PRESCRIPTION DRUG UNDERNEWS
The Progressive Review
TOWARDS NATIONAL HEALTHCARE
Compiled by the Project on Government Oversight. Government contracts to companies with histories of misconduct such as contract fraud and environmental, ethics, and labor violations.Drug firms included.
Politico - Politico has obtained a draft copy of TPPs intellectual property chapter as it stood on May 11, at the start of the latest negotiating round in Guam. While U.S. trade officials would not confirm the authenticity of the document, they downplayed its importance, emphasizing that the terms of the deal are likely to change significantly as the talks enter their final stages. Those terms are still secret, but the public will get to see them once the twelve TPP nations reach a final agreement and President Obama seeks congressional approval.
Still, the draft chapter will provide ammunition for critics who have warned that TPPs protections for pharmaceutical companies could dump trillions of dollars of additional health care costs on patients, businesses and governments around the Pacific Rim. The highly technical 90-page document, cluttered with objections from other TPP nations, shows that U.S. negotiators have fought aggressively and, at least until Guam, successfully on behalf of Big Pharma.
The draft text includes provisions that could make it extremely tough for generics to challenge brand-name pharmaceuticals abroad. Those provisions could also help block copycats from selling cheaper versions of the expensive cutting-edge drugs known as biologics inside the U.S., restricting treatment for American patients while jacking up Medicare and Medicaid costs for American taxpayers.
Theres very little distance between what Pharma wants and what the U.S. is demanding, said Rohit Malpini, director of policy for Doctors Without Borders.
Boing Boing - More than 100 Americans die each day from prescription drug overdoses, mostly painkillers. That's more daily deaths than from car accidents, gunshot wounds, or suicides. In California, two county District Attorneys are suing five of the biggest drug companies in the world, and the lawsuits include the same kind of arguments once used against big tobacco industry, demanding "public protection."
All of the nation's drug and medical device makers must soon begin publicly reporting payments they make to U.S. physicians, according to final regulations announced t by the federal government.
A recent study found that 7 percent of all visits to a primary care doctor include a prescription for antidepressants.
MAJOR MEDIA HYPE ANOTHER PHARMA FUNDED STUDY OF STATINS
Progressive Review - The Washington Post, running a front page study supporting the use of statins by healthy people, took 24 paragraphs to reveal that the study was funded by Asta Zeneca, which makes Crestor. The Post cited a researchers claim that "the company had no influence over the analysis" even thouhgh "he and his hospital receive royalties from the high-sensitivity CRP, or HSCRP, test, adding that "other researchers said that was no reason to doubt the findings."
If the Post had covered auto safety this way it would have happily accepted a report funded by GM that seat belts weren't really necessary. And, of course, there was no mention of reports of muscle deterioration and memory loss from use of statins or of natural alternatives include red yeast rice. Maybe the editors just forgot. The New York Times story was just as bad.
Here's one important thing to remember about all medical research. Since 1850, the life expectancy of a white male has increased 37 years and 41 years for a white female, but over half that increase is the result of higher survival rates of those under 30. By the time you reach 70, all the money and effort we have spent on medicine has improved life expectancy by four years. Four white males over 60, life expectancy has gone up five years. Yet a major part of pharma marketing is directed to this audience.
NY Times. After a series of stinging investigations of individual doctors' arrangements with drug makers, Senator Charles E. Grassley, Republican of Iowa, is demanding that the American Psychiatric Association, the field's premier professional organization, give an accounting of its financing. . .
"I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions," Mr. Grassley said Thursday in a letter to the association.
ALTERNET The New York Times reported the following about Joseph Biederman: "A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful anti-psychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given congressional investigators."
Due in part to Biederman's influence, the number of American children and adolescents treated for bipolar disorder increased 40-fold from 1994 to 2003, and as Bloomberg News reported (September 2007), "The expanded use of bipolar as a pediatric diagnosis has made children the fastest-growing part of the $11.5 billion U.S. market for anti-psychotic drugs."
Pediatrician and author Lawrence Diller notes about Biederman, "He single-handedly put pediatric bipolar disorder on the map." Biederman has been in a position to convince many doctors to diagnose bipolar disorder in children and to medicate them with anti-psychotic drugs. In addition to being a professor at Harvard, Biederman is also chief of research in pediatric psychopharmacology at the Massachusetts General Hospital, which publishes more than 30 papers yearly on psychiatric disorders. And Biederman himself has authored and co-authored approximately 500 articles, 70 book chapters, and more than 450 scientific abstracts, as well as being on the editorial board of many professional journals. . .
In addition to his popularization of bipolar disorder for children, Biederman is one of the most significant forces behind the commonplace diagnosis of attention deficit hyperactivity disorder. Congressional investigators also found that Biederman conducted studies of Eli Lilly's attention deficit hyperactivity disorder drug Strattera that were funded by NIH at the same time he was receiving money from Lilly that exceeded the maximum amount permitted.
