This is the year the APA puts the finishing touches on DSM-5, the Diagnostic and Statistical Manual of Mental Disorders, a compendium that determines what treatments insurers will cover, what disorders merit funding as “public health” threats and, of course, Pharma marketing and profits. Some question the objectivity of a disorder manual written by those who stand to benefit from an enlarged patient pool and new diseases. Furthering the appearance of self-dealing is the revelation that 57 percent of the DSM-5′s authors have Pharma links.

No kidding. Present at this year’s meeting were former APA president Alan F. Schatzberg, MD and Charles Nemeroff, MD, both investigated by Congress for murky Pharma income. Schatzberg and Nemeroff are co-editors of the APA-published Textbook of Psychopharmacology whose 2009 edition cites the work of Richard Borison, MD former psychiatry chief at the Augusta Veterans Affairs medical center who was sentenced to 15 years in prison for a $10 million clinical trial fraud. Also present was S. Charles Schulz, MD, who was investigated for financial links to AstraZeneca believed to alter his scientific conclusions.

Even though Assistant Secretary of Defense Jonathan Woodson sent a memo to all branches of the military in February about over-prescription of antipsychotic medications like Seroquel and Risperdal for PTSD, military figures closely linked to that over-prescription were also listed in attendance at the APA meeting.

Elspeth Ritchie, MD, told the Denver Post that AstraZeneca’s Seroquel was “very useful for the treatment of anxiety and combat-related nightmares,” though it was (and is) not approved for such treatment while she was medical director of the army’s Strategic Communications Office in 2008, participated in many symposiums. Ritchie, who is now chief clinical officer for the District of Columbia’s department of mental health, appeared in an AstraZeneca and Eli Lilly funded webcast for the Massachusetts General Hospital Psychiatry Academy in 2008 in which she lauds the use of “sophisticated” psychiatric medicines “on the battlefield.”¹

Seroquel earned AstraZeneca nearly $6 billion in revenue last year, reports the Philadelphia Inquirer. “IMS Health, a healthcare information and services company, said that in the 12 months ending in February of this year, 14.1 million Seroquel prescriptions were written, more than any other antipsychotic,” it reports.

Also participating in the military and PTSD content at the APA meeting was Matthew Friedman, MD, Executive Director of the VA’s National Center for PTSD who reported, “I received an honorarium from AstraZeneca in the past year,” in a 2009 government slide show called “Pharmacological Treatments of PTSD and Comorbid Disorder.” Friedman also served as a Pfizer Visiting Professor at the Medical University of South Carolina College of Medicine last year yet is listed in the APA meeting guide as having no “significant relationships to disclose.” APA officials have not responded to several requests for comment.

Of course, disorders that Big Pharma has helped monetize like bipolar (which was termed “under diagnosed” and emerging in the elderly at the meeting) and “mood disorders” (once called “life”) were well represented. But an alarming amount of attention also went to the apparent new Pharma profit center of alcoholism and drug addiction.

Addiction specialists have known for more than 70 years that the only “treatment” for drug addiction and alcoholism (after patients are detoxed) are anonymous, self-help programs that are also free. In fact, medicine is as powerless to understand or treat drug addiction and alcoholism as alcoholics and drug addicts are over their addiction.

Still the National Institutes of Health, in conjunction with Big Pharma, continues to spend millions, some say billions, developing “animal models” of addiction and vaccines to “cure” them. Nora D. Volkow, MD director of the National Institute on Drug Abuse, says she seeks a vaccine to treat those at risk of alcoholism and drug addiction on the basis of “biological and environmental factors,” before they get sick. (See: treating those “at risk” for psychosis or depression or bipolar disorder on the basis of their family histories with no symptoms evidence.)

It is pretty fair to say Volkow is not an alcoholic or drug addict. Any of them could tell her they don’t seek “help” until they’re out of options — and even then not from a doctor but from each other. In fact, if Pharma, the National Institute on Drug Abuse and the American Psychiatric Association think they can treat a disease caused by drugs with a drug, that’s pretty insane. In fact, one of the treatments suggested for alcoholism at the meeting was quetiapine, also known as Seroquel.

1. “The Returning Veteran: PTSD and Traumatic Brain Injury,” Massachusetts General Hospital Psychiatry Academy, May 28, 2008

Pharma is losing so much money from rising co-pays and prescription abandonment, it has launched cagey, public service announcement-sounding campaigns about “patients not taking the drugs they need,” as if it is a health and not revenue issue. Pharma has even instituted arrangements with some pharmacies to send visiting nurses to patients’ homes to ensure “compliance,” Big Brother overtones notwithstanding.

(Pharma has another PSA-sounding public relations campaign going on too: Patients are “abusing” prescription drugs! It’s not the billions Pharma spends advertising drugs that causes abuse — it’s patients.)

Prescription abandonment is an especially thorny issue for Pharma when the drugs are taken on faith, to reduce patients’ “risks” and patients do not necessarily feel them working. It is also a thorny issue when studies suggest the drugs being abandoned may not be necessary to begin with or working.

One such expensive placebo is the drug known by the brand name Risperdal. The Department of Veterans Affairs spent $717 million on the drug to treat post traumatic stress disorder in Afghanistan and Iraq troops with PTSD over nine years, only to discover it worked no better than a sugar pill! Veterans Affairs doctors wrote more than 5 million prescriptions from 2000 through June 2010 for naught, says a 2011 paper in the Journal of the American Medical Association (JAMA).

Nor was that the end of Pharma’s dupe of the government, taxpayers and veterans. Less than two weeks after the JAMA study was published, the VA awarded a contract for more than 200,000 bottles of generic risperidone, said published reports, containing more than 20 million pills.

While no one wants sick people to go without their drugs, some say the Pharma-concocted bills are designed to change the debate over the cost of exorbitant drugs to coverage issues over who pays for them — thus giving “the drug companies a free ride to charge as much as they want.” Pharma is even using patient front groups to whip up a contrived demand for expensive drugs, some charge.

Patients may seem to benefit from the proposed co-pay legislation but health care costs and taxes actually skyrocket as Pharma tries to pass along the cost of expensive brand name drugs that may not even be necessary and are often less effective than cheaper drugs. If they work at all.

An example of how Pharma is trying to play the co-pay card for its revenue stream is seen in a recent article in JAMA, called “Out-of-Pocket Medication Costs and Use of Medications and Health Care Services Among Children With Asthma.” Increased co-pay is resulting in less use of the asthma “controller medications” say the authors, who have links to Pfizer, Novartis and Bristol-Myers Squibb, three large drug companies. Asthma controller medications are drugs added on top of rescue inhalers or inhaled corticosteroids. They are well known, highly advertised drugs like Advair, Singulair, Symbicort, and Accolate.  But data published by Medco, the nation’s largest pharmacy benefit manager, says in a large group of patients studied, controller drugs reduce neither trips to the ER or hospitalizations. Worse, some reports say the controller asthma medications actually make asthma worse.

Do we really need laws written by Pharma to help “buy” drugs that may be worthless or even make us worse?

There’s even an upside to the parade of medical journal articles linking red meat to coronary heart disease and cancer deaths. As long as people are taking about beef’s ick factor and link to progressive diseases, they’re not talking about the “third rail” of meat safety – mad cow disease.

It’s has been almost ten years since the U.S.’s first mad cow was discovered. Ninety-eight percent of U.S. beef exports evaporated within 24 hours when Mexico, Russia, Brazil, South Africa, Hong Kong, Japan, Singapore, Taiwan, Malaysia, South Korea, and 90 other countries banned US beef. The only reason the European Union didn’t ban U.S. beef was because it had already banned it for excessive use of growth hormones!

Now the U.S. is trying to win back Japan and China’s business, not fully restored since the first U.S. mad cow, in a trade version of the golden rule or “turnabout is fair play.” Specifically, the U.S. would agree to resume beef imports from other countries it has hitherto banned because of their mad cow risk (like Britain, Ireland and the Netherlands) in the hopes that the U.S.’s holdout trading partners will do the same, under the proposed rule.

“Quite simply, this proposed rule will show the United States is willing to talk the talk and walk the walk with regard to following international standards developed by the World Organisation for Animal Health (OIE),” says National Cattlemen’s Beef Association Director of Legislative Affairs Kent Bacus. “It’s difficult for us to continue to demand that our trading partners comply with OIE standards when we don’t,” agrees Josh Winegarner, government relations director for the Texas Cattle Feeders Association.

But R-CALF USA, a national cattle group often at odds with the government, is unhappy with the impending we’ll-eat-it-if-you-do quid pro quo. “Exposing U.S. consumers and U.S. livestock to a heightened risk of BSE [mad cow] introduction is irresponsible and contrary to pledges made by the Obama Administration during his campaign,” says the group.

Under OIE criteria, countries can have “negligible”, “controlled”, or “undetermined” mad cow risks based on the strength of their feed bans (feeding ruminants-to-ruminants like cows to cows), control of animal imports from risky countries and disease surveillance. OIE gave the U.S. a surprising “controlled risk” status despite three identified mad cows but the classification failed to pry open closed export markets as hoped. In fact, trade officials now say the U.S.’s controlled risk status costs it $3 billion a year in foreign sales and are seeking “negligible risk” status.

Negligible risk status under OIE guidelines requires “there has been no case of BSE or, if there has been a case, every case of BSE has been demonstrated to have been imported and has been completely destroyed” and that safety measure have been observed for at least seven years. If a mad cow case or cases were home grown, a country can still seek negligible risk status, according to OIE criteria, if it can demonstrate that all cattle “reared with the BSE cases” and consuming the same potentially contaminated feed or all cattle born from the same herd are “permanently identified, and their movements controlled, and, when slaughtered or at death, are completely destroyed.”

But even under those circumstances, the U.S. doesn’t make the cut because herd mates and feed mates of the first U.S. mad cow were not “identified”, “destroyed” or had their “movements controlled” as required. Eleven out of 25 head of cattle which authorities considered “likely to have eaten the same potentially infectious feed” as the Washington state cow were never found says the Associated Press. The fail rate was considerably higher with subsequent U.S. mad cows.

Mad cow disease belongs to a family of fatal brain diseases or “transmissible encephalopathies” and is known as bovine spongiform encephalopathy (BSE) in cows, scrapie in sheep and goats and chronic wasting disease (CWD) in deer and elk. The diseases are thought to be transmitted by prions, invisible infectious particles that are not viruses or bacteria, but proteins.

Though prions are not technically “alive” because they lack a nucleus, they manage to reproduce. And though not technically “alive,” prions are almost impossible to “kill” or destroy because they are not inactivated by cooking, heat, ammonia, bleach, hydrogen peroxide, benzene, alcohol, phenol, lye, formaldehyde or radiation. In fact, alcohol makes prions more transmissible because it binds them to metal like surgical instruments. Nor is it safe to just dump prion material in landfills because prions endure in soil for years and contaminate it.

Many have heard mad cow scare stories like: people with Alzheimer’s disease really have variant Creutzfeldt-Jakob disease (vCJD), the human version of mad cow disease; dogs, cats, pigs and fish are at risk; mad cow is spread by flies and mosquitoes; and mad cow is in milk or cosmetics. But prions are scary enough without urban legends to embellish them.

In humans, mad cow prions can cause a fatal neurological disease called variant Creutzfeldt-Jakob disease (vCJD). But the government is quick to point out that humans get other forms of CJD that are not variant, including classic or sporadic – which occur spontaneously – and hereditary CJD – which is genetic. The government also says there are clinical and symptom differences between the two and that classic or sporadic CJD tends to strike the old (at an average age of 68) while vCJD tends to strike the young (the average age in Britain was 28). The problem is doctors don’t know which type of CJD a patient has without a brain biopsy, usually after death – just as veterinarians don’t know which cows have mad cow until after death.

On December 23, 2003, as the nation headed into Christmas, the USDA announced that a Holstein cow, imported from Canada and slaughtered in Moses Lake, Washington, on December 9 for human food, tested positive for mad cow disease. Ann Veneman, agriculture secretary and other USDA officials said the cow was discovered because she was a “downer” (unable to walk), indicating that the mad cow testing program worked since it screened downers as the main source of mad cow risk. But three workers who saw the animal said it walked just fine.

What followed, believe it or not, were congressional hearings, a federal criminal investigation, and a General Accounting Office (GAO) investigation largely over whether or not the animal walked to slaughter. Because if the animal looked fine and walked under its own steam to slaughter, the entire federal mad cow testing program was misconceived and was letting millions of similar animals into the food supply. But if the slaughterhouse workers were lying, as the government hoped, and the animal was prodded or fork-lifted to slaughter, we might have a farming system that values money over living things and chews them up and spits them out, but at least the mad cow alert system works.

In testimony before Congress, USDA inspector general Phyllis K. Fong blamed “procedural errors” for the conflicting data about whether or not the animal walked, and said an employee “who alleged that the BSE-positive cow was ambulatory and healthy when it arrived at the facility described a different animal from the one that arrived in the same trailer and later tested BSE-positive.”

Unfortunately, that was not the only government discrepancy. There were also two very different versions of what happened to the meat from the Washington state cow. The government said in its final report that, “By December 27, 2003, FDA had located all potentially-infectious product rendered from the BSE-positive cow in Washington State. This product was disposed of in a landfill in accordance with Federal, State and local regulations.”  But the Los Angeles Times reported that despite “a voluntary recall aimed at recovering all 10,000 pounds of beef slaughtered at the plant the day the Washington state cow was killed, some meat, which could have contained the Washington cow, was sold to restaurants in several Northern California counties.” And eaten, it turns out.

