The first week in May brought a new leader in France and new prospects for same sex couples seeking marriage. But at the American Psychiatric Association’s annual meeting in Philadelphia, attended by 11,000 psychiatrists, it was the same old same old. Instead of listening to the public outcry about overmedicated children, soldiers, elderly and everyday people watching too many drug ads, the psychiatry group re-affirmed its resolve to pathologize healthy people and even rolled out new groups to target.

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 overprescription of antipsychotic medications like Seroquel and Risperdal for PTSD, military figures closely linked to that overprescription 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.”[i]

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.

Just like ALEC, Big Pharma is doing the job of elected officials by writing legislation-ready bills for no charge, says the New York Times. The new bills seek to prevent health insurers from raising co-pay amounts to a price where patients are unable or unwilling to buy drugs, especially expensive drugs. When co-pays rise too high, many people engage in what Pharma calls “prescription abandonment”–leaving the prescription at the pharmacy “altar” or not refilling future prescriptions.

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 posttraumatic 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? END

Martha Rosenberg’s first book, Born with a Junk Food Deficiency: How Flaks, Quacks, and Hacks Pimp the Public Health, was published last week.

According to Science Times[1], the Tuesday science section in the New York Times, scientific retractions are on the rise because of a “dysfunctional scientific climate” that has created a “winner-take-all game with perverse incentives that lead scientists to cut corners and, in some cases, commit acts of misconduct.”

But elsewhere, audacious, falsified research stands unretracted–including the work of authors who actually went to prison for fraud!

Richard Borison, MD, former psychiatry chief at the Augusta Veterans Affairs medical center and Medical College of Georgia, was sentenced to 15 years in prison for a $10 million clinical trial fraud[2] but his 1996 US Seroquel® Study Group research is unretracted.[3] In fact, it is cited in 173 works and medical textbooks, misleading future medical professionals.[4]

Scott Reuben, MD, the “Bernie Madoff” of medicine who published research on clinical trials that never existed, was sentenced to six months in prison in 2010.[5] But his “research” on popular pain killers like Celebrex and Lyrica is unretracted.[6] If going to prison for research fraud is not enough reason for retraction, what is?

Wayne MacFadden, MD, resigned as US medical director for Seroquel in 2006, after sexual affairs with two coworker women researchers surfaced[7], but the related work is unretracted and was even part of Seroquel’s FDA approval package for bipolar disorder.[8]

More than 50 ghostwritten papers about hormone therapy (HT) written by Pfizer’s marketing firm, Designwrite, ran in medical journals, according to unsealed court documents on the University of California–San Francisco’s Drug Industry Document Archive.[9] Though the papers claimed no link between HT and breast cancer and false cardiac and cognitive benefits and were ghostwritten by marketing professionals not doctors, none has been retracted.

Pfizer/Parke-Davis placed 13 ghostwritten articles[10] in medical journals promoting Neurontin for offlabel uses, including a supplement to the Cleveland Clinic[11] but only Cochrane Database Systematic Reviews and Protocols has retracted the specious articles.[12]

Nor is the phony science just a product of “Big Pharma.” In 2008, JAMA was forced to print a correction stating that authors of an article arguing for a higher recommended dietary allowance of protein were, in fact, industry operatives. [13] Sharon L. Miller was “formerly employed by the National Cattlemen’s Beef Association,” and author Robert R. Wolfe, PhD, received money from the Egg Nutrition Center, the National Dairy Council, the National Pork Board, and the Beef Checkoff through the National Cattlemen’s Beef Association, said the clarification. Miller’s email address, in fact was smiller@beef.org, which should might have been the JAMA editors’ first tip-off.[14] The article has also not been retracted. END

Martha Rosenberg is an investigative health reporter. Her first book, Born With a Junk Food Deficiency, has just been released by Prometheus books.

http://www.barnesandnoble.com/w/born-with-a-junk-food-deficiency-martha-rosenberg/1106752596

[2] Steve Stecklow and Laura Johannes, “Test Case: Drug Makers Relied on Two Researchers Who Now Await Trial,” Wall Street Journal, August 8, 1997

[3] Richard Borison et al., “ICI 204,636, an Atypical Antipsychotic: Efficacy and Safety in a Multicenter, Placebo-Controlled Trial in Patients with Schizophrenia,” Journal of Clinical Psychopharmacology 16, no. 2 (April 1996): 158–69

[4] Alan F. Schatzberg and Charles B. Nemeroff, Textbook of Psychopharmacology (New York: American Psychiatric Publishing, 2009) p. 609

[5] http://www.scientificamerican.com/article.cfm?id=a-medical-madoff-anesthestesiologist-faked-data

[6] Scott Reuben et al., “The Analgesic Efficacy of Celecoxib, Pregabalin, and Their Combination for Spinal Fusion Surgery,” Anesthesia & Analgesia 103, no. 5 (November 2006): 1271–77.

