Category: Health

Johnson & Johnson Fined $1.2 Billion for Illegal Drug Marketing

The state of Arkansas has ordered Johnson & Johnson and one of its subsidiaries, Janssen Pharmaceuticals, to pay $1.2 billion in fines for deceptively marketing the antipsychotic drug Risperdal, approved to treat conditions like schizophrenia and bipolar disorder. The companies were accused of failing to provide adequate warning about potential side effects of the drug, which include diabetes, weight gain, neurological problems and increased risk of strokes and death in elderly patients with dementia.   Fletch Trammell, a lawyer in the case who had used Risperdal, said that J&J hid studies that showed Risperdal caused diabetes at a higher rate than a competing drug. The court also found nearly 240,000 instances in which the companies violated the state laws against Medicaid fraud, with each count representing one prescription for Risperdal written to a state Medicaid patient over a 3 1/2 year period. The fine for the Medicaid fraud portion of the case, at $5,000 per prescription, was the state’s minimum.  A 12 person jury deliberated for three hours before finding against J&J. Arkansas is just one of several states suing over Risperdal. South Carolina and Texas have already reached settlements with J&J in their lawsuits. J&J plans to appeal the Arkansas ruling, claiming it did not break the law and that the package insert that comes with the medication was approved by the U.S. Food and Drug Administration.

Main source: New York Times, April 11, 2012

Campaign Urges Hospitals to Evict McDonalds Restaurants

Corporate Accountability International (CAI), a group that challenges corporate abuses, posted an  open letter on its website asking hospitals that house McDonalds restaurants to end their contracts with the fast food chain to “stop fostering a food environment that promotes harm, not health.” The letter points out that the rates at which children suffer from diet-related illnesses like diabetes are “staggering,” and the problem is related in part to the consumption of junk food. Locating McDonalds stores in  hospitals is part of a marketing strategy, CAI says, that is aimed at imparting an aura of healthfulness to the food — a goal that is inconsistent with the goals of a health institution.  “Health professionals are devoted to caring for sick children and adults and to preventing illness. But these efforts cannot compete with the profit-driven mechanisms by which McDonalds and the fast food industry operate their business, and the toll that McDonalds’ practices have had on children’s health,” the letter states. CAI’s petition to get McDonalds out of hospitals is here.

Billboard Campaign Promotes Marijuana Legalization in Colorado

A big new billboard has appeared right over a liquor store near Mile High Stadium in Denver that shows a mainstream, straight-laced looking woman smiling with her harms folded, saying, “For many reasons, I prefer…marijuana over alcohol. Does that make me a bad person? RegulateMarijuana.org.” The board is the first in an educational campaign by backers of the Regulate Marijuana Like Alcohol Act, a measure that will appear on the state’s November election. The group backing the measure seeks to educate people about the ways that marijuana is safer than alcohol, specifically that it is less addictive than alcohol and tends to cause fewer adverse health effects. Users also cannot overdose on marijuana. The measure would permit limited possession and cultivation of marijuana by adults, and would let state and local governments in Colorado regulate the commercial production and distribution of marijuana or ban marijuana sales completely within their jurisdictions. On its website, the pro-legalization campaign says, “We are not suggesting that marijuana is better than alcohol … We are simply asserting that there are many good reasons to use marijuana instead of alcohol.”

Transnational Tobacco Companies Target Poor Countries

Thai child smoking (Photo from Thailand-th.net)

A new study reveals PR strategies transnational tobacco companies use behind the scenes to derail, delay and undermine public health policies in low- and middle-income countries. The authors uncovered six core strategies tobacco companies use in Thailand to interfere in tobacco control policymakin: (1) doing business with “two faces,” (2) working to influence people in high places, (3) “buying” advocates inside grassroots organizations, (4) putting up deceptive fronts, (5) using intimidation, and (6) undermining controls on tobacco advertising, promotion and sponsorship. The companies often apply several of the strategies simultaneously. Public health advocates in poorer countries have successfully counteracted these strategies by remaining vigilant to spot them, excluding tobacco companies from policymaking, restricting cigarette sales, keeping up pressure on the companies and working to assure adequate resources are dedicated to enforcing tobacco control regulations. The entire text of the article is available free in PDF form here.