“In an interview, Alameda County health officer Dr. Anthony Iton recalled that in early January 2004, almost a month after the initial discovery, state health officials informed him that five restaurants in the Oakland area had received soup bones from the lot of tainted beef,” says the Times. “It immediately dispatched inspectors to the restaurants. But it was too late; soup made from the bones had been eaten. He was particularly disturbed to learn that none of the restaurant owners had received written notice of the recall and that federal inspectors did not visit them until 10 days after the recall.”

There was a second affront to food consumers besides letting the mad cow into the food supply and lying about it: bound by a USDA rule, the California Department of Health Services did not release the identities of stores or restaurants that purchased the meat, reported the San Francisco Chronicle. “Alameda and Santa Clara counties have been informed by the state that 11 local restaurants and a market purchased soup bones from the suspect lot, but they have also declined to identify which establishments purchased them,” said the Chronicle. “The U.S. Department of Agriculture insists the recall is precautionary and the meat poses no health risk.”

USDA spokesman Matthew Baun actually said it was the public’s responsibility to find out if any food they ate was at risk because the recall information was a trade secret! It is “up to consumers to check with their grocers, butchers or restaurants to find out if any of the recalled meat may have landed on their tables,” said Baun. “We are prohibited from releasing information that companies would consider proprietary. If you are concerned whether you may have purchased the product, you can call your retail store. They would know. . . . The only way to know for sure is to contact stores.”

Being “concerned” whether you “purchased” a product that could cause certain death struck the public as a glib understatement and four years later similar outrage over  government shielding of outlets selling meat from sick and abused cattle killed for the National School Lunch Program at Westland/Hallmark Meat Company in Chino, California prompted the USDA to reverse its policy protecting sellers, if not growers, of dangersous meat.

More Mad Cows and More Damage Control

Because of suspicions that feeding ruminants-to-ruminants and making cows cannibals could cause or spread mad cow disease, the U.S. had already banned the “protein recyling” practice in 1997. But one week after the Washington state mad cow surfaced, the USDA strengthened controls against mad cow disease by banning downer cattle in the food supply. It also banned “specified risk material“(SRM) from cows in the human food supply which included brains, skulls, eyes, spinal cords, tonsils, spleens, lymph tissues, and most of the vertebral column and small intestine, said to be at highest risk.

While scientific literature suggests that all cattle tissue, not just SRM, can harbor BSE infectivity, the government submits that “the presence of PrP [BSE] does not necessarily indicate the presence of BSE infectivity,”–meaning it may be in the meat but you may not catch it. Not too reassuring.

Japan and South Korea, two of the U.S.’s top-three beef importing nations were also not reassured by the new safety controls and withheld their business. And even as Mike Johanns, who succeeded Ann Veneman as agriculture secretary, tried to woo back Japan’s $1.5 billion a year business and South Korea’s $800 million,¹ the unthinkable happened. A second mad cow was found in the U.S. and unlike the first cow, which had been born in Canada, the second cow had never left its Texas ranch.²

Worse, the 12-year-old “cream-colored Brahma cross” had been suspected of mad cow eleven months after the Washington cow, but the government did not tell the public until seven months later. It took the government three tests to identify the cow as positive, the last test unilaterally ordered by USDA Inspector General Phyllis Fong over Johanns’ head. Asked why the United States’ best technology was missing mad cows Johanns conceded to reporters that prion distribution in a brain could make “it possible for one sample to test negative while another sample might test positive,” reported the Houston Chronicle. He also conceded that “the protocol we developed just a few years ago to conduct the tests, including the type of antibody used, might not be the best option today.”

And there were other disturbing facts. The cream-colored Brahma cross was sold at a livestock sale despite reports that she was a downer. (“The cow had always been excitable and had fallen while she was being loaded to go to the market, but that this was not unusual behavior for her,” the owner told government investigators.) The buyer sent the Brahma cross to the slaughterhouse four days later, but when the truck arrived at H&B Packing in Waco, she was dead and the truck turned around and transported her instead to Champion Pet Food, across town. And 350 of her possible herd mates and offspring were slaughtered “and possibly in the human food supply, even before the government inquiry began,” reported the Dallas Morning News. The cow’s owner was “relatively sure” he had not kept any offspring from the cow at the facility but “there were essentially no records maintained on the index farm,” reported the government.

Yet despite selling an animal that couldn’t walk for human food, maintaining no records and the business’ very murky ownership, according to the government, the identity of the ranch and its owner was protected. Even more outrageous, the ranch was cleared to resume selling meat within one month. Why should a livestock operation be penalized for producing food that could kill people?

Meanwhile, the trading relationship with Japan was roiling. One month after Japan agreed to start importing U.S. beef again in early 2005, SRM – specified risk material -was found in a U.S. beef shipment and the ban was immediately re-imposed. Oops. The USDA conducted a self-policing “export verification audit” to reassure Japan and it just made things worse. Nine slaughterhouses were found in noncompliance with SRM policies, according to the audit, and 29 downers went into a human food supply, 20 not tested for mad cow disease. The reason the cows were not tested for mad cow almost sounds like a joke. Government inspectors “did not believe that they had the authority” to go into the pens where the animals were held and get samples, reported the Houston Chronicle.

In answers to written questions from Japanese agriculture officials, Johanns said the 29 cattle were healthy until they arrived at the slaughterhouses, “where they suddenly became unable to walk because of injury or other factors,” reported Eiji Hirose of Yomiuri Shimbun/Daily Yomiuri – kind of like the Texas rancher’s “excitable” cow. Legally, downers could be slaughtered for food if they had suffered an acute injury after passing inspection. But Johanns did not give any “clear evidence for his conclusion,” wrote Hirose, and his overall comments appeared “to show the U.S. government does not take the issue seriously enough.” Japan’s agriculture minister, Shoichi Nakagawa, was similarly unappeased and told Johanns in a phone conversation, he was concerned about SRM and downer cows. Japan then sent a team of officials to inspect US slaughterhouses firsthand.

Can anyone guess what happened next? Even before Japanese inspectors arrived in the U.S., another mad cow was found. On March 13, 2006, a deep-red, crossbred beef cow from an Alabama ranch, estimated to be ten years old, became the third confirmed U.S. mad cow.

Like the Texas cow, the Alabama cow was a downer, initial tests failed to disclose her mad cow status and the identity of the Alabama ranch and its owner were protected. Also, like the Texas cow, she had recently given birth – she “had at her side a 2- to 3-week old red Charolais cross female calf” at the time of her death, said the government report – and her herd mates were not found or kept out of the food supply, though 37 farms were investigated.

The audit for Japan and mishandling of the first three mad cows are not the only red flags for U.S. beef safety. Lester Friedlander, DVM, a USDA federal meat inspector for 10 years, told United Press International in 2005 that a USDA official told him not to say anything if he ever discovered a case of mad cow disease, and that he knew of cows that had tested positive at private laboratories, but were ruled negative by the USDA.

And a 2008 Food Safety and Inspection Service (FSIS) report to assess safe removal of specified risk material (SRM) in U.S. slaughterhouses found the same equipment was being used at one facility on animals at high risk of mad cow and other animals because, according to the supervisory public health veterinarian, “there were no ‘visible SRMs’ on the equipment,” as if prions could be seen. The government report also says FSIS Headquarters officials “believed the sanitizer spray was sufficient to address the problem,” as if prions aren’t practically indestructible. Maybe it was even alcohol.

Cluster Bombs

Even before the 2003 Washington state cow, agribusiness recognized the damage that rumors of mad cow or other lethal agents in the food supply could do and lobbied lawmakers to pass food disparagement laws in the late 1990s. Oprah Winfrey herself was tried in Amarillo in 1997 for “disparaging” beef when she remarked on her show that she would never eat a hamburger again after learning of the forced cannibalism on U.S. farms, causing cattlemen to lose $11 million when prices plummeted. She was acquitted.

Since the three U.S. mad cows, beef producers and officials are quick to reassure the public when CJD cases surface that the brain diseases are not variant CJD from eating meat. Still, the damage control is tough when cases occur in clusters since sporadic or classic CJD by definition occur randomly and not in clusters.

Soon after the Washington state cow, the Centers for Disease Control and Prevention (CDC) investigated a potential cluster of more than 13 CJD cases, thought by some to be linked to food served at the Garden State Racetrack in southern New Jersey. But the CDC issued a report that found five of the cases were sporadic CJD, not variant CJD; six were “probable” CJD but not variant; three were not CJD; and three were still under investigation. The occurrence of 14 CJD-related cases over 9.25 years “would not be unusual,” said the CDC.

Apparent clusters of nine people in Idaho in 2005³ , four in northeastern Indiana in 2007 and two in Tennessee in 2009, were similarly smoothed over. And when a CJD patient was admitted to an Amarillo, Texas hospital in 2008 causing cattle futures to tank, a beef-cattle specialist with the Amarillo office of Texas AgriLife Extension assured the public the case was sporadic not variant – before test results were even in. Two years later, there were more questions about CJD cases in Texas. A map of “CJD Cases by County 2000–2010″ on the Texas Department of State Health Services website shows two red areas that look like, well, clusters.

Nonetheless, Americans seem less rattled about beef scares than are countries they export to. As the U.S. and South Korea prepared to sign the free-trade agreement, KORUS FTA, in 2008, which included wide provisions for beef trade, actual riots over the risk of mad cow in U.S. beef broke out in South Korea. “We Don’t Like the FDA,” “Mad Cow, You Eat It!” and “Send Mad Cow to the Presidential Office!” chanted demonstrators at candlelight vigils in 22 cities, some dressed in cow costumes.

Fueling the riots were reports in local media that Koreans are genetically more vulnerable to vCJD, that mad cow prions were in cosmetics, diapers and sanitary napkins and television images of downer cows at Westland/Hallmark Meat Company in Chino, California fork-lifted and “water-boarded” to slaughter for National School Lunch Program a few months earlier. And even as President George W. Bush assured South Korean president Lee Myung-bak at Camp David during the trade negotiations that U.S. beef was safe, a case of CJD appeared in a 22-year-old Virginia woman who had never left the country. It was an unusually young age for CJD if it weren’t variant.

As the U.S. now seeks “negligible risk” status for mad cow disease, there’s no reason to believe its institutionalized ineptitude, denial and misinformation about beef risks has changed and therefore that such a classification means anything. In fact, there is only one government safeguard that beef consumers can count on: if more mad cows surface, the names of the ranches that produce them will be protected.

An earlier version of this report appeared on Truth-out.org

1. Art Hovey, “Cattlemen leery of reopening border”,  Lee Newspapers, February 10, 2005
2. Betsy Blaney, “Cattle Herd Must Stay Put—Texas Ranch Where Diseased Cow Originated Is Quarantined,” Associated Press, July 1, 2005
3. Rare Disease Raises Questions—Idaho Cases of Creutzfeldt-Jakob, Herald Journal, October 23, 2005

The label on the malaria drug, developed by the Walter Reed Army Institute of Research in the 1970s after another malaria drug used in Vietnam failed, warns of psychosis, hallucinations, delusions, paranoia, aggression, tremors, confusion, abnormal dreams and suicide.

Military officials blamed the Fort Bragg murders on marital problems and combat stress — explanations already heard with Army staff sergeant Robert Bales, suspected of killing 16 Afghan civilians this month, 17 by some reports.

But soon after the Fort Bragg killings other soldiers given Lariam spoke out.  A 27-year old Air Force Staff Sgt. named Kevin based in Little Rock, who only gave his first name, told United Press International he too experienced delusions, hallucinations, blackouts and frightening flashes of anger after taking just five doses of Lariam.

“These guys who killed their wives and then themselves (near Fort Bragg). If they were having a reaction to Lariam I can totally understand why they did it. The patience level goes way down. You feel confused, and the anger and frustration level goes way up,” Kevin said. “The only reason I have not done anything to myself yet is because I think it is a one-way ticket to hell.”

Even lawmakers doubted Lariam’s safety. “Our military said there is no problem with (Lariam) because they developed it,” remarked Rep. Bart Stupak, D-Mich when an Army report about the Fort Bragg killings discounted Lariam as a factor. “The hardest thing to do is develop a drug and then admit there is a problem.”

One side effect of Lariam can be abrupt personality changes. A seventeen-year marine veteran serving in Afghanistan in 2009 and given Lariam, “went from being loving on the phone, to saying he never wanted to see me and our daughter again,” said his wife in an interview. “He said not to even bother coming to the airport to meet him, because he would walk right past us.” When the couple did reunite, her husband was frail and thin, and “the whites of his eyes were brown,” says the wife. The formerly competent drill instructor became increasingly unpredictable, suicidal, and violent and was incarcerated in the brig at Camp Lejeune for assault in 2011.

In her nonfiction book, Murder in Baker Company, Cilla McCain also speculates whether the use of Lariam might explain, or partially explain, the brutal actions of the soldiers accused in the death of Army Specialist Richard Davis in 2003.

The Air Force bans pilots from using Lariam and the Army says it is substituting a safer drug, but the Navy and Marine Corps have actually increased prescriptions for Lariam the Associated Press reported last year. And, “numbers could be higher still because prescriptions filled overseas are frequently not counted.” The effects of Lariam can last for “weeks, months, and even years,” after it’s stopped, warns the VA. The drug “should not be given to anyone with symptoms of a brain injury, depression or anxiety disorder,” reported Army Times, which describes “many troops who have deployed to Iraq or Afghanistan.”