[7] http://www.cbsnews.com/8301-505123_162-42840768/astrazenecas-sex-for-studies-seroquel-scandal-did-research-chief-bias-the-science/

[8] http://www.lifesciencesworld.com/news/view/12152 (BOLDER study)

[9] Martha Rosenberg, “Flash Back. The Troubling Revival of Hormone Therapy. Consumers Digest, November 2010

[10] Kristina Fiore, “Journals Aided in Marketing of Gabapentin,” MedPage Today, September 11, 2009

[11] United States District Court, District of Massachusetts, Report on the Use of Neurontin for Bipolar and Other Mood Disorders,http://i.bnet.com/blogs/neurontin-09513078512.pdf

[12] P. J. Wiffen et al., “WITHDRAWN: Gabapentin for Acute and Chronic Pain,” Cochrane Database Systematic Reviews and Protocols 16, no. 3 (March 16, 2011); P. J. Wiffen et al., “WITHDRAWN: Anticonvulsant Drugs for Acute and Chronic Pain,” Cochrane Database Systematic Reviews and Protocols no. 1 (January 20, 2010);

[13] http://jama.ama-assn.org/content/299/24/2891.extract

[14] http://www.obesity.org/newsletter/nl200407.html

News of a new “mad cow” in the United States could not come at a worse time.

The U.S. is in the process of trying to win back Japan and China’s business, not fully restored since the first U.S. mad cow, discovered in 2003. 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!

Despite three identified mad cows (not counting this week’s) the World Organisation for Animal Health (OIE) gave the U.S. “controlled risk” status. But trade officials say such a  status costs it $3 billion a year in foreign sales and are seeking “negligible risk” status. At least they were, until this weeks’ news.

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.”

Meanwhile, 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.

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 recycling” 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, 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.

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 2005*, 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. END

An earlier version of this article appeared on Truthout.org.

Martha Rosenberg’s first book, Born With a Junk Food Deficiency: How Flaks, Quacks, and Hacks Pimp the Public Health, has just been released by Prometheus Books.

.

New Orleans

Is it possible to deal on a daily basis with dog fighting, puppy mills, horse slaughter, baby seal clubbing, homeless pets, leghold-trapped wildlife, animal research, cockfighting and factory farming and still spread a message of hope and not despair? Yes if you are Wayne Pacelle, the charismatic and indefatigable president of the Humane Society of the United States (HSUS).

Pacelle chose to launch the sale of the paperback version of his bestseller, The Bond: Our Kinship with Animals, Our Call to Defend Them, at the Garden District Book Shop in metropolitan New Orleans on Tuesday because the city, “played such a remarkable role in defining the animal human bond,” after Hurricane Katrina. The event, as the summer-hot city quieted down the day after the Final Four Men’s Basketball Championship, was co-hosted by the Louisiana Society for the Prevention of Cruelty to Animals (LA-SPCA).

Two days after the human story about Hurricane Katrina first hit, the related animal story began to develop, recounts Pacelle: evacuees who left their pets, thinking they would be back in two days and unable to reach them; residents who didn’t evacuate but stayed with their pets and animal rescuers who rushed in to help animals even as more people fled.

With Pacelle were LA-SPCA’s CEO Ana Zorrilla and the group’s former director (during Katrina) Laura Maloney, now HSUS chief operating officer.

Hurricane Katrina, which struck New Orleans in 2005, did not just reveal atrocious lack of disaster preparedness for human evacuation and safety (especially for the poor, elderly, and infirm in hospitals and nursing homes) it also revealed atrocious lack of disaster preparedness for animal evacuation and safety. Pacelle described the evacuation of 200 Katrina dogs by airplane, thanks to Marilyn Pickens, and how well behaved the kenneled dogs were, “even in the middle aisles.”