Source: International Journal of Environmental Research and Public Health, March 27, 2012 (pdf)

 

Philip Morris Exec: Public Health Authorities are “Muesli-Eating, Stool-Watching Joggers”

In a January, 1988 speech to Philip Morris’ (PM) Australian sales force titled “The Challenge of Change,” John Dollisson, then head of Philip Morris Corporate Affairs Australia, describes the company as “at war” with public health advocates.  On Page 13, he describes the sales force as one of “our most effective weapons” in that war.  Dollisson displays blatant contempt for public health authorities when he calls them “Meusli-eating, stool-watching joggers who know what is best for all of us.”[Page 2] Dollisson discloses the strategies PM has employed to defeat public health efforts in Australia: funding lawsuits against the government, supporting a “spontaneous” smokers’ rights group, finding ways around state advertising bans, running their own ad campaigns during national “quit smoking” campaigns, using strategic sports sponsorships to deliver audiences to favored politicians, forming a “business/liberty group” to “defend freedoms and question the legitimacy of anti-business groups,” giving away gold “Benson & Hedges” pens actually worth $10 that customers “perceive” as being worth $50-60, and much more.

Vivid Anti-Smoking Ads Prompt Flood of Quitline Calls

On March 19, the U.S. Centers for Disease Control (CDC) started a new print and television ad campaign called “Tips from Former Smokers” that features real people offering tips on how to live with diseases caused by smoking or secondhand smoke. Ads show survivors of oral and throat cancer, strokes, amputations and heart attacks. The former smokers give tips like how to bathe, shave and get dressed with their conditions. The ads show amputees putting on their prosthetic limbs, and heart attack and lung cancer survivors show their surgical scars. The ads also show other grisly results of smoking that most people rarely or never get to see. The campaign has more than doubled calls to CDC’s quit line. From March 12 – March 18, the period just prior to the start of the ad campaign, the quit line got 14,437 calls. Between March 19 and March 25 — after the ads started running — the quit line got 34,413 calls. The ads are tagged with the number 1-800-QUIT-NOW, a toll-free number where smokers can get free quitting information and support.  Visits to CDC’s quit-smoking website, www.smokefree.gov, have tripled since the campaign began.

Philip Morris: “Get sick children on Oprah”

In 1993, the U.S. Environmental Protection Agency (EPA) officially listed secondhand tobacco smoke as a Group A Human Carcinogen, the same rating the agency gives to asbestos, radon gas and vinyl chloride. The listing was a public relations disaster for the tobacco industry, and their internal documents show how tobacco companies reacted. A 6-page Philip Morris planning document found in the files of Ted Lattanzio (Director of Philip Morris Worldwide Regulatory Affairs), lists strategies and budgets for fighting efforts to ban smoking in workplaces and public places.  Page 4 describes a strategy for dealing with public information about how childrens’ health is disproportionately affected by exposure to secondhand smoke:

“Shift the debate on ETS [environmental tobacco smoke] and children to: Are our schools and day care centers making children sick?”

Tactics proposed for making the public believe that schools and day care centers are making children sick (instead of secondhand smoke) include:

“Feed available information to National School Board Association in D.C.  Feed information to Oprah, et. al. Get sick children on the shows.  Research newspaper clippings of parents who keep children at home because of school environment — pass those on.  Why?  Shift the debate.  Why is EPA not spending research dollars on solving school problem?? I have the research budget for next year — not very much is going to identify or solve the school problem.  Get information to EPA Watch.”

Philip Morris’ estimated budget for the effort to blame day care facilities for making children sick was $100,000.