A medical presentation about Lariam by Army major Dr. Remington Nevin on YouTube links Lariam to seizures, PTSD effects, extreme and unexpected reactions and probable permanent brain toxicity. Like “angel dust” Lariam is associated with incredible acts of violence and self-mutilation, marked by depersonalization — the feeling that someone else is committing the acts — and tissue binding in which the drug remains stored in the body long after it is taken. Lariam, not only intensifies PTSD, it intensifies PTSD drugs and makes them more dangerous, says the presentation.

How widespread is the use of Lariam among troops? Why is it in use at all?

Why the milk drinking nosedive? First, many U.S. groups from ethnic minorities, the lactose intolerant and allergic to dieters, the health conscious and vegans simply do not drink much, or any, milk. Kids themselves often dislike milk–probably why they invented chocolate milk–and it is often the last choice among teens and tweens–on whom much milk marketing is focused. Health care professionals, unless subsidized by the dairy industry, seldom recommend milk because of its cholesterol, fat, calories, allergens and impurities and its possible links to rBGH (recombinant bovine growth hormone) since milk made with the cow milk enhancer has never been labeled.  Benjamin Spock, MD, the famous baby boom–era pediatrician, recommended no milk for children after age two to reduce their risks of heart disease, obesity, high blood pressure,  diabetes, and diet-related cancers.

Milk marketers admit that the public’s “preference” for milk may be changing, but also blame calcium-fortified juices and vitamin-enhanced beverages that  “undermine” milk’s healthy image and “limited availability” of milk in eating establishments and even milk’s price. You can’t find milk anywhere — and when you do, you can’t afford it! The agencies also note that national milk sales are falling as the “proportion of African Americans in the population increases”– a group not known to be big milk drinkers — and because the proportion of children under six has not grown much.

Milk marketers have tried everything to reverse falling sales. During the 1980s when the slogan was “Milk: It Does a Body Good,” they began marketing milk for strong bones and to prevent osteoporosis. “One in five victims of osteoporosis is male,” said milk ads featuring  model Tyra Banks, as the mustache campaign debuted. “Don’t worry. Calcium can help prevent it.” Another early mustache ad with musician Marc Anthony read,  “Shake it, don’t break it. Want strong bones? Drinking enough low fat milk now can help prevent osteoporosis later.”

But there were both marketing and scientific problems with the campaign. Teens and tweens don’t worry much about old people diseases whether osteoporosis or skin damage from sun exposure because who’s gonna get old? And African Americans, Latinos and men, groups targeted in the strong bone campaign, are the least at risk for osteoporosis say doctors. Oops!

Health professionals also disputed the bone claims themselves. A 2001 USDA expert panel report said that calcium intake by itself , as milk offers, does not prevent osteoporosis because exercise and nutrients other than calcium are part of the bone health picture. Panelists also said whole milk could increase the risk of prostate cancer and heart disease and ads should include such warnings.

And other experts like T. Colin Campbell, Ph.D., author of The China Study and heart expert Dean Ornish, M.D, of the Preventive Medicine Research Institute, agreed that osteoporosis and fractures are not caused by what marketers were presenting as “milk deficiencies.” In fact, the Western diet itself, which often has too much protein and acid, is blamed by some researchers and nutritionists for osteoporosis and fractures. The popular proton pump inhibitors like Nexium, Prevacid and Prilosec, which people take for acid reflux, are also blamed for fractures.

Undaunted, in 2002, milk marketers told Congress they were marketing the scientific benefits of milk for osteoporosis, breast cancer and hypertension and especially focusing on African Americans.

“The Fluid Milk Board continues to spotlight the high incidence of high blood pressure among African Americans and to promote milk and milk products as a dietary solution as part of the DASH [Dietary Approaches to Stop Hypertension] diet,” says the report to Congress. “The program also addresses misconceptions about lactose intolerance and shows why it should not be a barrier to including milk in the diet. The Board launched a new lactose intolerance initiative that focuses on educating African Americans on the importance of incorporating milk into their diet. The programs provided educational material on osteoporosis and lactose intolerance.”

Milk marketers also seemed to take a cue from the cartoon character, Joe Camel, used by R. J. Reynolds to market Camel cigarettes, and made milk more fun. Milk containers were redesigned into new hand-friendly decanters, called the Chug and a spoof-y musical group was rolled out on YouTube and social-networking sites called White Gold and the Calcium Twins.

http://www.spinner.com/2008/05/12/milk-strikes-white-gold-with-new-ad-campaign/ The “Got Milk?” site also ran an animated cartoon of a farm which depicted happy cows, chickens, ducks, and pigs (and a horse working out on a treadmill), while milk cartons moved by on a conveyor belt. A helium balloon pops up continually, saying, “Tell Your Friends.” (no Web link anymore)

“Do you think drinking calcium fortified beverages like soy drinks and orange juice will meet your bones’ requirements?” asks the  site. “Not really, says research that concluded 75 percent of calcium added to popular beverages gets left at the bottom of the carton.” But then, a disclaimer pops up and confesses that milk’s actual benefits for “bones, PMS, sleep, teeth, hair, muscles [and] nails” have been “purposefully exaggerated so as not to bore you.” What?

And that’s the least of the student marketing. Posters of mustache-wearing actors, sports figures, musicians, and models are sent to sixty thousand U.S. elementary schools and forty-five thousand middle and high schools and ads appear in Sports Illustrated for Kids, Spin, Electronic Gaming, CosmoGirl, Blender, Seventeen and elsewhere.

Students have been told if they visit milk websites, they can win an iPod, a Fender guitar, clothes from Adidas and Baby Phat and their schools could qualify for sports gear, classroom supplies, and musical instruments. There was also peer-to-peer, in-class selling at three California schools where students got a chance to create their own “Got Milk?” campaigns and qualify for an all-expense-paid trip to San Francisco to present their ideas to milk officials for future milk marketing campaigns.

The cost of an ad campaign guaranteed to sell milk to teens because it was created by teens? Priceless.

In 2005, milk marketers tried to widen the demographic by positioning milk as a cure for premenstrual syndrome, commonly called PMS. TV ads showing bumbling boyfriends and husbands rushing to the store for milk to detoxify their stricken women. But the study on which the campaign was based, credited calcium, not milk, with relieving PMS — a substance found in many sources besides milk (including the “calcium-fortified juices” that milk marketers battle against). And when milk marketers tried to revive the PMS campaign in 2011, the second time around it elicited  a tsunami of sexism charges and had to be scrapped.

Then, milk marketers sought an even wider demographic by rolling out the idea of milk as a diet food. “Studies suggest that the nutrients in milk can play an important role in weight loss. So if you’re trying to lose weight or maintain a healthy weight, try drinking 24 ounces of low-fat or fat-free milk every 24 hours as part of your reduced-calorie diet,” said the ads. The diet campaign was especially targeted to the Hispanic community, which is known both for its high obesity rates and its low milk consumption. There was even a related school program called “Healthiest Student Bodies,” which recognized twenty-five schools around the country for providing “an environment that encourages healthy choices for students.”

The milk-as-a-diet-food campaign had many catchy slogans — “Milk Your Diet,” “Body by Milk,” “Think about Your Drink,” “Why Milk?” “24oz/24hours, 3-a-Day” (and, of course, “Got Milk?”) — and the help of hotties Elizabeth Hurley and Sheryl Crowe modeling mustaches.  But soon after it debuted,  a study of twenty thousand men who increased their intake of low-fat dairy foods found they did not lose weight. “The hypothesis that has been floating around is that increasing dairy can promote weight loss, and in this study, I did not find that,” said researcher Swapnil Rajpathak, MD, assistant professor in the Department of Epidemiology and Population Health at the Albert Einstein College of Medicine. Worse, the research behind the weight-loss claims was largely conducted by Michael Zemel, Ph.D, director of the Nutrition Institute at the University of Tennessee, who had “patented” the claim that calcium or dairy products could help against obesity. The patent was owned by the university and licensed to Dairy Management Inc., reported USA Today.

The milk-as-a-diet-food suggestions also did not sound like they would produce weight loss. They included, “Make soups and chowders with milk,” “Add milk to risotto and rice dishes for a creamier texture,” and “Order a milk-based soup like corn chowder, potato leek or cream of broccoli as a first course at dinner.” What is the next course– a stick of butter?

Soon the Federal Trade Commission’s (FTC) Bureau of Consumer Protection directed milk marketers to stop the weight-loss campaign “until further research provides stronger, more conclusive evidence of an association  between dairy consumption and weight loss.” Milk marketing materials stopped claiming that milk makes drinkers lose weight, instead saying it doesn’t necessarily add weight – which is pretty different. They also retooled their claims to say that milk may have “certain nutrients that can help consumers meet dietary requirements”—pretty much the definition of “food.”

In February, milk marketers went for an even wider demographic — the set of all people who eat little or no breakfast — or at least a breakfast without milk. Using the bilingual actress Salma Hayek as pitchwoman, the new campaign, called the Breakfast Project, also targets  Spanish speaking communities with ads in People en Español and Ser Padres magazines and on the Univision morning show “Despierta América” as well as on English speaking media. “It’s Not Breakfast Without Milk,” say the new slogans; “Because Every Good Day Starts With Milk,” and “Hello, Sunshine.”

Like other milk marketing campaigns, the Breakfast Project is upbeat, interactive, inclusive and fun, offering recipes, tips, a “morning survival guide” and even a chance to win free milk. And like the other campaigns, it has little chance of selling a product people don’t particular like which is not particularly good for them. We won’t even talk about the filth and cruelty of modern dairy farms and what happens to veal calves, a “byproduct” of the industry to keep cows lactating.

Still, milk marketers seem to have learned one lesson from the disproved osteoporosis, PMS and weight loss claims of past campaigns: the Breakfast Project makes no appeal to science or medicine to support the marketed milk benefits. Instead of “studies have shown,” or “research has revealed” the new campaign simply says, “We believe milk is part of getting a successful day started.” Of course, they believe it, they are the dairy industry. Have they ever lied to us?

•  An earlier version of this story ran on Alternet.org.

A similar Big Pharma bubble, leavened with risky blockbuster drugs that also blew up, is now bursting. Like Wall Street’s bundled high risk loans, the “tide” created by Big Pharma’s high risk drugs raised many ships during the 2000s from advertising, public relations and medical communication agencies to TV and radio stations, medical journals and doctor/pitchmen who shoveled in its marketing budgets. But now the joy ride is over and Pharma is shedding jobs and settling billions in claims without changing its risky business model, like Wall Street.

In Europe, governments are no longer willing to pay the high prices for drugs that they once did say published reports and some countries are drafting laws making drug makers “prove their drugs are effective or risk having them dropped from the coverage list, or covered at a lower rate.” Imagine!

Germany has already saved 1.9 billion euros in 2011 by refusing to pay higher prices for drugs unless they are clearly superior to existing medicines, and Pharma worries that other countries will also get tough and want scientific proof for drug effectiveness instead of marketing and spin. In the U.S. and elsewhere, a drug only needs to be superior to no drug (placebo) to be approved by regulators — yet “new” is conveyed as “better than any drug to date” in advertising.  Some clinicians say Haldol, an inexpensive antipsychotic, and lithium, a similar affordable bipolar drug are better than blockbuster antipyschotics and bipolar drugs that created Pharma’s 2000 bubble.

Before the Vioxx scandal and major settlements over blockbuster drugs like Zyprexa, Bextra, Celebrex, Geodon and Seroquel, being a Pharma rep was probably the next best thing to working on Wall Street. Direct-to-consumer advertising did your pre-sell for you, and all you had to do was show up with your snappy Vytorin tote bag and samples case. Some Pharma reps had their own reception room with ice water, swivel chairs, and laptop ports at medical offices, and most waltzed in to see the doctor right in front of waiting and sick patients. (It didn’t hurt that reps were usually “hotties,” both men or women).

But, by 2011, the bloom had fallen off Pharma reps’ roses. The number of prescribers willing to see most reps fell almost 20 percent, the number refusing to see all reps increased by half, and eight million sales calls were “nearly impossible to complete,” reported ZS Associates. Blockbuster drugs that were found to be unsafe after their big sales push or even withdrawn altogether, did not help the reps’ credibility with doctors. After the aggressively marketed hormone therapy was linked to high incidences of cancer, stroke and heart attack, Wyeth (now Pfizer) announced it was eliminating 1,200 jobs and closing its Rouses Point, New York plant where Prempro products were manufactured.

As government and private insurers increasingly say, “You want us to cover what?” about expensive, dangerous drugs that are not even proven effective, Pharma bubble jobs are evaporating. Almost 20,000 jobs have vanished at AstraZeneca, Novartis and Pfizer in the last 12 months alone. (AstraZeneca scrapped 21,600 more since 2007). Meanwhile, Pharma is outsourcing more of its operations to poor countries.

Workers and people willing to be trial subjects are both a bargain in poor countries where many can’t understand drug risks or refuse them if they did (and most can’t afford the very drugs they help sell). In January the Argentinian Federation of Health Professionals accused drug maker GlaxoSmithKline of misleading participants and pressuring poor families into joining a trial for the Synflorix vaccine, which the company says protects against bacterial pneumonia and meningitis, reported CNN. In 2010, 10 deaths occurred during Pfizer and AstraZeneca drug trials at the Bhopal Memorial Hospital and Research Centre which was ironically built for survivors of the 1984 Bhopal gas disaster, reports MSNBC. 3,878 workers perished in Bhopal when chemicals leaked at a Union Carbide pesticide plant.