As often happens after crises and suffering in U.S history, reform and new laws grew out of the Katrina crisis, like inclusion of pets in evacuation plans, said Pacelle. New laws, targeted toward dog fighters and even spectators, also grew out of quarterback Michael Vick’s conviction as well as dog fighting prevention programs for young people, said Pacelle.

Still, we can not “rescue our way” out of animal abuse or ignore animals whose suffering is out of the public eye which we are unwittingly “propping up,” cautioned Pacelle, holding up a folded piece of paper to show the amount of “living space” allotted a contemporary egg laying hen. Farm animals cannot be rescued because they are property and encroaching laws even limit the right to photograph or document their conditions, said Pacelle. Instead of having “one bad day”–the day they are slaughtered–every day of  factory farmed animals’ lives is suffering, immobilized in crates and cages in farm “warehouses.”

A fur garment we see in a store is removed from the 24 to 30 hours an animal actually writhed in a leghold trap to make it–and scientists do not even choose fur for warmth at locations like the North Pole but rather fabrics like Gortex, said Pacelle.

The primacy of the animal human bond has long been established and two-thirds of American households have animal members, observed Pacelle. “Pet” culture in fact debuted when the U.S lost its animal connections through urbanization just as humane laws surfaced when human effects on buffaloes and animals hunted into extinction became apparent.  Since humans have complete control over whether animals live or die and how they live, it is not an issue of “animal rights” but “human responsibility,” concluded the HSUS leader. END

Martha Rosenberg’s first book, Born With a Junk Food Deficiency: How Flaks, Quacks, and Hacks Pimp the Public Health, has just been released by Prometheus Books.

http://www.amazon.com/Born-Junk-Food-Deficiency-Quacks/dp/1616145935/ref=zg_bsnr_227563_20

Few remember the grisly summer of 2002 when four Fort Bragg soldiers’ wives were murdered within six weeks of each other and the malaria drug, Lariam, widely prescribed to troops deploying to Afghanistan and Iraq, was suspected as a factor in at least some of the killings.

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. Kevin, 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, black outs 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?

END

Martha Rosenberg’s first book, Born With a Junk Food Deficiency: How Flaks, Quacks, and Hacks Pimp the Public Health,  has just been released by Prometheus Books.

It is no consolation to the roughly one out of 600 families who lost their homes in the U.S. but Wall Street made a lot of money slicing and dicing mortgages it knew would implode, while hiding risks. Financial giants, like AIG, are still buzzing along and neither penalties or new laws will prevent a future crash, say financial analysts, because the risky business models have not really changed. In fact, occlusive business models with undisclosed risks could be strengthened under the U.S.’ pending JOBS Act, which actually strips regulatory laws enacted during the previous bubble–the 2000 Internet meltdown. Thanks for that.

A similar Big Pharma bubble, leavened with risky blockbuster drugs that also blew up, is now bursting. Almost 20,000 jobs have vanished at AstraZeneca, Novartis and Pfizer in the last 12 months alone. AstraZeneca has scrapped 21,600 more jobs since 2007.

Like Wall Street’s bundled high risk loans, the bubble created by Big Pharma’s blockbuster drugs in the 2000s created jobs in sales, advertising, public relations and medical communication agencies while enriching TV and radio stations, websites, medical journals and doctor/pitchmen. Until it didn’t.

And like the Wall Street bubble, many of Pharma’s “assets” were later revealed to be toxic and/or misleading. The FDA now warns that bestselling statin drugs like Lipitor and Crestor, even sold to children, are linked to memory loss and diabetes. Oops. And 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 ingredient in Lipitor with the active ingredient in Zetia, 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.”

In Europe, governments are no longer willing to pay the bubble 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,” says the New York Times. 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 similarly affordable bipolar drug are better than blockbuster psychiatric drugs that created Pharma’s 2000’s bubble.

Being a Pharma rep was probably the next best thing to working on Wall Street before the Vioxx scandal and gigantic settlements over blockbuster drugs like Zyprexa, Bextra, Celebrex, Geodon and Seroquel.  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?” Pharma is seeking new drug markets in “emerging” and poor countries and moving operations there. Workers and people willing to be drug trial subjects are a bargain in poor countries where many can’t understand drug risks or refuse them if they did. 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, where many can not afford the drugs they make, 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.