President Obama’s Defense of Planned Parenthood Draws Little Notice

Republican attacks on Planned Parenthood have drawn a lot of media attention in recent months, but a video message from President Obama in support of Planned Parenthood recently posted on the Internet drew little notice. In the video, Mr. Obama talks about how politicians are trying to deny millions of American women the health care they rely on. He says that when people hear “some professional politicians casually say they’ll get rid of” Planned Parenthood, what they are really talking about is eliminating the funding “for preventive care that millions of women rely on and leaving them to fend for themselves.” Mr. Obama talks about how he stood up to Republicans who wanted to shut down the government over funding for Planned Parenthood, and that it is wrong for legislators to play politics with women’s health. While he doesn’t mention it in the video, Obama has a personal stake in this issue. He was raised by a single mother who died at age 53 from ovarian cancer.

CVS Drug Stores Tout Healthy Image While Profiting from Disease & Death

Dr. Gerace's CVS protest ad

For 103 days now, Terence Gerace, Ph.D. has stood outside CVS pharmacies in Washington, D.C. protesting their sales of a product that is known to be deadly when used exactly as directed: cigarettes. In press releases and ads, CVS claims it works to improve health and lower health care costs for Americans, but all the while it continues to sell the leading causes of preventable death and disease in the U.S. No matter what they say in their ads, the truth is that CVS, and other national drug chains, like Rite Aid and Walgreens (pdf), do not care about health one bit. They care about profits, and every day they profit from both causing and curing disease. Pharmacies are among the most trusted sources of health information in the U.S., but for decades, national drug chains have actively colluded behind the scenes with tobacco companies not only to market cigarettes, but also to oppose legislation (pdf) to regulate tobacco. Dr. Gerace, a former Research Associate Professor in the Department of Epidemiology and Public Health at the University of Miami School of Medicine, knows all of this, so it’s no wonder he saw red after spotting a full-page CVS ad in the Washington Post that screamed, “To better manage chronic diseases, we needed a new kind of pharmacy…” Incensed, Dr. Gerace made a new sign out of the ad by adding the big words “NEW CVS Cigarette-Free!” above the headline. Now he uses this sign in his ongoing, one-man protest against CVS selling cigarettes. In 2010, the American Pharmacists Association issued a statement urging U.S. pharmacies to stop selling tobacco.  Boston and San Francisco have passed laws forcing pharmacies to stop selling cigarettes, and Target, the nation’s third-largest retailer chain, stopped selling cigarettes in 1996.  It is counter-intuitive, inimical to their mission and just plain two-faced for a business to portray itself as caring about people’s health while also selling cigarettes, but until a law forces them stop, CVS, as well as Rite Aid and Walgreens, plan to keep advertising that they care about health while continuing to sell the leading cause of death and disease in the U.S.

A Grassroots Effort to Track the Side Effects of Prescription Drugs

A new word has entered the lexicon: “Pharmageddon.” Wiktionary defines it as “a dystopian scenario wherein medicine and the pharmaceuticals industry have a net detrimental effect on human health and medical progress does more harm than good.” We are fast approaching pharmageddon, as drugs are increasingly fast-tracked to approval and only later found to do little or no good, or, even worse, to cause harm. In 2010, the U.S. Food and Drug Administration (FDA) pulled the breast cancer drug Avastin off the market, after having fast-tracked its approval. Over $6 billion worth of Avastin was sold before two follow up studies showed that the survival rate of patients who took Avastin was no better than patients who took other drugs. Not only did huge numbers of women take this essentially worthless drug to treat their breast cancer, but the listed side effects of Avastin included conditions severe enough to merit  a descriptor of potentially fatal several times in the drug’s informational brochure. Another factor in prescription drug danger is the fact that drug companies are increasingly engaging in criminal behavior aimed at boosting sales at any cost. In 2009, the drug maker Pfizer paid a record $2.3 billion fine and pled guilty to a felony for illegally promoting its painkiller Bextra. Pfizer paid kickbacks to doctors and dished out perks, like massages and all-expense-paid trips to fancy resorts, to get doctors to prescribe Bextra for off-label, or unapproved, uses. Like Avastin, Bextra was ultimately pulled off the market due to safety concerns. This wasn’t the first or even the second time Pfizer had been caught marketing drugs illegally, either. It was the fourth time just  since 2002 that FDA had fined Pfizer or one of its subsidiaries fined for marketing its drugs in an illegal manner.