SSRI STORIES is a collection of 2200 news stories with full media articles, mainly criminal in nature, that have appeared or that were part of FDA testimony in either 1991, 2004 or 2006, in which antidepressants are mentioned. Antidepressants have been recognized as potential inducers of mania and psychosis since their introduction in the 1950s. Since the introduction of Prozac in December, 1987, there has been a massive increase in the number of people taking antidepressants. Preda and Bowers reported that over 200,000 people a year enter a hospital with antidepressant-associated mania and/or psychosis.
HOW AMERICA GOT SOLD ON STATINS
ALTERNET - No doubt you've heard about the recent Business Week cover story, "Do Cholesterol Drugs Do Any Good?", which blew the lid off the theory that "statins" -- drugs like Lipitor, Crestor, Mevacor, Zocor and Pravachol -- can cut the odds that you will die of a heart attack by slowing the production of cholesterol in your body and increasing the liver's ability to remove LDL, or "bad cholesterol," from your blood.
It's true that these drugs can help some people -- but not nearly as many as we have been told. Moreover, and this is the kicker, we don't have any clear evidence that they work by lowering cholesterol.
Although medical research suggests that statins can definitely benefit one group -- men under 70 who already have had a heart attack -- researchers are no longer convinced that the drugs stave off a second attack by lowering the patient's cholesterol. The drugs do lower cholesterol, but that is not what helps the patient.
In other words, researchers are questioning the bedrock assumption that high levels of "bad cholesterol" cause heart disease. "Higher LDL levels do help set the stage for heart disease by contributing to the buildup of plaque in arteries. But something else has to happen before people get heart disease," Dr. Ronald M. Krauss, director of atherosclerosis research at the Oakland Research Institute, told Business Week. "When you look at patients with heart disease, their cholesterol levels are not that [much] higher than those without heart disease," he added. "Compare countries, for example. Spaniards have LDL levels similar to Americans', but less than half the rate of heart disease. The Swiss have even higher cholesterol levels, but their rates of heart disease are also lower. Australian aborigines have low cholesterol but high rates of heart disease.". . .
But hold onto your hats, I still haven't gotten to what is most shocking about the cholesterol story. What raises my blood pressure is the knowledge that Business Week's scoop isn't really "new" news.". . . The truth is that medical researchers have been questioning for many years the theory that widespread use of statins to lower cholesterol will save lives.
You can find the research questioning the benefits of statins in medical journals like Lancet (2001) and BMJ (2006), as well as in reports from medical conferences ("Tales From the Other Drug Wars," 1999).
Occasionally, doubts popped up in the mainstream press and then disappeared.
Five years ago, veteran healthcare blogger Matthew Holt pointed to a BMJ article suggesting that statins might be no better than aspirin. That same year, Holt raised pointed questions regarding the risk of taking statins, including possible memory loss."
Nevertheless, the very next year, the National Cholesterol Education Program at the U.S. National Heart, Lung and Blood Institute issued new recommendations that drastically lowered the threshold for statin therapy. . . The bottom line: NCEP was urging millions of Americans to go on statins.
WOULD TOM PAINE AND EMMA GOLDMAN BEEN DIAGNOSED AS ODD AND GIVEN RITALIN?
BRUCE LEVINE, ALTERNET - For a generation now, disruptive young Americans who rebel against authority figures have been increasingly diagnosed with mental illnesses and medicated with psychiatric (psychotropic) drugs.
Disruptive young people who are medicated with Ritalin, Adderall and other amphetamines routinely report that these drugs make them "care less" about their boredom, resentments and other negative emotions, thus making them more compliant and manageable. And so-called atypical antipsychotics such as Risperdal and Zyprexa -- powerful tranquilizing drugs -- are increasingly prescribed to disruptive young Americans, even though in most cases they are not displaying any psychotic symptoms. . .
In 1980, the American Psychiatric Association created oppositional defiant disorder, defining it as "a pattern of negativistic, hostile and defiant behavior." The official symptoms of ODD include "often actively defies or refuses to comply with adult requests or rules" and "often argues with adults." While ODD-diagnosed young people are obnoxious with adults they don't respect, these kids can be a delight with adults they do respect; yet many of them are medicated with psychotropic drugs.
An even more common reaction to oppressive authorities than overt defiance is some type of passive defiance.
John Holt, the late school critic, described passive-aggressive strategies employed by prisoners in concentration camps and slaves on plantations, as well as some children in classrooms. Holt pointed out that subjects may attempt to appease their rulers while still satisfying some part of their own desire for dignity "by putting on a mask, by acting much more stupid and incompetent than they really are, by denying their rulers the full use of their intelligence and ability, by declaring their minds and spirits free of their enslaved bodies."
Holt observed that by "going stupid" in a classroom, children frustrate authorities through withdrawing the most intelligent and creative parts of their minds from the scene, thus achieving some sense of potency.
Going stupid -- or passive aggression -- is one of many non-disease explanations for attention deficit hyperactivity disorder. Studies show that virtually all ADHD-diagnosed children will pay attention to activities that they enjoy or that they have chosen. In other words, when ADHD-labeled kids are having a good time and in control, the "disease" goes away. . .