Outsourcing drug manufacturing to cheap venues also contributes to Pharma’s cascade of “quality control” problems in which drugs are mislabeled, contaminated or otherwise made dangerous. It is speculated that Johnson & Johnson’s CEO William Weldon “was pushed to retire because of all of the quality issues at McNeil as well as with the company’s hip implant products, which have resulted in a raft of litigation,” reports FiercePharma.

Like the Wall Street bubble, the Pharma bubble was built on products that industry, but not the public, knew were risky, sold for quick profits. Now regulators are examining some of these “assets” more closely and with disturbing findings. The FDA now warns that bestselling statin drugs like Lipitor and Crestor, even approved for children, are linked to memory loss and diabetes associated with. The equally well selling proton pump inhibitors like Nexium and Prilosec for acid reflux disease (GERD) are now believed to increase the risk of bone fractures by 30 percent.

In March, the FDA even rejected a Merck drug that combines the active drug in Lipitor with the active drug in Zetia and Vytorin, a drug that Forbes calls Son of Vytorin. Vytorin (the father) was advertised to treat both food and family “sources of cholesterol” until results from a study that Merck and Schering-Plough appeared to withhold from regulators showed the drug had no effect on the buildup of plaque in the arteries (believed to correlate with heart attack and stroke). There was such a gap between marketing and science, Sen. Chuck Grassley (R-Iowa) asked the General Accounting Office to investigate why the FDA was approving “drugs that appear to have little to no effect in protecting lives and increasing health.”

Yet even as clouds develop over Pharma’s top-selling drugs, some say the FDA is too hard on new drugs, not too easy. “The FDA is impeding useful innovations in the U.S.,” says former FDA deputy commissioner Scott Gottlieb in the a Wall Street Journal oped and lagging behind other countries. Former FDA commissioner Andrew Von Eschenbach, also writing in the WSJ, agrees. The FDA should improve U.S. drug competitiveness by allowing drugs “to be approved based on safety, with efficacy to be proven in later trials,” while the public is already taking the drugs. Isn’t that what’s happening now?

Butterball is certified by the British Retail Consortium, says the site, on “300 elements related to food safety and quality, as well as worker safety, environmental impact and management commitment.” The turkey processor practices “good citizenship” based on “self-governance,” “social responsibility,” and  “sustainability.”

But search for the words “welfare,” “Mercy For Animals” or “Shannon, North Carolina” (where a grisly Christmas-time expose took place) and you will get no results. Maybe you didn’t spell the words correctly.

Between November and December of 2011, while people were making their holiday plans, an undercover employee at a Butterball turkey semen collection facility in Shannon documented turkeys with open sores, infected eyes and broken bones, covered in flies and living in their own waste. Happy Thanksgiving everyone!

“In the video, workers can be seen kicking and stomping on turkeys, as well as dragging them by their wings and necks,” reported ABC news. “The video also shows injured birds with open wounds and exposed flesh.”

Birds at the Butterball facility were left to slowly die from their injuries, some unable to even reach food or water, says the undercover employee. The “pain and the suffering that they’re experiencing,” is clearly visible she told NBS news.

Like scores of other gigantic food producers who have been exposed on undercover videos as harboring sadistic employees and sick and dying animals, Butterball pleads ignorance. It has a “zero tolerance policy for any mistreatment of our birds,” and has fired the proverbial “bad apple” employees it did not know about. Who knew?

Butterball is also “taking steps to help ensure that all new and existing associates have a clear understanding of our animal well-being policies,” said Rod Brenneman, president and CEO of Butterball. Maybe employees don’t know they aren’t supposed to stomp and kick birds, drag them by their wings and necks, not to mention bash them in the heads with metal bars, as the employee reports. Let’s tell them!

But, it wasn’t only Butterball management that enabled the agricultural hell for turkeys in the interests of cheap “holiday” food. Dr. Sarah Mason, head of animal health programs in the North Carolina Department of Agriculture, tipped off Butterball about a December 28 raid and managed to sabotage it.  Even as the Hoke County Sheriff’s Department sought to raid Butterball on the basis of videotaped evidence, Mason contacted “a friend and fellow veterinarian” who works for Butterball, which assured that the raid “never had a chance,” reports the Fayetteville Observer.

Hey, from one vet to another, we better hide the animal abuse we’re permitting!

Given that the state agency is in charge of regulating Butterball yet undermined the raid, was there a quid pro quo involved? “That’s a criminal matter, to be decided by the district attorney’s office,” opines the Observer.

The sordid collegiality between government and industry which makes a mockery of democracy, consumer rights and animal welfare, brings to mind the saga of egg don Austin “Jack” DeCoster, the salmonella king.

Despite the recall of half a billion salmonella-contaminated eggs from DeCoster-affiliated farms in 2010, his conviction on animal cruelty,  the same year and nine deaths and 500 illnesses traced to his eggs in 1987,  Iowa state agencies thought he was a pretty cool dude.

“One of the things I’ve always said about DeCoster is that when there’s a problem at his facilities, he acts fast,” enthused Kevin Buskins, a spokesman for Iowa’s Department of Natural Resources which shares oversight of egg operations with the state agriculture department.

Will Butterball get a pass like DeCoster did? So far no charges have been filed against the turkey processor and its state regulator “friend” still has her job. And there is even more good news for the turkey processor. The company and its communications agency, Howard, Merrell & Partners, received four public relations awards from the Virginia Chapter of the National Agri-Marketing Association, Carolinas, this month at an industry banquet.

Receiving honors were a celebration for the “millionth fresh bird produced during the 2010 holiday season,” a press release announcing  330,000 pounds of turkey products donated to the needy and a campaign in partnership with the Weekly Reader that demonstrates “how responsible agricultural practices lead to healthy animals and safe, high-quality food for consumers.”

Bayer launched Yaz in 2006 as a pill that goes “beyond birth control” to treat acne and severe PMS, all the while avoiding the water retention of traditional birth control pills. But soon, previously healthy teenagers experienced “beyond birth control” effects they hadn’t expected. Fifteen-year-old Katie Ketner had her gallbladder removed after taking Yaz, Susan Gallenos had a stroke and part of her skull removed and Michelle Pfleger, 18, collapsed and died of a pulmonary thromboemboli, according to published reports.

The FDA could have held hearings into the safety of the Yaz ingredient, drospirenone, as early as 2002, instead of this month. That’s when the newsletter, Worst Pills Best Pills, warned that drospirenone, just approved in the pill Yasmin, “has never before been marketed in the US,” and could cause “serious heart and other health problems such as a change in acid balance of the blood and muscle weakness.”

But instead of investigating the drug nine years ago, the FDA decided to ban the newsletter’s editor, Sidney Wolfe, MD, head of the Public Citizen Health Research Group from voting at this month’s Yaz hearings, because the newsletter had termed the drug a “do not use.” The FDA accused Wolfe of an “intellectual conflict of interest.”

This is not the first time the FDA has silenced Wolfe. During 2010 hearings about Jazz Pharmaceuticals’ fibromyalgia drug Rekinla, Wolfe’s microphone was turned off when he asked why the manufacturer’s guilty plea and $20 million penalty for illegal marketing a different drug was never brought up at the hearings. Was it not relevant?

Jazz’s off-label marketing, “is a matter related to compliance and it’s not a matter that’s related to the topic under discussion today,” explained Bob Rappaport, MD, director of the FDA Division of Anesthesia & Analgesia Products. The only significance of bringing up the wrongdoing case would be to, “impugn the sponsor in the hopes that the committee would be punitive towards them in your deliberations and recommendations regarding this application,” said Rappaport. Why should a $20 million guilty plea affect future approvals?

Not only was the Jazz guilty plea irrelevant, the FDA did not even know about it before Wolfe’s disclosure said published reports.

Nor is this is the first time the FDA’s right hand does not know what the FDA’s left hand is doing. Just three months before a major label change for the antipyschotic drug Seroquel, Janet Woodcock, MD, head of the Center for Drug Evaluation and Research told Project on Government Oversight a warning about mixing drugs would not happen.

“At this point, there is agreement within CDER that an interaction between quetiapine [Seroquel] and methadone that confers unreasonable risks to patients is exceedingly unlikely and, therefore, no further action is indicated regarding the labeling for these products or for related communication initiatives,” she writes in a rambling, defensive letter.  But the ink was barely dry on the letter before the FDA announced that Seroquel “should be avoided” in combination with at least 12 other medicines including heart rhythm drugs, synthetic opioids like methadone, antibiotics, anti-infectives and other antipsychotics. Families’ of soldiers and others who died while taking Seroquel had said exactly that for years.

When a reporter asked about the apparent egg on the FDA’s face, Sandy Walsh, an FDA spokesperson, said Woodcock’s letter was still correct, “because the F.D.A. had found no biological basis for a problem or unusual numbers of deaths at normal dosages.” In other words, the deaths were just from drug interactions and overdoses. Whew. The decision to suspend Wolfe’s voting rights was also agreed upon by Woodcock.

Of course, the FDA’s claim that Wolfe has an “intellectual conflict of interest” reduces anyone who believes in consumer rights or governmental justice to the level of a six-digit pharma lobbyist. Holding an opinion, holding a lucrative pharma consultancy–same idea right?

In fact, FDA advisory committees are so packed with pharma consultants, its Psychopharmacologic Drugs Advisory Committee was actually chaired by a paid AstraZeneca speaker until 2009, even as it reviewed AstraZeneca drugs! The only reason AstraZeneca speaker Jorge Armenteros, MD was removed from voting and then his chairmanship  was because the Philadelphia Inquirer exposed the extreme conflict of interest. The FDA would probably call the Inquirer’s reporting an “intellectual conflict of interest.”

Well, Ambien is back with a new name for a new type of insomnia this holiday season.

Intermezzo is marketed for “middle-of-the-night” insomnia, one of many varieties of insomnia Pharma has rolled out to churn the insomnia drug market. Others are chronic, acute, transient, initial, delayed-onset, and terminal insomnia and don’t forget non-restful sleep which can co-exist with all of the above.

Of course, the only thing more lucrative to Pharma than a new variation on a disease is a new patent on an existing drug because no research and development is necessary. Remember how Prozac resurfaced as the PMS pill Sarafem? The antidepressant Effexor was tweaked into Pristiq? And most recently Neurontin resurfaced as Horizant, a treatment for restless legs (though many say Neurontin causes restless legs)?

Kennedy was not the only person to walk, drive and engage in purposeful behavior in an Ambien blackout. Law enforcement officials reported that traffic accidents increased under Ambien, with some drivers not even recognizing the police officers there to arrest them. (“Dude–where’s my car?”) Ambien’s manufacturer was forced to publish ads telling people if they were going to take Ambien, to get in bed and stay there after Kennedy’s over zealous parliamentarianism. (Or you’ll break out in handcuffs, added cynics.) The FDA issued warnings about the potential of “complex sleep-related behaviors” on Ambien and other sleeping pills which may include “sleep-driving, making phone calls and preparing and eating food (while asleep).”

In fact, it was EWI– eating while intoxicated or “preparing and eating food (while asleep)” — not DWIs that gave Ambien its worst rap. Fit and sexy people awoke amid mountains of pizza, Krispy Kreme and Häagen-Dazs cartons consumed by their evil twin, on Ambien. Weeks of dieting and treadmill time shot to hell.

The new sleeping pill also served to occlude three uncomfortable Big Pharma settlements right before Thanksgiving. Did anyone notice that Merck pled guilty to criminal marketing of the painkiller Vioxx and agreed to pay $950 million before the holiday? In addition to the $4.85 billion it has already paid to victims?

Vioxx was billed as a “super-aspirin” for everyday pain until it was removed from the market in 2004 for doubling heart attack risks and causing between 27,000 and 50,000 heart events and deaths. Merck knew the heart risks and pushed Vioxx for non-approved uses according to published reports, but no corporate executives ever went up the river. “There was no basis for a finding of high-level management participation in the violation,” Merck’s pre-Thanksgiving news release self-congratulates.

Then there’s Pfizer. The drug giant agreed to pay more than $60 million to resolve federal probes into alleged bribes to overseas doctors to use Pfizer drugs, reported the Wall Street Journal before the holiday. Penalties were probably reduced because Pfizer was willing to help the government by “ratting” on its competitors, says the Journal.

Meanwhile, the Chicago Tribune reported before Thanksgiving that Abbott is about to settle lawsuits that it illegally marketed the epilepsy drug Depakote to nursing home directors, geriatric doctors and other long-term care facilities and greased palms with kickbacks.  Abbott has set aside $1.5 billion for a settlement, says the Trib.

While the Merck, Pfizer and Abbott settlements may look sizeable, copping to a settlement allows drug companies to keep the Medicare and Medicaid reimbursement which is their lifeblood. Profits from the alleged wrongdoing usually dwarf penalties, too. “Even with these large fines, it is still good business to promote drugs illegally,” says Dr. Adriane Fugh-Berman, director of PharmedOut, a project at Georgetown University Medical Center.

The public barely noticed the million and billion dollar settlements. They were too busy eating, sleeping and maybe both.