Taking prescription drugs is increasingly fraught with danger. Adverse side effects have risen over the years to where they are now a leading cause of death, disability, and illness.  It is estimated that only 1 to 10 percent of adverse drug events ever get reported to the FDA. Many people suffer side effects from prescription drugs that are considered “medically mild” but that are nonetheless disabling, like detrimental effects on memory, concentration, and judgment. Often people report adverse side effects to their doctors, only to be told there is little or no evidence linking their problem to the drug. This lack of information is not a mistake — it traceable to the fact that most of the data on prescription drugs is the property of  the pharmaceutical companies, since the companies run most of the clinical trials for the drug. Up to 60% of these trials are never publicly reported. For obvious reasons, companies have a vested interest in not fully disclosing the side effects of their products.

Recognizing the extent and severity of the problem of prescription drug side effects, Dr. David Healy, author of a just-published book titled “Pharmageddon,” along with group of people who, like Healy, have risked their careers to speak out about adverse drug events, are developing a free website where people can share information on the side effects they experience while taking prescription drugs.  RxRisk.org, in effect, aims to crowd-source real-time data about drug side effects, to create a fuller picture of exactly how these drugs  are really affecting people. The site accepts no advertising and is not linked in any way to big Pharma. Use of it is free and anonymous. The site also helps users research drugs they are taking. People who report information on the side effects they experience can get a free report they can take to their doctors, to encourage fuller and more informed discussion of their treatment. Doctors can also add information to their patients’ reports. RxRisk.org’s advisory board is comprised of people with relatives injured by adverse drug events, health care activists and independent scientists. The site is currently in beta development, but RxRisk.org is a much-needed grassroots effort to track the side effects of prescription drugs and build a record of them, so that it eventually it will become unreasonable to say the problem can’t be happening in at least some people. Visit the new, consumer-friendly drug-tracking website here.

Pink Slime Manufacturer Starts New Website, “PinkSlimeIsAMyth.com”; USDA Backs off Pushing Pink Slime in Schools

Pink Slime (photo by Beef Products, Inc.)

Beef Products, Inc. (BPI), the manufacturer of pink slime, has started a new website, PinkSlimeIsAMyth.com, to battle the growing tide of anti-slime public sentiment. One of the pages of Beef Products’ new website attempts to discredit Kit Foshee, who formerly worked as Manager of BPI’s Quality Assurance Group. Foshee, who questioned the byproduct’s safety, has become an outspoken critic of pink slime — a position the company characterizes as “revenge.” Meanwhile, the U.S. Department of Agriculture is sticking to its story that “Lean Finely Textured Beef” (pink slime) is safe, but on March 15 the agency bowed to public pressure and issued a press release saying it will now “adjust procurement specifications” to give schools “additional options in procuring ground beef products.” Translation? USDA will now offer schools a choice whether or not to feed their students ground beef that contains pink slime. The change assumes that USDA will now distinguish beef containing the additive from beef that  does not. Ground beef is currently not labeled as to whether it contains the additive or not since USDA considers the additive “beef.” Pink slime is a cheap meat filler made of rejected meat scraps that are heated, mixed, and treated with ammoniated gas to kill pathogenic bacteria like E Coli and salmonella.

NRC Dings Colorado for Botched Approval of New Uranium Mine

The Nuclear Regulatory Commission says the Colorado Department of Public Health and the Environment (CDPHE) failed to hold proper public hearings before licensing a private energy company to build the first uranium mill in the country in decades. The Colorado Department of Public Health and the Environment (CDPHE) held public meetings, rather than public hearings before licensing the mill, the latter being a formal legal proceeding that involves testimony under oath and cross-examination. Energy Fuels Resources Corporation asked the state to build the Pinion Ridge Uranium Mill in the Paradox Valley near Nucla in western Colorado to supply nuclear power plants and other technological users of radioactive material, but residents of western Colorado are wary. Past uranium mines have left an expensive, long-lasting and toxic legacy of contamination that cost taxpayers over a billion dollars to clean up. Western Colorado has been particularly hard-hit by these environmental disasters. Energy Fuels is enticing local residents to support the new mine by promising it