It would certainly be a dream of Big Pharma and those who favor an authoritarian society if every would-be Tom Paine -- or Crazy Horse, Tecumseh, Emma Goldman or Malcolm X -- were diagnosed as a youngster with mental illness and quieted with a lifelong regimen of chill pills. The question is: Has this dream become reality?
NEGATIVE REPORTS ON ANTI-DEPRESSANTS KEPT FROM THE PUBLIC
BBC - The effectiveness of a dozen popular antidepressants has been exaggerated by selective publication of favorable results, according to a review of unpublished data submitted to the Food and Drug Administration.
Since the overwhelming amount of published data on the drugs show they are effective, doctors unaware of the unpublished data are making inappropriate prescribing decisions that aren't in the best interest of their patients, according to researchers led by Erick Turner, a psychiatrist at Oregon Health & Science University. Sales of antidepressants total about $21 billion a year, according to IMS Health.
SCIENCE DAILY - A new study by two York University researchers estimates the U.S. pharmaceutical industry spends almost twice as much on promotion as it does on research and development, contrary to the industry's claim. The researchers' estimate is based on the systematic collection of data directly from the industry and doctors during 2004, which shows the U.S. pharmaceutical industry spent 24.4% of the sales dollar on promotion, versus 13.4% for research and development, as a percentage of US domestic sales . . .
USA TODAY - Few patients complain about leaving the doctor's office with free drug samples. . . A study, however, gives ammunition to critics who want to do away with samples: Most of the free medications, the report says, actually go to wealthier patients who have insurance. . . Patients with the highest incomes were the most likely to get free samples, according to a survey of nearly 33,000 Americans in the February issue of the American Journal of Public Health. Only 28% of those who got samples were poor, whether insured or not, with incomes less than twice the federal poverty level - $18,400 for a family of four in 2003, when the survey was taken.
FDA OFFICIALS MET 112 TIMES WITH PHARMA LOBBYISTS BUT ONLY FIVE TIMES WITH CONSUMER ADVOCATES
RITA RUBIN, USA TODAY - While revising their drug-review policy last year, Food and Drug Administration officials met 112 times with industry representatives but only five times with consumer and patient groups, according to data from the House Appropriations Committee.The FDA provided the data in response to questions submitted in March by Rep. Maurice Hinchey, D-N.Y. . . "The FDA has essentially become the government affairs office of the pharmaceutical industry," Hinchey said in a statement, which called the relationship between the agency and industry "far too cozy and inappropriate." Hinchey is the author, and Bart Stupak, D-Mich., the chief co-sponsor of an FDA reform bill that would prohibit the agency from collecting fees from the companies it regulates. Instead, the money would be deposited into the general fund of the U.S. Treasury. According to the Appropriations Committee, two officials of the Biotechnology Industry Organization and two officials of the Pharmaceutical Research and Manufacturers Association attended at least half of the 112 meetings.
LEADING DOCTOR WARNED OF DANGERS OF AVANDIA SEVEN YEARS AGO; FDA KNEW OF PROBLEMS
STEPHANIE SAUL AND GARDINER HARRIS, NEW YORK TIMES - A leading diabetes doctor sent the Food and Drug Administration a letter seven years ago that warned of the heart risks of the drug Avandia. And in the next year, the FDA reprimanded the drug's maker for playing down safety concerns, according to documents from 2000 and 2001. The documents, found in a reporter's search of the FDA's database, indicate that the agency had been warned of safety concerns with the Type 2 diabetes treatment Avandia, and that the drug's maker, GlaxoSmithKline, was seeking to minimize Avandia's risks, before some of the same cardiovascular concerns were brought to public attention on Monday in an article and an editorial in The New England Journal of Medicine. The FDA has acknowledged that the company alerted the agency to concerns about a cardiovascular risk as early as 2005, based on the company's analysis.
HOW THE DRUG INDUSTRY CORRUPTS MEDICINE WITH SALES TECHNIQUES
In the journal, Plos Medicine, a former drug rep and a physician who researches drug marketing reveal the tactics used by drug reps to manipulate physicians into selling drugs. "Drug reps increase drug sales by influencing physicians, and they do so with finely titrated doses of friendship," say the authors, Adriane Fugh-Berman (Georgetown University Medical Center) and Shahram Ahari, a former drug rep for Eli Lilly who now works for the School of Pharmacy at University of California San Francisco. The specific strategy used by a drug rep to manipulate a physician, say the authors, depends very much on the personality of the doctor. A friendly, outgoing physician is the easiest to influence, because the rep can use the "friendship" to request favors, in the form of prescriptions. If a physician refuses to meet with a rep, "their staff is dined and flattered in hopes that they will act as emissaries for a rep's message."
Physicians who end up prescribing the rep's drugs are amply rewarded with gifts, such as golf bags or silk ties. In the paper, Mr Ahari shares his experience as a company insider. For example, when faced by a physician who preferred to use a competitor drug rather than Mr Ahari's drug, "the first thing I want to understand," he says, "is why they're using another drug instead of mine. If it's a question of attention, I commit myself to lavishing them with it until they're bought."