In June, Pfizer announced it was ending arsenic-containing chicken feed which no one realized they were eating anyway but its arsenic-containing Histostat, fed to turkeys, continues. Poultry growers use inorganic arsenic, a recognized carcinogen, for “growth promotion, feed efficiency and improved pigmentation,” says the FDA. Yum.

And in August, Cargill Value Added Meats, the nation’s third-largest turkey processor, recalled 36 million pounds of ground turkey because of a salmonella outbreak, linked to one death and 107 illnesses in 31 states. Even as it closed its Springdale, Arkansas plant, steam cleaned its machinery and added “two additional anti-bacterial washes” to its processing operations, 185,000 more pounds were recalled the next month from the same plant.

Since the mad cow and Chinese melamine scandals of the mid 2000′s, a lot more people think about the food their food ate than before. But fewer people think about the drugs their food ingested. Food animal drugs seldom rate Capitol Hill hearings which is just fine with Big Pharma animals divisions since if people knew the antibiotics, heavy metals, growth promotants, vaccines, anti-parasite drugs and feed additives used on the farm, they would lose their appetite. Besides, people aren’t Animal Pharma’s primary customers anyway and the long term safety of animals drugs isn’t an issue, since patients are supposed to die.

One of the late Sen.Ted Kennedy’s last legislative fights was about the overuse of livestock antibiotics. “It seems scarcely believable that these precious medications could be fed by the ton to chickens and pigs,” he wrote in a bill called the Preservation of Antibiotics for Medical Treatment Act of 2007 (PAMTA) which has yet to pass. “These precious drugs aren’t even used to treat sick animals. They are used to fatten pigs and speed the growth of chickens. The result of this rampant overuse is clear: meat contaminated with drug-resistant bacteria sits on supermarket shelves all over America,” said Kennedy.

Because antibiotics make animals use feed more efficiently so they eat less and control disease in confinement farming’s packed conditions at the same time, they are practically the fifth food group. On a turkey farm with five million hens, antibiotics would save almost 2,000 tons of feed a year says an article in a poultry journal.

And when the FDA tried to ban cephalosporins in 2008, one type of antibiotic crucial for treating salmonella in children, it became apparent just what Kennedy was up against. Two months after the FDA announced a hearing about a cephalosporin “Order of Prohibition” in agriculture, the regulatory action had morphed into a “Hearing to Review the Advances In Animal Health Within The Livestock Industry” thanks to lobbyists from the egg, chicken, turkey, milk, pork and cattle industries.

“Order of Prohibition”… “Hearing to Review the Advances In Animal Health Within The Livestock Industry,” same idea, right?

At the House Subcommittee on Livestock, Dairy, and Poultry hearings, the National Turkey Federation’s Michael Rybolt defended antibiotics as a cost savings to consumers. “The increased costs to raise turkeys without antibiotics is real,” he said. “Today at retail outlets here in the D.C. market, a conventionally raised turkey costs $1.29 per pound. A similar whole turkey that was produced without antibiotics costs $2.29 per pound. With the average consumer purchasing a 15 pound whole turkey, that would mean there would be $15 tacked on to their grocery bill.”

Conventionally grown turkeys are even a better deal when you consider the cost of antibiotics!

And antibiotic-based turkey farming is downright green, said Rybolt, calling 227 acre turkey operations, “small family farms.” Without them, more land would be needed to grow crops and house the animals because of the “decrease in density.” And, with 175,550 more tons of feed needed, there would be “an increase in manure.”

When the FDA capitulated to industry and turned the cephalosporin prohibition into a salute to animal “advances,” former Kansas governor and former dairyman John Carlin, asked, “What changed in less than five months? Certainly the problem hasn’t gone away.”

This month, the FDA also rejected petitions to ban human antibiotics like penicillins, tetracyclines and sulfonamides in livestock filed by the Center for Science in the Public Interest, Environmental Defense, the American Academy of Pediatrics, the American Public Health Association, Food Animal Concerns Trust (FACT), and the Union of Concerned scientists, some filed over 12 years ago. Why?  “FDA cannot withdraw approval of a new animal drug until the legally-mandated process,” said an FDA spokesman. The process includes an “evidentiary hearing,” perhaps like the cephalosporin advances.

Of course. germs in turkey and other meat, even antibiotic resistant germs, are neutralized by cooking–but drug residues are not. A report last year from the USDA’s inspector general accuses U.S. slaughter houses of releasing products to the public with excessive drug levels in them and charges that, “The effects of these residues on human beings who consume such meat are a growing concern.”

Nor are the antibiotics just in the meat! Scientists at the University of Minnesota found antibiotic residues in corn, green onions and cabbage after growing them on soil fertilized with livestock manure. The drugs siphoned right up from the soil in just six weeks.

A quick look at the Code of Federal Regulations for turkey drugs does not whet you appetite for Thanksgiving. There are several arsenic turkey drugs approved to provide an, “increased rate of weight gain and improved feed efficiency,” say the official guidelines. But they are also “dangerous for ducks, geese, and dogs,” and must be discontinued,  “5 days before slaughtering animals for human consumption to allow elimination of the drug from edible tissues.” Whew.

Halofuginone, another drug given to turkeys to kill pathogens, “is toxic to fish and aquatic life” and “an irritant to eyes and skin,” says the Federal Code. “Avoid contact with skin, eyes, or clothing” and “Keep out of lakes, ponds, and streams.” Bon appetit.

Drug-based farming has cut the time to “grow” an animal almost in half while doubling the market size of the animal itself.  For example, chickens were once slaughtered at fourteen weeks, weighing two pounds and are now slaughtered at seven weeks, weighing four and six pounds.

But the brave new food techniques come at a price because the animals’ organs can not always keep up with the metabolic frenzy. Birds “fed and managed in such a way that they are growing rapidly,” are at risk of sudden death from cardiac problems and aortic rupture, say poultry scientists.

Growth drugs in turkeys may also “result in leg weakness or paralysis,” says the Federal Code, a side effect that a turkey slaughter house worker reports firsthand. Many turkeys arrive at the House of Raeford, in Raeford, NC with legs broken or dislocated, he told me in an interview and, “When you try to remove them from their crates, their legs twist completely around, limp and offering no resistance.” The turkeys, “must have been in a lot of pain,” says the worker, but they don’t cry out. “In fact the only sound as you hang them, he says, is the “trucks being washed out to go back and get a new load.”

The undercover employee’s reports of the “live hanger” culture at the House of Raeford, in which workers pulled the heads and legs off turkeys when they were stuck in crates and worse, led to Denny’s suspending its business from Raeford, the nation’s seventh largest turkey producer. The slaughter house is also infamous for a chlorine spill that killed a worker in 2003, an ammonia spill that evacuated  two towns the next year and a murdered worker in 2006.

Still, the mother of all turkey drugs is the asthma-like drug ractopamine, marketed as the “Medicated Tom Turkey Feed” Topmax. Approved for turkeys only two years ago, figures for Topmax use in turkeys are not yet available but the same drug is now used in 45 percent of U.S. pigs and 30 percent of ration-fed cattle.

There are two reasons ractopamine has raised safety questions. One is that its label reads:

WARNING: The active ingredient in Topmax, ractopamine hydrochloride, is a beta-adrenergic agonist. Individuals with cardiovascular disease should exercise special caution to avoid exposure. Not for use in humans. Keep out of the reach of children. The Topmax 9 formulation (Type A Medicated Article) poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Topmax, use protective clothing, impervious gloves, protective eye wear, and a NIOSH-approved dust mask. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse eyes thoroughly with water. If irritation persists, seek medical attention. The material safety data sheet contains more detailed occupational safety information. To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.

The other reason is that ractopamine is not withdrawn at slaughter. In fact, it is begun as the animals near slaughter and started during turkeys’ last 14 days. It is actually pumping through their systems as they arrive on the killing floor.

Like antibiotics and arsenic, ractopamine is given to turkeys to make them grow faster. It is similar to clenbuterol, a performance enhancing sports drug that is banned in the US, for both humans and livestock, and elsewhere. But ractopamine is also banned in Europe, Taiwan and China, where 1,700 ractopamine “poisonings” were reported and ractopamine-produced pork was seized in 2007. (You have to worry when China calls a food unsafe.)

Ractopamine caused actual riots in Taiwan in 2007 when 3,500 Tawainese pig farmers, some carrying pigs, threw dung and rotten eggs at police and military soldiers over the rumor that a ractopamine ban would be lifted.  “Get out, USA pork” and “We refuse to eat pork that contains poisonous ractopamine,” they chanted for hours according to Taiwan News.

Reports of ractopamine’s lack of safety are not hard to find.  In 2009, the European Food Safety Authority (EFSA) termed ractopamine a cardiac stimulator. Ractopamine residues “represent a genuine risk to consumers,” wrote a medical  journal article, citing “long plasma half-lives, and relatively slow rates of elimination.” And a report from Ottawa’s Bureau of Veterinary Drugs says that rats fed ractopamine developed a constellation of birth defects like cleft palate, protruding tongue, short limbs, missing digits, open eyelids and enlarged heart.

The FDA is well aware of ractopamine’s downside. In 2003, three years after the drug was approved for use in U.S. pigs, the FDA accused its manufacturer, Elanco, of withholding information about ractopamine’s “safety and effectiveness” and “adverse animal drug experiences” in a fourteen-page warning letter.

Elanco, said the FDA, failed to report furious pig farmers phoning the company about “dying animals,” “downer pigs,” animals “down and shaking,” “hyperactivity” and “vomiting after eating feed with Paylean,” and also suppressed clinical trial information. But, thanks to same probable lobbying that reversed the cephalosporin ban, the FDA approved ractopamine for cattle the following year and for use in turkeys in 2009! Last year, the FDA enlarged the approval for cattle.

Turkey meat produced with ractopamine is not the same as normal meat by Elanco’s own admission! “Alterations” in muscle were seen in turkeys fed ractopamine like an increase in “mononuclear cell infiltrate and myofiber degeneration,” says its 2008 new drug application documents. There was “an increase in the incidence of cysts,” and differences, some “significant,” in the weight of organs like hearts, kidneys and livers. (“Enlarged hearts” had been seen in test rats feed ractopamine in the Canadian studies.)

Still, ractopamine, like antibiotics, is being hailed as “green” and for lowering the carbon footprint. It has “positive environmental benefits for livestock producers in terms of decreased nitrogen and phosphorus excretions,” extols one journal article. It results in a “reduced amount of total animal waste,” unless, of course, you count the manure coming from Big Pharma.

Big Pharma and the FDA have known for years that formoterol fumarate, found in Symbicort, Dulera and Foradil, and salmeterol, found in Advair Diskus and Serevent Diskus, can paradoxically cause asthma deaths, especially in children and African-Americans. In fact, the FDA has heightened the warnings on the labels several times and convened several hearings about the drugs’ safety and some doctors have called for their complete ban.

But the drugs, called long acting beta agonists, or LABAs, are so lucrative — Advair was the fourth best selling drug in the US last year, making almost $5 billion — they are marketed despite their estimated US death toll of 4,000 a year. That’s equal to, or even more than, the number who die from asthma itself!

LABAs, whose aggressive marketing coincided with direct-to-consumer drug advertising, are billed as add-on drugs that treat asthma in a different way than traditional steroid asthma drugs. Traditional, inhaled corticosteriods like Flovent, Pulmicort, Asmanex and Qvar treat asthma’s inflammation, while LABAs, prescribed as maintenance or “control” drugs, expand constricted airways and protect against bronchospasm.

But study after study show the “bronchoprotective” effects have a downside. They can “mask” asthma that is actually getting worse though people feel fine, and they can produce “desensitization” or “down regulation” also known as tolerance, in which the more you use them the less they work.

In fact, Salmeterol, the drug in Advair and Serevent, is considered so unsafe, a huge trial called the Salmeterol Multi-center Asthma Research Trial, or SMART was terminated in 2003 after there were 16 deaths, 44 intubations and 369 hospitalizations on LABAs, mostly in African-Americans.

At FDA hearings after SMART, Pharma doctors tried to spin the results by saying the patients had been sicker to begin with, that they were too slow to seek medical care and that their self-reports of LABA use couldn’t be trusted because patients lie. They also said (somewhat contradictorily) that LABAs don’t mask worsening asthma because patients know if they are getting worse (not that they get worse!) — and the deaths can be explained by patients’ DNA types. Whew.

LABA defenders even said the SMART results couldn’t be trusted because the trial was stopped early.

Usually, the justification for unsafe drugs like LABAs is that their benefits outweigh their risk. But at FDA hearings three years later, David Graham, MD, an FDA official, said LABA “benefits, if any, seemed to be small compared to placebo.” He also blew the whistle on the widespread Pharma myth that a decline in US asthma deaths over the last decade is due to LABAs.

“It is true that trend for reported asthma deaths has declined over time, ” he said in the hearings. “But nobody has shown that the decline has anything to do with LABA use.” Fifty percent of the decline “is due to the change in classification coding from IC-9 to ICD-10,” said Graham, known for testifying before Congress about Vioxx dangers.

While the number of asthma deaths is down, the number of asthma sufferers is growing — and no one really knows why. Some cite more pollens in the air from global warming, an excess of allergy causing plug-in air fresheners and the “hygiene theory” that we have created such a germ and dirt free environment, our immune systems can’t differentiate real threats from harmless pollens or dust.