Map of U.S. uranium mines, showing high concentration in western Colorado

will supply high-paying jobs with health benefits. The Nucla area has fallen on economic hard times in recent years, so some residents are clamoring for the mine to be built to help turn the community around, but others who remember the past aren’t taking the bait. The state ordered Energy Fuels to pay $12 million in surety funds to pay for cleanup in case the mill contaminates water, soil or air, but opponents argue that amount is nowhere near enough, and they’re right. In 2010, the Denver Post found the cost of cleaning up environmental contamination caused by uranium mills in Colorado has ranged from $50 million to $504 per mill.

Main source: Denver Post, March 15, 2012

How Do You Like it, Guys?

Ohio state Senator Nina Turner (D-Cleveland) has introduced a bill to regulate men’s access to erectile dysfunction (ED) drugs. The bill mandates that prior to getting a prescription for Viagra, Cialis or similar ED medications, men would have to undergo a session with a sex therapist, have a cardiac stress test and obtain a notarized affidavit signed by a sexual partner affirming impotency. Turner’s bill adheres to guidelines issued by the U.S. Food and Drug Administration, which recommend that prior to prescribing erectile dysfunction drugs, doctors determine whether a male patient’s sexual dysfunction is due to physical or psychological causes. Turner explains that she is concerned about men’s reproductive health, and says if state policymakers introduce bills subjecting women to ultrasound tests before getting an abortion, legislators should also be able to legislate male reproductive health issues.

The Lap Band Trap

One of the ubiquitous L.A. billboards advertising lap band surgery.

Billboards showing up across the U.S. encourage people to shed extra pounds by undergoing lap band surgery. The ads leverage people’s insecurities about their weight to drive them to an expensive and risky surgical solution. A particularly aggressive lap-band billboard campaign has plagued image-conscious southern California for months. Huge ads along L.A. freeways screamed, “Lose weight with the lap-band! Safe, 1-hour, FDA-approved. 1-800-GET THIN”. The ads made lap-band surgery sound fast and easy. They were also practically inescapable. One L.A. freeway had 25 lap-band billboards in just a four-mile stretch, and the boards were up for months alongside most of southern California’s freeways. They bore no information about the qualifications needed for the surgery, or the risks it poses — not even in fine print. People who dialed 1-800-GET THIN heard an automated greeting from a “celebrity physician” assuring them the lap band is approved by the FDA and is “extremely effective” at helping people lose weight. But just like the billboards, the telephone recording didn’t mention any risks, contraindications or qualifications to get the surgery. In addition to the ubiquitous billboards, 1-800-GET THIN ads also appeared in newspapers, on bus placards, on TV and the Internet, featuring people who claimed to have shed huge amounts of weight and regained control over their lives through lap-band surgery.

Dangerous Ads, Bad Doctors

Many people who called 1-800-GET THIN found they got more than they bargained for — way more, and not in a good way.  Laura Faitro was one of those people.

Ms. Faitro underwent the lap band surgery after calling 1-800 GET THIN. The procedure was performed in a day-surgery suite of an office building, and her insurance covered just $3,000 of the $12,200 cost. During the procedure, her doctor lacerated her liver and called other doctors in to assist him. He discharged Ms. Faitro shortly after her surgery, even though she complained of severe abdominal pain. Soon after the doctor sent her home, she had to go to the emergency room for her  abdominal pain. Five days later, Ms. Faitro was dead from “multi-organ failure due to shock secondary to bleeding and sepsis” in her abdominal cavity. Her husband, John Faitro, recently filed a class action against the surgery centers that advertised the procedure. But why a class action if this was an isolated case?

Because it’s not an isolated case.