Drug companies purchase data on physician's prescribing habits in order to identify those prescribers who might be open to influence by drug reps, say the authors. Many doctors don't even realize that data on their prescribing habits can be bought by drug companies. Another technique that drug reps use is to give doctors "free" drug samples, which the doctors can give to patients as a gift. Studies consistently show that samples influence prescribing choices, say Fugh-Berman and Ahari.
"Reps provide samples only of the most promoted, usually most expensive, drugs, and patients given a sample for part of a course of treatment almost always receive a prescription of the same drug." A sales force of 100,000 drug reps (one drug rep per 2.5 targeted physicians) is providing "rationed doses of samples, gifts, services, and flattery" to those physicians who are likely to prescribe the rep's drug.
"Every word, every courtesy, every gift, every piece of information provided is carefully crafted" say the authors, "not to assist doctors or patients, but to increase market share for targeted drugs."
MERCK HUSTLING GARDASIL GUYS, TOO
PHARMALOT - A recent three-day event at the University of Chicago campus was held to promote awareness of HPV and the new vaccine everyone has been talking about. And it was co-sponsored by Peer Health Educators, a student program, and three companies: Sony, Avon and Merck.
One day, there were free makeovers. Another brought live music. And there was a day devoted just to discussing men's health. "We felt that it's very rare that there's a men's health event on campus. We wanted to bring men's health into a seemingly women-specific issue," Colleen Christensen, a second-year Peer Health Educator, tells the Chicago Maroon, the school newspaper.
Not only were free coffee and t-shirts given away, so were little bags of peanuts labeled with instructions on how to give 'self-testicular exams.' Peanuts? Why not beer bottles? Anyway, here's the message young men: One day, you won't have to worry that your short and curlies are sporting warts or growing harmful cells if the Merck vaccine is approved for fellas like you.
A similar event is being held at Ohio State University as part of a pilot program, and Merck plans to sponsor the same thing at 20 other universities this fall. By the time Merck convinces the FDA to approve Gardasil For Guys, a whole generation of educated young men will be primed for a shot. And they'll no longer have to associate peanuts with tricky maneuvers.
SOME INSURANCE COMPANIES NOT PAYING FOR GARDASIL
KAISER - Some health insurance companies are not covering Merck's human papillomavirus vaccine Gardasil and others only cover part of the vaccine's cost, the Detroit News reports. According to the News, many physician offices are requiring patients to pay for Gardasil up front or sign a waiver stating they will pay for the vaccine if their insurance company does not. . . According to some Detroit-area physicians, the full cost of the vaccine, which is given in three injections during a six-month period, is about $450. Two of the largest insurance providers in southeast Michigan, Health Alliance Plan and Blue Cross Blue Shield of Michigan, provide coverage for the vaccine. BCBS only pays for the HPV vaccine when the plan has immunization coverage, which is included in most employer groups, an unnamed company spokesperson said. According to the News, some health insurance plans stop immunization coverage at age seven or 17. In addition, some insurance companies that cover Gardasil have annual limits on preventive care that might be lower than the cost of the vaccine. "The insurance issue is a nightmare," April Sarvis, a Bloomfield Hills, Mich.-based ob-gyn, said, adding that some physicians are not offering Gardasil because insurance plans are not paying the full cost
PHARMAS ON THE PROWL ELSEWHERE
RITA RUBIN, USA TODAY - Pfizer, faced with the potential loss of billions of dollars as patients with high cholesterol switch from Lipitor to generic Zocor, has been helping doctors wage a letter-writing campaign to slow the tide. Lipitor's U.S. patent doesn't expire until March 2010, but health plans are encouraging patients and doctors to switch to the cheaper generic Zocor, or simvastatin.
Generic simvastatin became available in the USA last June. By December, doctors had written 2.5 million prescriptions for it, Consumers Union says. Lipitor still accounted for 43% of all statin prescriptions in the latter half of 2006, the group found.
MERCK TAKES ITS GARDASIL CAMPAIGN TO EUROPE
SARAH BOSELEY, GUARDIAN, UK - A campaign fronted by doctors and celebrities to persuade European governments, including the UK, to vaccinate all young girls against cervical cancer is being entirely funded by the drug company that markets the vaccine.
Sanofi Pasteur MSD, which markets Gardasil in Europe on behalf of the drug giant Merck, spent millions on what was billed as the "first global summit against cervical cancer", held in Paris on Thursday with doctors and patient organizations from across Europe.
The revelation comes as public health experts express disquiet about the promotion of a vaccine that is only effective in young girls - possibly at the expense of screening programs that are essential to protect adults. They also worry that the long-term effects of the vaccine are not known. The vaccine protects against the most common strains of the sexually-transmitted human papilloma virus (HPV) which causes cervical cancer.