Others cite burgeoning prescription drug use. Researchers at Henry Ford Hospital found children given antibiotics within their first six months of life were more likely to develop allergies. Data presented at the American Academy of Allergy, Asthma & Immunology suggest children whose mothers took prescription acid-blocking drugs like Nexium during pregnancy are more likely to suffer symptoms of asthma. And research in the American Journal of Respiratory and Critical Care Medicine found that Tylenol may be, “an important risk factor for the development and/or maintenance of asthma, rhinoconjunctivitis and eczema in adolescent children.” Meanwhile, a 1999 European Union report speculates about the role of sex hormones and meat additives in asthma.

To prove that LABAs are safe and effective, Pharma not only points to falling US asthma deaths rates, it points to LABAs’ inclusion in government asthma guidelines Even though Pharma doctors virtually wrote the government guidelines!

William W. Busse, MD, from the University of Wisconsin School of Medicine and Public Health, chaired the expert panel which developed the government’s 2007 National Asthma Education and Prevention Program Guidelines — even though he is financially linked to GlaxoSmithKline, Merck, Novartis, Pfizer Genentech/Novartis, Schering and five other Pharma companies according to the guidelines themselves.

No wonder federal guidelines extol the “established beneficial effects of LABA for the great majority of patients who require more therapy than low-dose ICS alone to control asthma,” and call LABAs a “preferred option” that “improves lung function, decreases symptoms [and] reduces exacerbations!” Not that we have an opinion.

Why is a Pharma doctor writing federal disease treatment guidelines? And why, on top of 10 Pharma backers, does he have “research support from the NIH” which is our tax-dollars? Aren’t enough tax dollars buying Medicare and Medicaid-reimbursed LABAs thanks to the “guidelines”?

Since SMART and more reported deaths, the FDA has continued to hold hearings and tighten warnings. Currently, warnings say LABAs should only be used when inhaled corticosteriods don’t control asthma, and for the shortest time possible and should notbe used without corticosteriods or as a “rescue” medication.

Needless to say, if LABAs have to be used in addition to inhaled corticosteriods and in addition to rescue inhalers (like Proventil HFA, ProAir HFA, Ventolin HFA) what they are actually good for is not clear — even as Pharma sells a third, possibly surplus drug. No wonder Forbes magazine calls the LABA-containing Advair, “more a miracle of marketing than of science.” Many also question whether the addition of an inhaled corticosteroid, which Symbicort, Dulera and Advair have, even makes them safer.

Of course, LABA promoters are furious about the warning that LABAs should not be used long term. “Suddenly stopping medication that is providing a protection for individuals — without good literature experience to back it up — is something we’re very concerned about,” said William Busse at an asthma conference. And when the FDA announced this year it will retest LABAs, Busse cowrote an angry letter to the New England Journal of Medicine. New trials are unnecessary he said and calling them “‘safety’ studies suggests that LABAs have some direct toxicity that causes death or leads to hospitalization.”

Some people love LABAs and claim their asthma symptoms have gone away. But the longer they use them, the more likely they are to report Advair or Symbicort “poop-out” (like “Prozac poop-out”) in which the drug stops working and they feel worse than before.

On the drug-rating web site askapatient.com, patients also report feeling “addicted” to the drugs and that their lung capacity is changing. “My lungs feel different than normal, like my lungs are feeling dried out and sticky if that is possible, all at the same time, reports one person about Symbicort. “It seems they are becoming lazy, like now they cannot miss a dose.”

“When I sucked it in, it felt like I was collapsing my lungs,” says an Advair user in Forbes. The man’s doctor told him the drug “couldn’t possibly be making him worse,” but it was.

Twenty-five patients on Advair Diskus 100/50 also report racing and irregular heart beats, palpitations and the feeling of an imminent heart attack.

LABAs are not the only asthma drugs with questionable safety and effectiveness that have become billion dollar businesses for Pharma. Singulair, a leukotriene receptor antagonist or LTRA, was the nation’s seventh most popular drug last year, according to IMS health and earned more than $4 billion.It ranks only two places below Advair. Other LTRAs are Accolate and Zyflo.

Soon after Singulair was released to the market, FDA reviewers cautioned in the New England Journal of Medicine that adult studies of the drug “may not be predictive of the response,” in children. No kidding! In Singulair’s FDA approval documents reviewers note that Singulair levels in adolescents are different from “healthy adults” and that an infant monkey, four weeks old, had to be euthanized because “infants may be more sensitive to the toxicity,” of Singulair. (“Three out of five guinea pigs also died from “severe anaphylactic responses.” If animal tests do not extrapolate to human safety, why are they done?)

Scores of human subjects in the FDA approval documents withdrew from trials because of “worsening” asthma and reviewers even write that one study, “demonstrates that it is better to leave patients on beclomethasone [a corticosteroid] than to switch them to montelukast [Singulair]. There’s an asthma drug for you!

Approval documents include 10 blanked out pages, marked “This section was determined NOT to be releasable,” and the frequent phrase, “Portions of this review were excerpted directly from the sponsor’s submission,” as in we didn’t read it but we waved it through.

William Busse, the guidelines writer, was also an investigator in the Singulair approval trials though not the most compliant one. He was issued an FDA warning letter when an inspection of his facility revealed incorrect consent forms, incorrect patient enrollments, and drug inventory and labeling errors.

Singulair was heavily marketed for allergies, in addition to asthma, and to kids. Marketing included a partnership with Olympic gold-medalist swimmer Peter Vanderkaay, a basketball “skills challenge” for kids 9 to 14 and materials distributed through (and legitimized by)American Academy of Pediatrics said published reports.

Meanwhile, more than 100 parents on askapatient were reporting that Singulair caused hyperactivity, tantrums, depression, crying, school trouble, facial tics, strange eye movements and self-harm in their children, some as young as one. Many were put on the drug for sniffles, wheezing and early “symptoms” of asthma, in keeping with Pharma’s “early treatment” push.

“Last night was a complete meltdown over every single thing that could have possibly been a minor annoyance, such as not being able to squeeze enough toothpaste out of the tube, which culminated in a 30-minute screaming and crying bonanza,” writes the mother of a 7-year-old who has been on Singulair for six months. “I was reading stories to her tonight, and she must have popped her jaw open at least 40 times over the course of two books (mouth open wide like a yawn in fast-forward). I was keeping an eye on her, and a few times I asked her why she kept doing that and she said she didn’t know, and she thought maybe her mouth was ‘itchy.’”

But in 2009, after 15-year-old Cody Miller of Queensbury, NY was given Singulair for hay fever and took his own life 17 days later, the FDA gave Singulair a warning for “neuropsychiatric” side effects. And the next year, Fox TV reported that kids on Singulair are being diagnosed with ADHD, Tourette Syndrome and serious behavioral and neurological conditions. Most are “cured” when they go off the drug. Singulair is no doubt driving other pediatric drugs sales.

Even adults are put on the drug for minor reasons with major consequences. “I was perfectly healthy prior to taking this drug,” reports a 53-year-old woman about Singulair on askapatient.”Doc noticed I had a little wheeze and prescribed Singulair. I began to have the dreams, insomnia and depression after the first few days,” which led to “suicidal thoughts,” she says.

Could there be any more clouds over today’s blockbuster asthma drugs? Yes! Clinical trials on which many of the top asthma drugs were approved were so corrupted at least one researcher went to prison. William H. Ziering, MD was sentenced to six months in prison and lost his medical license for falsification of five drug studies according to government documents.

Ziering conducted trials on Salmeterol (the LABA), Flonase and other respiratory drugs and wrote medication-friendly papers like “Allergic rhinitis. Measures to control the misery,” and “Diagnosis and treatment of allergic rhinitis and asthma in infancy and childhood.”

During the same time period, clinical trials of Singulair and at least five other top asthma drugs conducted at Vivra Asthma & Allergy also came to the attention of federal authorities. A “patient mill” was operated at the Tucson facility to pocket the lucrative compensation paid per subject for trials, says Robert Davidson, MD, a sub-investigator at the facility, regardless of the appropriateness of the subjects. People who participate in drug trials are called subjects, not patients

The irregularities at the Vivra facility led to onsite FDA inspections in which witnesses told inspectors they were told to “NOT mention potential risks” to subjects to not “scare them away,” and subjects were pressured to participate despite risks to their heath. (One subject was hospitalized from the trials.) Enrolling inappropriate subjects risks both their health and future users of the drug, whose safety was “proved” from their participation.

In one study, conducted at Vivra and elsewhere, more than 40 percent of people on Singulair and Salmeterol (the LABA in Advair) had adverse events, two withdrew with –anybody? — “worsening asthma” and “one died as a result of bronchial asthma!” The drugs were “well tolerated,” write the researchers.

There is no evidence that approval of drugs “tested” by Vivra or Ziering was delayed or revoked nor do the related published papers appear retracted.

Among drugs tested at Vivra was the antibiotic Raxar® which was withdrawn from the market for fatal heart rhythm abnormalities and the genetically engineered Xolair which was investigated by the FDA for heart attack and stroke links and carries a severe anaphylaxis warning. Seventy-seven people who took Xolair had life-threatening allergic responses in a year-and-a-half, according to FDA reports.

Genetically engineered drugs like Xolair cost as much as $20,000 a year and cause TB, cancers and super infections because they suppress the immune system. But they seem slated to be the next big thing in asthma.

A study in May says Xolair can provide, “additional clinical benefit” for patients who are “inadequately controlled” on inhaled corticosteroids. That’s exactly what was said about LABAs. The study was funded by Xolair’s manufacturer and one of the authors is William Busse.

Last year, Hefner attended the premier of a film commemorating his life called Hugh Hefner: Playboy, Activist and Rebel at the Gene Siskel Film Center, part of Chicago’s Art Institute. Looking more like a seasoned Maurice Chevalier or elder statesman than Bathrobe Erectus, Hefner received a standing ovation.

The movie, directed by Brigitte Berman, is one of several recent films to chronicle Chicago history. Last year the center screened Disturbing the Universe about Chicago 8 lawyer extraordinaire William Kunstler. The year before, the film center premiered Radical Disciple: The Story of Father Pfleger, which had David Axelrod, Chicago’s second most famous son (after President Obama) in attendance.

Anyone who grew up before Reagan, in Chicago or both enjoyed the forgotten cultural icons that director Brigitte Berman revives in the film: Dick Gregory, Lenny Bruce, Miles Davis, Dizzy Gillespie, Count Basie, Louis Armstrong, Sammy Davis Jr., William F. Buckley, Dick Cavett, David Steinberg and many more.

TV clips from hifi, party record and hootenanny days from the TV shows Playboy’s Penthouse and Playboy After Dark feature folk singers Pete Seeger and Joan Baez and rare performances.

Who knew, until the film, that Playboy sponsored one of the biggest jazz festivals in history? Who knew it sent the Playboy jet to retrieve Vietnam orphans who were nursed back to health by bunnies (out of costume)? Who knew Playboy supported Children of the Night, a group that helps runaways evade prostitution?

But halfway through the movie, a creep factor sets in. Maybe, it was the parade of so many talking heads who have died since the film was made–Alex Haley, Robert Culp, Tony Curtis–or the fact that Hef wannabe Penthouse publisher Bob Guccione died right before the film was shown.

Maybe it was the ubiquity of Kiss’ Gene Simmons who is so sexually and psychiatrically unbalanced that he told NPR’s Terry Gross to “open your legs” in an interview–or the appearance of a leering James Caan who was linked to Hollywood prostitute broker Heidi Fleiss. (At the film’s end, Simmons who, pontificates about male sexual parts being aroused by clothing while women’s are hidden away (what?) removes the sunglasses he’s been wearing through all the film in a repulsive gesture of grandiosity and apparent exhibitionism.)

Still the straw dog enemies of lust that director Berman sets up in the film–Pat Boone, Jerry Falwell, Charles Keating–are not nearly as creepy as those who are supporters of Hefner’s brand of lust.

What, for example, is the Rev. Malcolm Boyd, author of Are You Running With Me Jesus, doing at an establishment where half the sky, as Nicholas Kristof puts it, is deemed worthy of wearing animal tails? Where have Hefner supporters Dick Cavett and David Steinberg been for the last 30 years to not notice that Oprah, Chelsea Handler and the women on the View have retired them? And what is up with Bill Maher’s appearance?

In fact, the pride that Hefner says he feels for “liberating” the segregated New Orleans Playboy Club so that African-American men could enjoy “cottontail” service produces a sense of incredulity in women viewers. It brings to mind a scene in Sacha Baron Cohen Bruno in which Cohen invites the singer Paula Abdul, who has arrived for an interview, to use a Mexican gardener on his hands and knees as a chair–and she does! Hefner’s fight against “oppression” and “sexual McCarthyism,” that the film exalts is like the Bruno scene–everything is fine if you ignore the furniture.

An admitted sex, Dexedrine, Pepsi and work addict, Hefner has the constellation of self-centeredness and resentments often called King Baby. He says he “deserved” seven girlfriends because he had been monogamous for eight years before that. He says the death of playmate Dorothy Stratten, who was murdered by her husband, Paul Snider, months after she was named the 1980 Playmate of the Year, gave him his stroke and that it was a “miracle,” he got through it. (Let’s talk about ME.) And he says the suicide of his former secretary, Bobbie Arnstein, who was found dead in a Chicago hotel room after an overdose of drugs in January 1975, was caused by drug officials and hurt the Playboy brand and image.

