world is now aware of the risks of osteoporosis, the problem with the bone drugs is: they may not work and women may not need them.

According to National Public Radio, Merck hired a company to whip up fears of "osteopenia," the risk of getting osteoporosis, to get women to take Fosamax, the first bisphosphonate bone drug launched 15 year ago. The hired guns creating the faux "Bone Measurement Institute," planted bone scan machines in medical offices and pushing the Bone Mass Measurement Act which made scans Medicare-reimbursable. By the end of the 1990s the "disease" of osteopenia had increased seven fold according to the Associated Press.

Even the term osteopenia, created by World Health Organization, was co-opted. It was never meant to be "a disease in itself to be treated," says Dartmouth Medical School professor Anna Tosteson who attended the WHO meeting, and the osteopenia diagnostic criteria were decided arbitrarily because the scientists were tired and wanted to adjourn.

Like Merck's Vioxx, Merck's Fosamax was launched ahead of schedule and its side effects -- esophageal erosion, bleeding, inflammation and perforation (why patients have sit or stand for an hour after a dose) -- only emerged when the drug was reimbur$able. In fact, Merck was forced to send out Dear Doctor letters months after Fosamax' 1995 approval and the FDA threatened to revoke approval altogether until Merck's head of research at the time, Edward M. Scolnick, convinced it to simply add a warning.

At the same time the clinical picture of bisphosphonates (Roche and GSK's Boniva and Procter & Gamble's Actonel followed) worsened.

It turned out the same mechanism that stops bone loss, suppression of the body's bone remodeling action, can cause bones to become brittle and at risk of breaking because they are not renewed. Since 2006, so many medical journal articles have chronicled spontaneous breaks of thigh and other bones on bisphosphonates, the FDA ordered a fracture warning to appear on the drugs' labels in October. Over a dozen women report their bones breaking while taking bisphosphonates on the drug rating site askapatient.com.

And there are other morbid perks with bisphosphonates.

Dentists and oral surgeons discovered that after simple office procedures patients' jaw bones would not heal but become necrotic and die. Whether Merck hid the jaw bone data, as some dentists claim, or didn't know because only two, three-year Fosamax studies were conducted, many dentists refuse work on bisphosphonate patients and an FDA-mandated jaw bone death warning went on the label. (Some Merck doctors blamed the jaw bone death on "bad oral hygiene.")

Intractable pain and atrial fibrillation, chronically irregular heartbeat, were reported with the bisphosphonates in medical journals and the FDA reported 23 US esophageal cancers and 27 in Europe and Japan in 2008. (Why does FDA put esophageal, fracture and jaw bone warnings on a drug also linked to cancers rather than simply withdraw it?)

But even as the FDA warned about bisphosphonate fractures last month, full page color ads in the New York Times offered women a new bone option: Evista, a Selective Estrogen Receptor Modulator (SERM) similar to the breast cancer drug Tamoxifen.

"You can take Evista at any time of day, with or without food," say the Eli Lilly ads without having to add "unlike SOME drugs we know."

Evista is approved for treatment and prevention of osteoporosis in postmenopausal women and reducing invasive breast cancer risk in other patient groups but it has its own negatives. Researchers at the University of Illinois and University of Southern California link it to ovarian cancer and its label warns about "increased risk of venous thromboembolism and death from stroke." Evista was originally promoted as reducing heart attacks and stroke. Oops.

Of 250 users on askapatient, 130 say they developed debilitating joint pain or muscle cramps on Evista, similar to bisphosphonates (though Evista rates higher than Boniva which is the lowest rated drug of 4,200.)

Many say they developed insomnia, memory loss, hair loss and eye problems -- SERMS are linked to cataracts -- but most alarming is: patients report losing bone density on a drug designed to preserve bone density.

And there's another macabre option for women's bone health. Amgen's Prolia, a monoclonal antibody derived from genetically engineered mammalian Chinese hamster ovary cells, was approved in June to prevent fractures in people with osteoporosis, two months earlier than expected.

Biologics are more lucrative for pharma than pills and lack generic competition -- Amgen's twice yearly Prolia injection costs $1650 per year -- but they suppress the immune system's tumor necrosis factor and cause malignancies, infections, tuberculosis and worse. During Prolia trials, 10 volunteers were hospitalized with the skin infection cellulitis and one died. Two monkeys died of protozoal infections on the drug and others developed tooth and jaw abscesses. (Jaw bone death is listed under Prolia's warnings and precautions.)

Immune-suppressing biologic drugs, broadly marketed for "RA," rheumatoid arthritis, which some say is pharma's next push, and to healthy college kids, are also associated with -- you guessed it!-- bone loss!

Of course no one is suggesting that fractures, especially in the elderly, are not a real problem. But increasingly doctors are looking at solutions other than bone drugs.

"The strongest single risk factor for fracture is falling and not osteoporosis," says a 2008 article in the British Medical Journal called Shifting The Focus in Fracture Prevention From Osteoporosis to Falls. "Despite this fact, few general practitioners will have assessed the risk of falling among their elderly patients or even know how to do it."

"Avoiding drugs that increase the likelihood of falling may be just as important as taking drugs that can make bones stronger," add People's Pharmacy authors Joe and Teresa Graedon, especially sedatives, sleeping pills and anxiety pills.

In fact many everyday pills like diuretics and anticoagulants can cause osteoporosis says an October article in The American Journal of Medicine.

A January British Medical Journal study of 68,500 younger women found calcium and Vitamin D reduced fractures by 50 percent while bisphosphonates exerted no action (unless you count that they "negate the effect" of the two supplements, according to the authors),

In fact, Vitamin D and calcium, given with placebo, actually outperformed Prolia in clinical trials.

Researchers are also looking at Vitamin K for osteoporosis protection and the elder plant, often taken to boost the immune system.

And then there's diet.

"There is growing evidence that consumption of a Western diet is a risk factor for osteoporosis through excess acid supply," says an article in the February Proceedings of the Nutrition Society. "Healthy adults consuming such a diet are at risk of chronic low-grade metabolic acidosis, which worsens with age as a result of declining kidney function."

Dean Ornish, Clinical Professor of Medicine at the University of California, San Francisco agrees. "For every gram of excess protein consumed (sulfur amino acid in particular) calcium loss is increased by 1 mg," he writes in a 2005 Journal of the American Dietetic Association. So do recent articles in the Journal of Bone and Mineral Research, Osteoporosis International, nutritionist Nathan Pritikin and probably Michael Pollan.

Long before bone drugs, the government supported "milk mustache" campaign warned teenage girls if they didn't drink milk they could get osteoporosis later in life, in 1993. Not that teens and tweens living with their parents worried about getting old or bone fractures.

A USDA expert panel threw out the bone benefit claims in 2001 but not before the Secretary of Health and Human Services herself, Donna Shalala posed for milk ads in 1998 and kicked off a "milk mobile" tour of 100 cities which offered free bone-density screenings.

The Center for Science in the Public Interest and fellows at the Brookings Institution objected to the government's top health official appearing in corporate advertising, but Shalala insisted that her promotion of the milk industry was to help the public prevent osteoporosis later in life. Today she