STUDY FINDS MASSIVE PAYOFFS TO DOCTORS FROM PHARMAS
GARDINER HARRIS AND JANET ROBERTS, NY TIMES - Minnesota, [is] the first of a handful of states to pass a law requiring drug makers to disclose payments to doctors. The Minnesota records are a window on the widespread financial ties between pharmaceutical companies and the doctors who prescribe and recommend their products. . . The Minnesota records begin in 1997. From then through 2005, drug makers paid more than 5,500 doctors, nurses and other health care workers in the state at least $57 million. Another $40 million went to clinics, research centers and other organizations. More than 20 percent of the state's licensed physicians received money. The median payment per consultant was $1,000; more than 100 people received more than $100,000.
Doctors receive money typically in return for delivering lectures about drugs to other doctors. Some of the doctors receiving the most money sit on committees that prepare guidelines instructing doctors nationwide about when to use medicines. . . In dozens of interviews, most doctors said that these payments had no effect on their care of patients. . .
PHARMA FOX FINDS ANOTHER WAY INTO THE HEN HOUSE
STEPHANIE SAUL, NY TIMES - Many states, looking to rein in the cost of expensive antipsychotic drugs like Zyprexa, have turned to an unusual ally for help - the very company that sells the drug. At more than $300 for a monthly prescription, Zyprexa, which is used to treat schizophrenia and bipolar disorder, is the single biggest drug cost for state Medicaid budgets.
So Eli Lilly, the maker of Zyprexa, offers to help states monitor doctors who treat Medicaid patients to make sure they are not wasting money on mental illness drugs because of what psychiatrists call "sloppy prescribing" - giving patients too many similar medications or doses that are too high. Twenty states use Lilly's free service.
MERCK BACKS OFF OF VACCINE HUSTLE
RITA RUBIN, USA TODAY - Merck, maker of the first vaccine against cervical cancer, has decided to stop lobbying for state laws to mandate the shot as a condition of school entry, a company executive said Tuesday. Texas Gov. Rick Perry signed an executive order Feb. 2 requiring girls, beginning in September 2008, to be immunized before entering sixth grade, and at least 17 other states and the District of Columbia are considering laws to mandate the vaccine, according to the National Conference of State Legislatures.
But some vaccine proponents have raised concerns that mandating the vaccine could lead to a backlash against it. For example, the American Academy of Family Physicians on Feb. 7 issued a policy statement that said it was "premature" to consider requiring immunization for school entry. "Long-term safety with widespread use, stability of supply and economic issues" must be clarified first, the statement said. . .
GREGORY LOPES AND CHRISTOPHER M. DOLAN, WASHINGTON TIMES - Lawmakers looking to force preteen girls to take Gardasil, a new vaccine against a virus that causes cervical cancer, are targeting the wrong age group, cancer data shows. Middle-school girls inoculated with the breakthrough vaccine will be no older than 18 when they pass Gardasil's five-year window of proven effectiveness -- more than a decade before the typical cancer patient contracts the sexually transmitted human papillomavirus (HPV).
Infectious disease specialists and cancer pathologists say the incubation period for HPV becoming cancer is 10 to 15 years -- meaning the average cervical cancer patient, who is 47, contracted the virus in her 30s and would not be protected by Gardasil taken as a teen. "It is a delicate balancing act," said Debbie Saslow, director of breast and cervical cancer control at the American Cancer Society. "If the vaccine is given at too young an age, it may wear off. Yet if it is given too late, it won't work.". . .
[Your faithful journal was on Merck's case back in January when a couple of DC council members fell for the vaccine hustle. So far, the council members have neither apologized nor withdrawn their legislation]
PROGRESSIVE REVIEW CITY DESK, JAN 11 - Council members Catania And Cheh have introduced a bill that would require young girls to take a new vaccine that is claimed to prevent the sexually transmitted disease HPV, often found in cases of cervical cancer. The issue here is not whether the vaccine would work for many; the issue is the wisdom of requiring by law the use of a pharmaceutical that has only just come on the market and for which, for example, even the maker doesn't know its effect on women who take it around the time of conception. The true effects of a drug are often not realized until it's been on the market for some time. And the pharmaceutical industry has a dismal record - from indifference to outright fraud - on policing itself. Mind you, we're talking about a drug that will need to be taken in three $120 a shot doses. Consider that to this day that most people have little idea of the danger of memory loss with statins and that it took years of young people taking anti-depressants before research showed a connection with suicides. The wise move here is to provide but not require until we know much more. As the Washington Post reported, "Although the American Academy of Pediatrics recommends the vaccine for all girls ages 11 and 12, an adviser to the academy said he thought it was premature to recommend making it mandatory. 'I think it's too early,' said Joseph A. Bocchini, who chairs the academy's committee on infectious diseases. 'This is a new vaccine. It would be wise to wait until we have additional information about the safety of the vaccine.'"