Yet like the forces behind the JOBS Act, some say U.S. regulators are 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? END

Martha Rosenberg’s first book, Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health, will be published by Prometheus Books in April.

Food safety representatives from the European Parliament’s Environment, Public Health and Food Safety Committee (ENVI)  told the European Commission in February they want a bill regulating animal cloning within a year. ENVI has insisted that meat or milk products from the offspring of clones be labeled and traceable.

Unfortunately, meat or milk from cloned animals in the US will not be labeled. Some say “is not labeled” because we are already eating it.

In 2008, the FDA ruled that products from clones and their offspring will not be labeled because they are “no different from food derived from conventionally bred animals”–the same thing that was said about rBGH-produced milk.  Nevertheless, the FDA asked producers to “voluntarily keep milk and meat from clones out of the food and feed supplies until we finish assessing their safety.” Key words: asked and voluntarily.

But a 2010 demonstration in England over possible unlabeled and illegal food from clones in that country revealed that clones may already be on the American dinner plate– with US food consumers being the last to know. The BBC, while reporting on the British cloned herd, said that cloned products have been in the US food supply for two years. Who knew?

Jim McLaren, president of Scotland’s National Farmers Union, concurred and told the press, “If you go to the US or Canada you will almost certainly be consuming meat and dairy products from cloned animals at every turn.” Margaret Wittenberg, global vice-president of Whole Foods Market,  agreed. United States customers are “oblivious” to cloned products in the food supply, she verified to the BBC. “You don’t hear about it in the media. And when you do tell people about it they look at you and say ‘you’re kidding! They’re not doing that are they? Why would they?’” Whole Foods says it bans the sale of cloned products.

When Agriculture Secretary Tom Vilsack was asked point-blank, during a 2010 trade mission in Canada, if “cloned cows or their offspring have made it into the North American food supply,’ he put no fears to rest. “I can’t say today that I can answer your question in an affirmative or negative way. I don’t know. What I do know is that we know all the research, all of the review of this is suggested that this is safe.” So much for informed public officials.

An FDA report written in collaboration with Cyagra, a Pennsylvania-based clone company, seeks to put public fears at rest over the brave new food. Not a big surprise since Cyagra, boasts about selling clone products to US butchers (who presumably sell to customers) and about its employees regularly dining on cloned products, say British new sources.

Since the first cloned mammal, Dolly the sheep, was created, cattle, horses, goats, pigs, and mice have been cloned, as well as dogs and cats, a mouflon sheep, a mule, and a racing camel. In fact, cloning doesn’t even make headlines anymore. But lengthy reports from both FDA and  European Food Safety Authority raise questions about the safety of milk and meat from cloned animals and their offspring, their welfare and protection from suffering and the soundness of the cloning process.

Why not let food consumers vote whether they want to support such food with their forks, say US and European consumers, by simply labeling them? END

Martha Rosenberg’s first book, Born With a Junk Food Deficiency: How Flaks, Quacks, and Hacks Pimp the Public Health, will be published in April by Prometheus Books.

http://www.amazon.com/Born-Junk-Food-Deficiency-Quacks/dp/1616145935/ref=zg_bsnr_227563_20

As the nation increasingly relies on sleeping pills, new information this week suggests they may not be as safe as thought.  Drugs like Ambien, Lunesta and Sonata, older drugs like Valium and barbiturates and even sedative antihistamines all correlate with a three fold increase in the hazard of death say researchers in this week’s British Medical Journal (BMJ). Some of the mortality stemmed from a “significant elevation of incident cancer,” say the researchers and subjects did not have pre-existing disease.

Sleeping pills have never  been Big Pharma’s finest hour.  In the 1960s, barbiturates were immortalized by Marilyn Monroe’s death and by the 1967 movie Valley of the Dolls, which starred Sharon Tate, soon before her grisly murder. In 1993, the sleeping pill Halcion was banned in the United Kingdom and other countries for causing amnesia, paranoia, depression, hallucinations, and violence in users. Travelers, among its biggest users, would find themselves on the other side of the Atlantic Ocean and not remember boarding a plane. And in 2001, a similar pill, Dalmane, was said to “increase the risk of an injurious accident more than five times normal,” at FDA/National Transportation Safety Board hearings.