Hefner is admired for his business acumen yet he’s clueless about why the magazine tanked by the late 2000′s. He actually blames Former Attorney General, under Ronald Reagan, Edwin Meese for labeling the magazine obscene, not the laddie magazines and cyber porn that carved away his market. Hefner took the brand hard core in 2001 over the objections of daughter Christie, CEO of Playboy Enterprises, who told the Daily Telegraph as a “feminist” she would not take the magazine hard core.

Of course the half the sky who became doctors, judges, senators, astronauts, scientists, House Speakers, Secretaries of State and magazine publishers also helped retire the Playboy brand along and a backlash against commodification capitalism and mindless consumerism.

In fact, when asked flat out about Playboy treating women as sexual objects–animals with tails attached–Hefner still stands by the brand and says it is because they are. Hugh Hefner: Playboy, Activist and Rebel confirms that Playboy is a just a White Boy’s Club that decided to let men from other races in.

One reason for the switch away from pills is that doctors are increasingly wary of prescribing new “blockbuster” drugs after the recalls of Vioxx, Bextra, Baycol, Meridia, Trovan, Fen Phen and new warnings on asthma, epilepsy, pain, bone and hormone drugs.

And there are new wrinkles in compensation. Private and government insurers are becoming less willing to “cough up money for an expensive new drug–particularly when a cheap and reliable generic is available,” the Wall Street Journal reported recently.

So it’s no wonder that Pharma and its benefactors at the National Institutes of Health are mining a new revenue source: the nation’s millions of alcoholics and drugs addicts who need a “vaccine.”

“Sixty percent of people with a substance abuse disorder also suffer from another form of mental illness, says a recent New York Times’ Science Times. (Another?) They are “wired differently” and may have a “developmental brain disorder,” says the article, next to a photo of Amy Winehouse, lest anyone miss The Point.

“We now know that addiction is a disease that affects both brain and behavior,” says Nora D. Volkow, director of the National Institute on Drug Abuse, in an National Institutes of Health newsletter. “We have identified many of the biological and environmental factors and are beginning to search for the genetic variations that contribute to the development and progression of the disease.”

Of course, Pharma’s stratagems to grow its “mentally ill” franchise are well known. People with occasional anxiety are really depressed, then bipolar, then suffering from an assortment of amorphous “spectrum” diseases and dysrythmias with no known cause, no cure, no diagnostic tests and no turnoff valve on the pharmacy spigot.

The situation is even worse for children because they’re given drugs against their will by parents, teachers and doctors. Toddlers are diagnosed with ADHD, conduct disorders, depression, bipolar disorder, oppositional defiant disorder, mood disorders, obsessive-compulsive disorders, mixed manias, social phobia, anxiety, sleep disorders, borderline disorders, irritability, aggression, pervasive development disorders, personality disorders and (pant, pant) even schizophrenia–all of which require expensive medication cocktails.

But the picture gets scarier when researchers start identifying “biological factors” in “animal models” of addiction and depression at major primate research centers.  (There are eight including the University of Washington, Seattle; the University of California, Davis; the University of Wisconsin, Madison; Emory University; Harvard University; the Southwest Foundation for Biomedical Research; Oregon Health Sciences University; and Tulane University.)

Scarier for people that is. It’s already pretty scary for animals.

Because even though “proof” of mental illness in animal and human brain matter is as accurate as phrenology, it allows Brave New World diagnoses in which people suffer from – or are at risk of -psychiatric illness in the absence of symptoms. On the basis of a brain scan!  Because we have a drug to treat it.

Already drugs for pre-asthma, pre-diabetes, pre-mental illness, pre-cardiovascular conditions and pre-osteoporosis are a big part of Pharma’s arsenal. (And bone measuring machines that “prove” risk for osteoporosis, are in doctors’ offices.)

Pharma’s “early treatment” ruse — especially insidious in children who aren’t given the chance to grow up without drugs — is accelerated by disinformation that the mongered “silent” diseases are progressive: the longer you wait to treat them, the sicker you get! But who knows whether the drugs were ever needed, since they’re taken before symptoms appear?

Of course, the first problem with Pharma’s plan to treat alcoholic and drug addicts’ mental illness with a vaccine is that they are not mentally ill or suffering from a vaccine deficiency. But, secondly, alcoholism and drug addiction are diseases of denial in which sufferers want to drink. Hello? (Can anyone imagine Amy Winehouse asking for a vaccine?) That’s why Antabuse, a drug that makes people violently sick if they drink on it, fails.

Thirdly, doctors have long recognized that alcoholism and drug addiction are not strictly medical problems that can be treated by practitioners. “If a doctor is honest with himself, he must sometimes feel his own inadequacy. Although he gives all that is in him, it often is not enough,” wrote William D. Silkworth, MD, in 1939. “We physicians must admit we have made little impression upon the problem as a whole. Many types do not respond to the ordinary psychological approach.”

The only treatment that works for alcoholics and addicts — much to Pharma’s chagrin — is non-medical, non-pharmaceutical and free — administered in self-help groups run by other alcoholics and addicts. Which brings us to the fourth reason Pharma can’t cash in on its new chosen customers: for alcoholics and addicts, drugs are not the solution they are the problem!

So many car commuters have converted to bus and train commuters, cities are reporting an 8 to 34 percent rise in public transit usage.

In Mayor Rahm Emanuel’s town, Chicago, the transit system is good enough that you can get away with not owning a car like in New York City. Not only can you get to both airports for $2.25, you will get there quicker and save $30.00 or $40.00.

But even though most Chicagoans will take public transit to Cubs and Sox games, Navy Pier, Taste of Chicago, and Lolapalooza, when it comes to work they are pretty Angeleno and tend to buckle up for the ride.

During blizzards like the one we had on Groundhog’s day, the amount of people who own cars they don’t regularly use was revealed dramatically. Car “carcasses” were dug out weeks later in a meteorological version of the barfly whine, “I can’t find my car.”

But as gas prices sky rocket in Chicago, parking lots are emptying say attendants and strap hanging appears to be up.

Of course getting people out of their cars and onto the train has always been a tough psychological sell say transit activists. Even if driving costs more, even if you float in a sea of brake lights as train whiz by and actually beat you to work, there’s the convenience of leaving when you want, sitting down and controlling your own environment. (And who you sit next to.)

Driving is regarded as a “right” and gives people a feeling of control even as they move nowhere and burn their equity position. Many say the worst part of a DWI conviction is losing driving privileges and being towed can cause a well adjusted person to panic.

Nor do people even want to share. Car pools fall apart because people don’t trust the “other guy’s” driving. And in car share programs where you only use the car as needed, people don’t trust the wear and tear the other guy puts on the car or whether he is maintaining it.

But of course the paradox of city driving is you’re “in control” of your car but out of control of everything else: road congestion, weather, parking, other motorists, accidents and of course gas prices.

So it’s no surprise that some who have surrendered the wheel to the bus or train operator find it sweet. In addition to some reading, music or quiet time, they don’t arrive at work splenetic at the guy who cut them off. (Nor does the guy they would have cut off arrive steaming.) One recent train convert reports the conductor saw him coming and actually held the train for him. When has that ever happened — a car waiting for someone else — in rush hour traffic?

What began as “something deeply personal and private” in their lives has become their call for social justice, awareness, and “protecting the health and safety of our loved ones,” say Debbie Alsberge of Seattle and Robin Briggs of Charlotte, NC.

Adverse reactions to Neurontin have been greatly underestimated and unreported Debbie Alsberge says she believes, harming unsuspecting families and their physicians. “We must have the full and accurate facts about a drug’s risks to make good decisions when family members consider treatment, especially with psychoactive drugs. We cannot do that if pharmaceutical companies are allowed to taint the outcome of clinical trials and bury the harmful evidence.”

Growing up in northern California, the son of a surgeon, Dr. Doug Alsberge practiced occupational medicine near Seattle. A devoted father of two sons, he enjoyed hiking,  sailing, swimming, and golf. He also liked to write and play his acoustic guitar, says Debbie.

But when back pain from a pre-existing condition began to interfere with being able to stand for prolonged periods at work, Doug sought treatment from a pain specialist he sent his own patients to, says Debbie. The doctor gave him a narcotic analgesic and the recently approved Neurontin which was heavily marketed for pain, though only FDA approved for use in epilepsy. “There was nothing in the medical literature to alert his physicians that it might not be effective, or worse, cause further harm,” says Debbie.

Though off the narcotics, Doug’s entire demeanor continued to change on Neurontin. He was agitated, couldn’t concentrate, couldn’t sleep and had tremors says Debbie. The Alsberges attributed the symptoms to Doug’s bipolar disorder, diagnosed in the 1990′s. But whereas it had always stabilized with treatment before, this time, Doug went into a psychological free fall which began to affect his ability to work. His appearance degenerated, he stopped eating normally and police had to be called to the house for his emotional volatility.

“We didn’t know his extreme internal restlessness was akathesia, which is linked to suicide in medical journals, or that it was from Neurontin,” says Debbie. In his last, dark days, Doug drove for miles “searching for a knife to end his life,”  buying one at a nearby hardware store and another at a culinary store hours away. On Palm Sunday, April 13, 2003, in an apartment he had rented away from his family, Doug died of multiple, self-inflicted stab wounds to the chest. He was 52.

The death was “surreal, bizarre and horrific,” says Debbie. But it was only when she saw an article about Neurontin suicide links that she requested Doug’s pharmacy records and realized the increases in drug dosages correlated with his symptoms and personality change says Debbie. “I just stood there in the parking lot outside of the pharmacy holding the documents in stunned disbelief,” she remembers.

Dr. Douglas Briggs was a Princeton graduate who practiced family medicine near Charlotte, NC.  Dedicated to his patients, wife and two sons, he also coached soccer, headed the PTA, played tennis and ran in what sounds like a storybook existence. Nor did Briggs ever visit a psychiatrist or mental health professional.

But after back surgery, Briggs was also put on Neurontin for the pain it was widely marketed to treat. “Medicine had been Doug’s passion and his whole life” says his wife, Robin, a former nurse. “But after a few months on Neurontin, his bedside manner became curt. He stopped reading his journals and just lay on the couch. He had always been a stoic and he became whiny about his back ache. We had never fought and we began fighting. He became a different person.”

Doug was a conservative prescriber and grilled his Pfizer rep about Neurontin’s safety more than once, says Robin. He was so attuned to his responses to medications, when he took Vioxx before its dangers were known, he noted heart palpitations — and discontinued its use. A week later, Vioxx was pulled from pharmacy shelves for causing heart problems in some patients. But thanks to Neurontin-caused akathesia, Doug’s ability to detect his own mental changes on the drug disappeared. “He did not know his suicidal thoughts were drug-induced and not his own,” she says.

On Christmas day, 2004, after opening presents, Doug urged Robin and the boys to go to a movie. Hesitant to separate on a holiday at first, Robin says she remembered an Oprah show about how men should get the chance to be alone in the house, to unwind,  like women have, so the three went see Meet the Fockers. When they returned, they found Doug hanging in the foyer. He had been on Neurontin for 10 months. He was 54.

Like Debbie Alsberge, Robin Briggs’s “aha” moment came later. Two weeks after Doug’s funeral, a distraught patient literally drove up on the Briggs’ lawn saying he couldn’t accept the uncharacteristic suicide and demanded to know what antidepressant Dr. Briggs was on, says Robin. Even though she had been asked the question countless times, responding, “He wasn’t on an antidepressant, he just took Neurontin,” this time Robin says a light bulb went off in her head and she ran upstairs to the medicine cabinet to read the Neurontin patient information for the first time.

It did not list suicide as a side effect but it did list “emotional lability” recounts Robin. “So I called my sister who is a nurse and asked her to look up Neurontin in the nurse’s desk reference. In bold letters it said ‘suicidal tendencies, sudden unexplained deaths and psychoses.’ I was sickened. Pfizer deliberately hid the risk from patients and doctors!”

The faith that Drs. Alsberge and Briggs and their doctors had in Neurontin for non-epilepsy indications didn’t just happen. It was the goal of a web of paid doctor lectures and peer selling, planted journal articles, phony medical education and rep visits to doctors that Pfizer (previously Parke-Davis and Warner-Lambert) conducted for years.

But even though Pfizer pled guilty to criminal marketing of Neurontin in 2004 and was found guilty again in 2010, it earned  $387 million from the drug in 2008. Who says crime doesn’t pay?

In just three years, Parke-Davis planted 13 ghostwritten articles in medical journals promoting off-label uses for Neurontin including a supplement to the prestigious Cleveland Clinic Journal of Medicine which Parke-Davis made into 43,000 reprints to mail to the journal’s “psychiatry audience” and to hand out by door-to-door sales reps. (“See, Doc — it says right here…”)

Even Scott Reuben, MD of Baystate Medical Center, termed the Bernie Madoff of medicine because he never conducted any of the clinical trials on which his conclusions were based, stumped for Neurontin. “Gabapentin would seem to be the ideal analgesic for managing acute and chronic pain following breast cancer surgery,” effused the researcher who was a paid member of Pfizer’s speakers bureau and recipient of five Pfizer grants in five years. In 2010, Reuben was sentenced in Federal Court to six months imprisonment.

In fact, the US Cochrane Group, which reviews health care interventions, is the only organization to retract phony Neurontin studies. The other studies still stand like legitimate medical literature, are still cited and no doubt fuel the continuing off-label sales.