PROGRESSIVE REVIEW CITY DESK - We noted the other day the foolishness of DC requiring young girls to take a vaccine to prevent cervical cancer before there was an adequate history on the drug. The vaccine in question is made by Merck and now we read in the Online Journal: "Let no one say the studies in JAMA are funded by hidden drug company money. The funding is right out in the open. 'Effects of Continuing or Stopping Alendronate After 5 Years of Treatment,' in the December 27, 2006, issue of JAMA was funded by Merck that manufactures alendronate, a bisphosphonate, under the patent name Fosamax. Not only was the study 'supported by contracts with Merck and Co.,' according to JAMA, it 'was designed jointly by the non-Merck investigators and Merck employees' and written 'with editorial input from Merck throughout the process.' Want further transparency? 'The final version of the manuscript was approved by all coauthors, including Merck authors,' says JAMA.
HOW PHARMA PHRAUD IS COVERED UP BY SECRET SETTLEMENTS
RICHARD ZITRIN, LA TIMES - Eli Lilly & Co. recently settled 18,000 lawsuits brought by people claiming they were injured by the side effects of its biggest-selling drug, Zyprexa, which is used to treat schizophrenia and bipolar disorder. But the $500 million in settlements says less about the dangers of the drug than the dangers of secrecy. About 18 months earlier, Lilly had settled 8,000 other Zyprexa cases for $700 million.
But those settlements required the plaintiffs to return all sensitive documents obtained through the legal discovery process to Lilly - a requirement that kept the strongest smoking-gun evidence out of public view. The plaintiffs also had to agree "not to communicate, publish or cause to be published, in any public or business forum or context, any statement, whether written or oral, concerning the specific events, facts or circumstances giving rise to [their] claims."
PHARMA PHRAUD MAY HAVE INCLUDED BRIBES TO SADDAM
GUARDIAN, UK - The Serious Fraud Office has launched an investigation into allegations that a number of major UK-based firms paid bribes to Saddam Hussein's regime in Iraq. The firms being targeted include the drug giants Glaxo Smith Kline, Astra Zeneca and Eli Lilly. The international oil traders and UK bridge-builders Mabey and Johnson are also to be investigated. They are on a long list of international companies accused in a UN report of paying kickbacks under the discredited oil-for-food sanctions regime, which enabled Saddam to illicitly amass an estimated $1.8bn. Ministers have agreed to fund the investigation with £22m over three years.
The investigation - the first official inquiry into the oil-for-food scandal - was urged on the British government by Paul Volcker, a former chairman of the US Federal Reserve, who compiled a UN report, delivered two years ago, into abuses of the program. . .
Mr Volcker said the kickbacks were disguised by various subterfuges. Contracts were inflated, usually by 10% to cover so-called "after-sales services" fees. More than 2,200 companies were listed, using evidence drawn from ban
LA TIMES - Casey KirkHart was in many ways a typical medical student. . . Unlike many of his peers, however, he routinely passed up the lunch that accompanied a weekly lecture, even though the food was everything a student could want: tasty, convenient and, thanks to the pharmaceutical company that catered it, free. After getting "weird looks" from peers and instructors alike, KirkHart, then at the New York College of Osteopathic Medicine, put together a Power Point presentation to explain why. Using charts and graphs, he cited studies showing that about 90% of the drug industry's $21-billion marketing budget went to physicians and that all those mugs, meals, drug samples and speakers' fees influenced doctors' prescription decisions. . .
The "pharm-free" movement he championed is spreading around the country in the wake of an article in the Journal of the American Medical Assn. challenging academic medical centers to ban drug industry freebies. . . In 2002, the industry group and the American Medical Assn. responded to rising criticism by issuing voluntary ethics guidelines. Such lavish gifts as fishing trips, expensive football tickets and greens fees at swanky golf resorts were out. Gifts had to be relatively small - pens, pads, stethoscopes - and related to patient care. Drug reps, all 90,000 of them, were urged to deliver educational programs over modestly priced lunches or dinners.
TEXAS TO REQUIRE POORLY TESTED VACCINE
[The tests on this vaccine have been mainly on older girls and women, have been short term and were sponsored by Merck]
RALPH BLUMENTHAL, NY TIMES - Texas on Friday became the first state to require all 11- and 12-year-old girls entering the sixth grade to be vaccinated against a sexually transmitted virus that causes cervical cancer.
GREGORY LOPES, WASHINGTON TIMES - The National Vaccine Information Center yesterday warned state officials to investigate the safety of a breakthrough cancer vaccine as Texas became the first state to make the vaccine mandatory for school-age girls. Negative side effects of Gardasil, a new Merck vaccine to prevent the sexually transmitted virus that causes cervical cancer, are being reported in the District of Columbia and 20 states, including Virginia. The reactions range from loss of consciousness to seizures. "Young girls are experiencing severe headaches, dizziness, temporary loss of vision and some girls have lost consciousness during what appear to be seizures," said Vicky Debold, health policy analyst for the National Vaccine Information Center. . .
Merck began marketing Gardasil last year after the Food and Drug Administration approved it for females ages 9 to 26. The vaccine is the first of its kind to build immunity against two strains of HPV, which lead to 70 percent of cervical cancer cases in the United States. . .