Laura Faitro is one of at least five southern California patients who lost their lives after responding to the 1-800-GET THIN ads and having lap-band surgery done at one of the clinics affiliated with the ad campaign. The clinics were operated by two doctors, Michael and Julian Omidi, brothers affiliated with a Beverly Hills medical business called TopSurgeons. Investigation later revealed that Julian Omidi’s medical license had been revoked after the California Medical Board found he had lied on his license application. He omitted information from his application that would have led the Board to discover that, while attending the University of California at Irvine from 1986-1990, he had been expelled over his involvement in the burglary of exam papers. The California Medical Board also sanctioned Julian’s brother, Michael, with three years’ probation for gross negligence in his treatment of liposuction patients in 2005. Michael Omidi had improperly administered anesthetics, and allowed unlicensed staff to suture up patients and even perform liposuction.

In December, 2011, FDA took action against 1-800-GET THIN-affiliated clinics and their misleading ad campaign. That same month, FDA issued a warning to consumers about the fraudulent lap band surgery ads, and the risks and side effects of such surgery.  FDA has also issued warning letters to advertisers about misleading lap band surgery ads. In February, 2012, Allergan, manufacturer of the lap-band, announced that it would  stop selling the device to surgery centers affiliated with the 1-800-GET THIN ads. On February 8, 2012, the Los Angeles Times reported on a whistleblower lawsuit by two former surgery center employees who allege that clinics affiliated with the 1-800-GET THIN ads operated unsanitary surgical facilities and padded their bills with extra charges for medically unnecessary procedures and surgeries they never actually performed.

Widespread, Uncritical Promotion of Lap Band Surgery

Lap band billboard in Grand Junction, Colorado

Despite the lap-band surgery debacle unfolding in California, the multiple deaths associated with the lap-band and FDA’s growing number of warnings about lap-band ads and about the procedure itself, direct-to-consumer advertising for lap-bands is now spreading throughout the country. Messages pushing the surgery are targeting weight-conscious consumers across a range of media. On January 26, 2012, for example, an NBC TV affiliate in Grand Junction, Colorado, ran a completely uncritical local TV news story about lap-band surgery. The report focused on a single patient who so far has suffered no ill effects from the surgery. Like the ads that flooded L.A., the NBC story failed to mention any potential side effects, risks, qualifications or contraindications for the surgery, or FDA’s ongoing sanctions against advertisers for misleading ads that make the procedure sound quick and simple. Nor did the report mention lap-band patients’ deaths. Coincidentally, the NBC news report appeared at the same time billboards started showing up in Grand Junction promoting lap-band surgery. While the ads are less aggressive than California’s, they still lack any warnings about the risks or side effects of the procedure, as required by FDA. A call to the reporter at the Grand Junction NBC affiliate who did the lap band story said she was unaware that billboards promoting the procedure had gone up at the time she did the news report, and insisted the idea for the story was entirely her own.

Typical lap-band ad graphic

FDA continues to post consumer updates on the serious risks and side effects of gastric bands. They also post information about serious patient complaints about lap-bands, like this one, where a lap band slipped and left “three quarters” of the patient’s stomach “in a necrotic state.” The patient complained of throwing up for days, got dehydrated, and developed a rapid heart beat. It wasn’t until emergency surgery was done that doctors discovered her lap-band had slipped.

So far, advertisers have ignored FDA requirements that they make people aware of the dangers and side effects of bariatric surgery. That could be intentional. If they perform this type of operation purely as an elective surgery on people who don’t fit the medical qualifications, the surgery must be paid for out of pocket, without the involvement of insurance companies. That makes the procedure a cash cow for surgical centers and doctors who perform it, which explains the ubiquity of the ads promoting it.

Granted, lap band surgery has the potential to greatly benefit some people who are medically qualified for the procedure and who work with reputable doctors to have the surgery done properly, with appropriate follow-up care. But common sense dictates that the right way to decide to undergo a risky surgical procedure is not from reading roadside billboards put up by ruthless doctors who care more about money than patient care. Every surgical procedure has risks. Before considering gastric surgery, people need to do a lot of homework, ask a lot of questions, and thoroughly weigh the pros and cons. Lap-band surgery should draw even more scrutiny because of the insidious and dangerous way it is being marketed to large numbers of clueless people — many of whom, like so many of us, are undoubtedly insecure about their weight, and lack  a medical education.