After being presented with evidence of hundreds of Neurontin-linked suicides in 2005, the FDA added warnings to all epilepsy drugs in 2008. But not before Dr. Robert Temple, FDA’s Associate Director for Medical Policy for the Center for Drug Evaluation and Research, both legitimized Neurontin’s off-label uses and blamed patients, not the drug, for suicides.

Referring to Neurontin’s popular pain, migraine, insomnia and bipolar uses without mentioning their lack of FDA approval, he told the Boston Globe, “These are the sorts of people who are complicated to think about because they tend to be at risk already.” Adverse event reports “can’t really tell you whether the suicidal event is because of the drug or despite the drug,” he added.

Meanwhile Debbie Alsberge and Robin Briggs, who both have a son in medical school, don’t want to see the tragedy of drug-induced suicides continue.

“Suicide has always been looked at as a choice, but for many people on psychoactive drugs, it’s a chemical path they are on and not a choice at all” says Robin Briggs. “My husband would be alive today if this information were available and not hidden.”

“Suicide is deeply stigmatizing and devastating. But when families stay silent, we cede power to corporations that put profit ahead of human lives and we become part of the problem,” says Debbie Alsberge. “In sharing my story of what happened to Doug, I take comfort in knowing this may help others to recognize the adverse effects of Neurontin and prevent the deaths of their loved ones. I urge other families to stand up, tell their stories and be counted.”

But rather than a safer product, clearer warnings or regulatory distance between federal officials and the industry they are supposed to oversee, tuna fish consumers have gotten nothing but more studies.

Last year Time magazine reported 100 samples of both lean red tuna and fatty tuna from 54 restaurants and 15 supermarkets in Colorado, New Jersey and New York, exceed recommended amounts of mercury.

And this year Consumer Reports says every tuna sample tested at an outside lab “contained measurable levels of mercury, ranging from 0.018 to 0.774 parts per million. The Food and Drug Administration can take legal action to pull products containing 1 ppm or more from the market. (It never has, according to an FDA spokesman.)”

In fact, mercury-filled tuna is so rampant in the food supply, it was what inspired Fischer Stevens to make the Oscar winning-documentary about the Japanese dolphin fishing industry, “The Cove”.  He personally came down with mercury poisoning, he told NBCLA, after eating tuna three or four times a week which caused him to investigate the entire seafood industry.

Nor is much of the meat necessarily safe. Even though you can cook pathogens like E. coli, salmonella, listeria and campylobacter out, veterinary drugs, pesticides and heavy metals like copper and arsenic remain after cooking says a government report.

According to a 2010 Office of Inspector General report, of 23 pesticides designated by the EPA and FDA as high risk, the Department of Agriculture’s Food Safety and Inspection Service only tests for one. Four carcasses contaminated with “violative levels of veterinary drugs” were released onto the public dinner plate in just six months, says the report.

Farmers are prohibited from selling milk for human consumption from cows that have been medicated with antibiotics (as well as other drugs) until the withdrawal period is over; so instead of just disposing of this tainted milk, producers feed it to their calves,” says the report, sounding more like an animal activist group than the U.S. government. “When the calves are slaughtered, the drug residue from the feed or milk remains in their meat, which is then sold to consumers.”

FDA records corroborate the OIM report, finding that Templeton Feed & Grain and Darr Feedlots recently sold antibiotic-tainted animal feed and that Land Dairy and Martin Feed Lot sold cows with the antibiotic sulfamethazine in their livers to be sold as human food.

And while consumers are told to cook meat thoroughly to remove pathogens that are eliminated by intense heat, cooking has a downside. Frying, broiling and grilling beef, pork, poultry and even fish can produce cancer causing compounds from dripping fat called heterocyclic amines and polycyclic aromatic hydrocarbons says the National Cancer Institute. They are linked to stomach, colon, bladder and several other cancers and are to be avoided.

And processed foods like luncheon meat, ham and hot dogs? They are pre-treated with nitrites to kill food-borne germs and maintain a “natural” color like the natural “color” of mass farmed salmon. Nitrites become nitrosamines which are well known carcinogens. They are as good for you as cigarettes.

Once again Big Food is “appalled” by the video — which shows sick and injured calves killed with hammers, workers standing on calves’ necks and barely alive calves on “dead piles” — while working to make publicizing such videos illegal.

And once again farm owners blame employees and play innocent, while video clearly shows them sanctioning the violence and verifying that the suffering crossbreed calves depicted should get no medical care.

Like most factory farm owners whose operations have been investigated by Mercy For Animals, Kirt Espenson, owner of the 10,000 calf E-6 Cattle Company in Hart, TX, both denies condoning the abuse and defends it.

The animals denied medical care for their open sores, swollen joints and severed hooves are actually E-6 Cattle Company’s wholesome meat initiative he says: they were not given medicine so that people wouldn’t get drug residues! (And the ones not going to be eaten by people are given drug$? Right!)

Many others were sick from the cold weather and had to be eliminated, says Espenson — as if cold weather were an untreatable disease and sentient mammals are a walnut crop.

While Big Food, law enforcement officials and government regulators continue to view videos like E-6 as isolated events, no farm that Mercy For Animals has investigated has lacked such atrocities. From the DeCoster egg farms, finally investigated by Congress, to the Hy-Line Hatchery in Spencer, Iowa where newborn male chicks are ground up alive, to the Conklin Dairy Farms in Plain City, Ohio where cows are stabbed with pitchforks, Mercy For Animals continues to show that abuse is the order of the day when animals are nothing but economic units.

Nor do perpetrators pay. No charges were filed against the Conklin Dairy owner, Gary Conklin, for example, because “in context, Mr. Conklin’s actions were entirely appropriate,” said Union County prosecuting attorney David Phillips.

While condemning animal cruelty depicted in videos like this week’s and stressing that welfare guidelines exist, Big Food is also currently trying to make such videos, shot by undercover employees, illegal. After the E-6 video broke, June delivery for live cattle at the Chicago Mercantile exchange fell to $1.15 per pound, down over one percent. That’s real money.

The video.

All you knew about prescription drugs were creepy ads in a JAMA at the doctor’s office with a lot of fine print. Even if you knew the name of a drug, you’d never ask your doctor for it because that would be self-diagnosing and cheeky for a patient.

Flash forward to the late 1990s when direct-to-consumer (DTC) drug advertising, drug Web sites and online drug sales came on board, and self-diagnosing and demanding pills has become medicine-as-usual for many doctors and patients.

The DTC/Web perfect storm didn’t just sell drugs like Claritin, Prozac and the Purple Pill, it sold the diseases to go with them like seasonal allergies, GERD and depression. It sold risk of diseases like heart events for which you’d take a statin like Lipitor, osteoporosis for which you’d take a bone drug like Boniva and asthma attacks for which you’d use a second asthma drug like Advair. Of course, by the very definition of prevention, you didn’t know if the drugs were working but you weren’t paying out of pocket anyway so what the hay…

Thanks to DTC advertising, people started taking seizure drugs like Topamax and Lyrica for everyday pain or headaches and antipsychotics — hello? — for everyday blues or mood problems. They started taking monoclonal antibodies made from genetically engineered hamster cells like Humira that invite cancer, superinfections and TB when they didn’t have to. And FDA mandated risk disclosures — brain bleeds, sudden death, difficulty breathing, stomach bleeding, liver failure, kidney failure, muscle breakdown, fainting, hallucinations — perversely sold the drugs more either because ad frequency itself sells or because people like the identity in having a disease, like chemically experimenting on themselves or like taking a dare.

Soon anxiety graduated to depression which graduated to bipolar disorder. Children got schizophrenia and depression like adults and adults got ADHD like kids. And it didn’t stop there. If the depression you or your kid had didn’t go away — maybe because it wasn’t depression in the first place but a thing called “life” — you needed to add a drug like Abilify or Seroquel on to the original drug(s) because your depression was “treatment resistant.”

Of course if people were paying for the drugs out of their pocket and you told them to add a drug that costs almost $500 a month because the first one isn’t working, they would say the only thing “treatment resistant” is your sales pitch — go find another sucker. But if third party payers get stuck with the bill, no one seems to mind pharma’s double-(and triple)-its-money plan — or even notice it.

In fact psychiatric drug cocktails of eight, ten and twelve drugs are now common medical practice for “treatment resistant” depression and PTSD (often paid by government entitlement health plans) even though the drugs have never been tested when taken together. Unless you count the patients taking them now!

Pharma also adds an urgency pitch to the sell in case you think you can wait to take you or your child’s treatment resistant drug cocktail until symptoms worsen. Depression is now a “progressive” disease say pharma-paid doctors after being known for decades as a self-limiting disease. (The one good thing you could say about depression; it would go away.)

And don’t think kids will outgrow mood problems either, says pharma. That erratic behavior is no doubt early mental illness that will become Worse if you’d don’t treat it in the bud. Even mothers of one-year-olds with the sniffles are told serious asthma is just around the corner if they don’t treat their toddler now.

Pharma is also having a field day with sleep because everyone is in the demographic. In fact comedian Chris Rock riffs about hearing a DTC ad that asks, “Do you fall asleep at night and wake up in the morning?” and recognizing himself. “Yeah, I got THAT,” he says.”

Not falling asleep soon enough of course is the disease of insomnia which can have “strains” like “middle-of-the-night” and “terminal” insomnia. But it also sets you up for — what’s the pharma euphemism — wakefulness problems the next day. And once you’re using a wakefulness aid like Adderall or Nuvigil, what do you bet you’ll have sleep problems?

Because of pharma-paid doctors, PR firms and industry subsidized medical journals and Web sites like WebMD, pharma is able to create new diseases (osteopenia, the “risk” of osteoporosis), perimenopause and Low T), “humanize” others by giving them nicknames (ED, RA, RLS, Hep C) and elevate others to public health problems like HPV/venereal warts. (It doesn’t hurt that Julie Gerberding, MD, former CDC head resurfaced as head of Merck vaccines after she left the government.)

But a more insidious sell are pharma subsidized “patient groups” that lobby FDA and state agencies about expensive drugs, often psychiatric. While these “patients” — often flown by pharma to testify at FDA hearings — pretend they can’t get needed drugs like terminal cancer patients, the issue is seldom availability but money: either they want a new use covered by insurers or don’t want an older, cheaper drug substituted.

The same patients appear on Web site testimonials and phony grassroots PSAs (public service messages) about the epidemic of depression or childhood mental illness. How can you tell they’re not real patients but pharma plants? The Web sites and PSAs look exactly like direct-to-consumer ads.

Illinois Attorney General Lisa Madigan’s ruling last week that the names of the 1.3 million people with Firearm Owners Identification cards (FOID) in the state is public information has gun owners up in arms, pun intended.

The same groups that declare no one would put a sign in front of their home saying NO GUN now fear the opposite. They’re no longer worried about their right to bear arms, they’re worried about their right to bear arms anonymously. Their right to privacy.

1,000 to 1,500 gun owners converged on the Statehouse this week in Springfield to oppose the decision and push for conceal and carry laws. In Peoria, Circuit Judge Scott Shore halted disclosure with a temporary restraining order. And in a related privacy concern, Amish Illinois residents lobbied their state representatives and law enforcement officers to keep their photos off their FOID cards after former Illinois State Police Director Jonathon Monken said the policy would be reversed.

The Illinois State Police’s Firearms Services Bureau conducts background checks and updates FBI databases on the 230,000 gun owner applications it receives a year. That amount rose to 326,000 in 2009 says bureau chief Lt. John Coffman which he attributes to last year’s Supreme Court decision that overturned Chicago’s handgun ban and extension of the card’s validity to 10 years, reports the State Journal-Register.

In 2005 Illinois State Police procedures were also under scrutiny when an employee with guns in his truck at the agency’s training academy shot his girlfriend and himself says the Chicago Tribune. A state police firearms official said the agency could have confiscated the man’s weapons but didn’t in a different court case.

Two years ago a similar name disclosure flap occurred when the Memphis Commercial Appeal decided to publish a searchable base of state firearm permit holders, despite gun owner identity protection laws in states like Florida, Ohio and South Dakota that sealed names. The Appeal found that 70 of 154 state permit holders had criminal records including Bernard Avery (arrested 25 times with a murder charge dismissed on mental competency) and Reginald Miller (a felon with 11 arrests). Oops!

Chris Cox, then executive director of Illinois’ NRA, wrote the Appeal after the disclosures and called the decision “dangerous” — as if gun safety advocates and employers were armed instead of gun-owners. Hello?

Even though 25 other states call gun owner information public or do not specifically call it private, pro-gun Illinois politicians say the public has no right to the information and have introduced counter legislation to Madigan’s ruling. The Illinois State Police has also refused to release the information, which it has held confidential for forty years, in defiance of Madigan’s ruling and a Freedom of Information Act request from the Associated Press.

Pro-disclosure and gun safety activists, on the other hand, say knowing whether a neighbor, daycare worker or the kid sitting next to your son or daughter at community college is armed is very much their business. Especially since 10,222  firearm  applications the Illinois State Police received in 2009 were denied and 5,952 were outright revoked.

Though the firearm owner information which Madigan wants to release would not include addresses, phone numbers or photos, gun activists worry they will be harassed in their community, by gun control activists or by anti-gun employers. They also worry that criminals will break into their houses and steal their weapons.

In fact, gun activists are so worried about others knowing they’re armed, you have to wonder if the weapons make them safe — or unsafe. And if they need to buy more weapons to defend their weapons.