Its side effects were reported to the Vaccine Adverse Event Reporting System, a federal reporting system for consumers to notify federal regulators of bad reactions to medications. The adverse events began being reported in July 2006, when an advisory panel to the Centers for Disease Control and Prevention recommended girls ages 11 and 12 receive the series of shots.
PHARMA PHREE MEDICAL EDUCATION
SANDRA G. BOODMAN, WASHINGTON POST - Armed with a $400,000 grant, [Adrienne] Fugh-Berman and several Georgetown colleagues launched Pharmed Out, a free, Internet-based alternative for doctors seeking [continuing medical education courses]devoid of industry funding. The site lists more than 200 online classes available to doctors at no cost, many of them sponsored by federal agencies such as the Food and Drug Administration and the National Institutes of Health. It also includes links to studies exploring the role of drug company funding in medical education and research, as well as a You Tube interview with a former drug salesman who candidly discusses the ways he deflected doctors' concerns about a widely prescribed psychiatric drug that has been linked to massive weight gain and diabetes. . .
There is no dispute that CMEs are big business. According to the Accreditation Council for Continuing Medical Education, which oversees the courses, more than $1.7 billion was spent on CME programs in 2005, more than double the $842 million reported in 1998. About $1 billion comes from drug companies, Fugh-Berman noted in an article posted last year in Virtual Mentor, an online ethics journal published by the American Medical Association.
UNDISCLOSED SIDE EFFECTS OF THE DAY
HOUSTON BUSINESS JOURNAL - Bayer Corp. will pay $8 million to 30 states, including $200,000 to Texas, as part of a settlement requiring the company to fully disclose when drugs pose risks for patients with specific health conditions. According to the settlement, Bayer failed to adequately warn physicians, pharmacies and patients of clinical studies revealing serious consequences of taking Baycol, a cholesterol-lowering drug. The company pulled the drug from the market in August 2001 due to its muscle-weakening side effects. The terms also extend to the disclosure of clinical studies involving other Bayer drugs with possibly harmful side effects.
COALITION AGAINST BAYER DANGERS
STUDY QUESTIONS USE OF STATINS FOR THOSE WITHOUT HEART DISEASE
JOHN ABRAMSON, MD, HARVARD MEDICAL SCHOOL, AND JAMES WRIGHT, MD, BRITISH COLUMBIA, LANCET - The last major revision of the US guidelines, in 2001, increased the number of Americans for whom statins are recommended from 13 million to 36 million, most of whom do not yet have but are estimated to be at moderately elevated risk of developing coronary heart disease. In support of statin therapy for the primary prevention of this disease in women and people aged over 65 years, the guidelines cite seven and nine randomized trials, respectively. Yet not one of the studies provides such evidence.
For adults aged between 30 and 80 years old who already have occlusive vascular disease, statins confer a total and cardiovascular mortality benefit and are not controversial. The controversy involves this question: which people without evident occlusive vascular disease should be offered statins? With about three quarters of those taking statins in this category, the answer has huge economic and health implications. . .
We have pooled the data from all eight randomized trials that compared statins with placebo in primary prevention populations at increased risk. Unfortunately, our analysis is imperfect because these trials are not solely primary prevention: 8.5% of patients had occlusive vascular disease at baseline. We used two outcomes to estimate overall benefi t (benefit minus harm): total mortality and total serious adverse events (SAEs). Total mortality was not reduced by statins (relative risk 0.95, 95% CI 0.89-1.01). . .
The frequency of cardiovascular events, a less encompassing outcome, was reduced by statins. However, the absolute risk reduction of 1.5% is small and means that 67 people have to be treated for 5 years to prevent one such event. Further analysis revealed that the benefit might be limited to high-risk men aged 30-69 years. Statins did not reduce total coronary heart disease events in 10,990 women in these primary prevention trials. Similarly, in 3,239 men and women older than 69 years, statins did not reduce total cardiovascular events.
Our analysis suggests that lipid-lowering statins should not be prescribed for true primary prevention in women of any age or for men older than 69 years. High-risk men aged 30-69 years should be advised that about 50 patients need to be treated for 5 years to prevent one event. In our experience, many men presented with this evidence do not choose to take a statin, especially when informed of the potential benefits of lifestyle modification on cardiovascular risk and overall health.
ALEX BERENSON, NY TIMES - Stepping up government investigations into Eli Lilly's marketing of its best-selling drug Zyprexa, state prosecutors in Illinois and Vermont have demanded that the company turn over information about the way it promoted the medication. . . The orders are the civil equivalents of criminal subpoenas, according to Deborah Hagan, the chief of the Illinois consumer protection division.
Illinois and Vermont are now part of a coordinated five-state civil investigation into the way Lilly promoted Zyprexa, a treatment for schizophrenia and bipolar disorder. The states are investigating whether Lilly tried to hide Zyprexa's risk of causing weight gain and other risks associated with diabetes and whether the company promoted Zyprexa for use in patients who do not have schizophrenia or bipolar disorder. Federal laws prohibit such so-called "off label" marketing, although doctors may prescribe any drug for any disease that they believe the drug will help.