And there were more transportation risks. Who can forget former Rhode Island representative Patrick Kennedy driving to Capitol Hill to “vote” at 2:45 a.m. on Ambien and other drugs and crashing his car in 2006?  Law enforcement officials reported that traffic accidents increased when Ambien became popular with some drivers not even recognizing the police officers there to arrest them. (Hey Dude–help me get my car out of this ditch!) The FDA soon issued warnings about such apparent sleeping pill blackouts– the potential of “complex sleep-related behaviors” that may include “sleep-driving, making phone calls and preparing and eating food (while asleep)”–for Ambien and twelve other sleeping pills. Sanofi-Aventis, Ambien’s manufacturer, was forced to publish ads telling people if they were going to take Ambien, to get in bed and stay there. (Or you’ll break out in handcuffs.)

Of 4,336 people on Ambien in the BMJ study, there were 265 deaths compared with 295 deaths among 23,671 people  not on Ambien.

Even though sleeping pills like Ambien, Lunesta, Sonata and Rozerem only decrease get-to-sleep time by 18 minutes according to a major government study, they have been a gold mine for Big Pharma since direct-to-consumer (DTC) advertising since everyone sleeps–or watches TV when they can’t. In FDA documents, Rozerem, worked no better than a placebo, but its sales shot up 60 percent thanks to DTC advertising, reported the New York Times.

To “grow” the insomnia market, Pharma has rolled out subcategories like it did with different kinds depression. You could have chronic, acute, transient, initial or delayed- onset insomnia. You could also have middle-of-the-night, early-morning or menopausal insomnia–or even non-restful sleep. But if further research confirms the BMJ findings, enduring the minutes before you fall asleep may be better for your heath than popping a pill. You can always watch the TV commercials for sleeping pills.

Two-thirds of U.S. adults are overweight and a third are obese, but few diet drugs have been able to make a dent in what is rapidly becoming our “gross national product.” Diet drugs have proved ineffective or dangerous or ineffective and dangerous. The popular Fen Phen was withdrawn almost fifteen years ago for killing at least 120 people. Meridia, another popular diet drug, was withdrawn in 2010 for increasing the incidence of cardiovascular events in patients.

Other diet drugs remain on the market but have unpleasant side effects. Alli and Xenical encourage weight loss by blocking the body’s absorption of fat but can cause “oily bowels” and “anal leakage.” Comics had a lot of fun with them when they were first approved with lines like “With Allies Like This, Who Needs Enemas?” and “Free coupon for Depends.”

In 2010, the FDA failed to approve three diet drug candidates: Contrave, a drug that includes Wellbutrin, an antidepressant that lacks the weight gain side effects associated with other antidepressants; Lorcaserin, which also includes an antidepressant-like drug; and Qnexa, which combines topiramate, an epilepsy drug patented as Topamax, and phentermine, the phen in Fen Phen.

Next week the FDA will reconsider Qnexa. Two years ago, an FDA advisory committee heard patient Erin Aycock testify that she lost 50 pounds on Qnexa. Others patients, on the drug-rating site askapatient.com, say they lost 10 percent of their body weight on Topamax but also sometimes lost their memory and hair too.  Oops. (In fact Topamax’ tendency to dumb people down is so well known it is referred to as “Stupamax” in the military where it is in wide use.)  Qnexa’s weight loss properties may stem from topiramate’s penchant for making food and beverages tastes bad, a side effect scores of users on askapatient cite. In 2009, the drug also received an FDA suicide warning (along with other seizure drugs) and in 2011, it received a warning that it may cause birth defects.

And phentermine the other drug in Qnexa? “I honestly can’t distinguish this drug from Adderall, or even cocaine,” says one phentermine user. “It might as well be called Prescription Coke.” Users report losing 50 and 60 pounds on phentermine, though many say they gained it back. Phentermine users also report being unable to sleep and chewing the insides of their cheeks as if they were chewing gum–a frequent side effect of “speed.” Phentermine is the half of  Fen Phen that remains on the market.

After hearing testimony in 2010, the FDA advisory committee voted ten to six against approving Qnexa because of concerns about depression, memory loss, birth defects and lack of long term data. Since then, both the drug’s safety profile and national obesity have worsened. Will opinions have changed given that both the drug’s good and bad features sound a lot like Fen Phen’s?