JOHN RUSSELL, INDIANAPOLIS STAR - Drug companies, including Indianapolis-based Eli Lilly and Co., spend lavishly to advertise drugs for insomnia, migraine headaches, dry eye, brow furrow, fungus, high cholesterol, irritable bowels, arthritis and dozens of other maladies. But the huge advertising tide, worth about $4 billion a year, might be turning as a chorus of critics accuse the drug companies of using the ads to bring consumer pressure on doctors to prescribe unnecessary and costly drugs. The industry trade association, Pharmaceutical Research and Manufacturers of America, defends the practice, saying it helps inform consumers and starts "important doctor-patient conversations about conditions that might otherwise go undiagnosed or untreated."
ONE THIRD OF BRITISH MENTAL HEALTH PATIENTS FOUND TO BE GIVEN TOO MANY DRUGS
BBC - Up to one in three mental health patients are being over-prescribed drugs, says the Healthcare Commission. A report found mental health patients were more likely to have problems with medicines than those in other trusts. . . In research undertaken by the Prescribing Observatory for Mental Health, 36% of people were found to have been prescribed more than the maximum recommended dose of anti-psychotic medicines.
http://news.bbc.co.uk/1/hi/health/6256185.stm Mental health drugs overused
HOUSE DEMOCRATS SELL OUT TO DRUG FIRMS
WASHINGTON POST - Before taking control of the House last week, Democratic leaders briefly considered proposing a new government-run prescription drug program as a way to reduce seniors' drug costs, according to Democratic aides and lawmakers involved in the deliberations. But House Speaker Nancy Pelosi (D-Calif.) and her allies chose a far less ambitious plan - to require the government to negotiate for lower Medicare drug prices . . . They stepped back largely out of concern that the pharmaceutical industry would stall a complex change, denying them a quick victory on a top consumer-oriented priority, aides say. . . Despite years of lopsidedly favoring GOP lawmakers with campaign cash and other benefits, the drug lobby continues to wield tremendous power in the Democratic-controlled Congress. . . To strengthen their position, drug firms and their trade groups have been transforming their Washington operations by hiring top Democratic lobbyists to gain access to new committee chairmen, bolstering Democratic political donations and spending millions on public relations campaigns to overcome an image, indicated in recent surveys, that the industry puts profits ahead of patients.
Even longtime industry nemeses like Rep. Fortney "Pete" Stark (D-Calif.), chairman of a House health panel, are impressed. "They're pretty potent," he said this week. "They're not bush-leaguers when it comes to spending money and lobbying."
NEW WEB SITE TO HELP DOCTORS THROUGH PHARMA PHOG
Pharmed Out, is a site designed to help physicians identify objective information and counter misleading pharmaceutical promotion practices, has been launched by Georgetown researchers. It also provides links to continuing medical education courses that are not funded by pharmaceutical companies.
"Most CME courses are funded by pharmaceutical companies, and are designed to transmit marketing messages," said Adrienne Fugh-Berman, director of the project and Associate Professor in the Department of Physiology and Biophysics. "We've identified more than 100 free, web-based CME courses, so no physician in the United States has to depend on pharmaceutical companies for education."
Pharmed Out's website, PharmedOut.org, also offers news, original videos, and links to articles, slideshows, and other materials on drug promotion, industry-sponsored research, evidence-based medicine, and many other topics.
Its video interview of an ex-drug rep describing how he sold Zyprexa (olanzapine), has already received media attention. An articles, "Doctors must not be lapdogs to drug firms", describes how pharmaceutical sales representatives walked out or threatened to withdraw educational funding from a hospital in New Mexico after Fugh-Berman spoke about how drug companies manipulate physicians. "Pharma isn't supposed to have control over the CME courses they fund," says Fugh-Berman. "But they do. It's an unspoken agreement; conference organizers understand that speakers must not say anything critical of pharmaceutical companies."
Plans for the project include live CME courses for physicians and physicians-in-training courses, and a series of articles and film clips designed to increase awareness about pharmaceutical marketing techniques.
Pharmed Out is funded through the Attorney General Consumer and Prescriber Education grant program, created as part of a 2004 settlement between Warner-Lambert, a division of Pfizer, Inc., and the Attorneys General of 50 States and the District of Columbia, to settle allegations that Warner-Lambert conducted an unlawful marketing campaign for the drug Neurontin (gabapentin) that violated state consumer protection laws.
WHAT HAPPENED WHEN A DOCTOR SPOKE OUT ON THE INFLUENCE OF THE DRUG INDUSTRY ON MEDICAL EDUCATION
ADRIANE FUGH-BERMAN, BRITISH MEDICAL JOURNAL - Last month I gave a talk at Presbyterian Hospital in Albuquerque, New Mexico, about the influence of the drug industry on continuing medical education. As usual, pharmaceutical companies contributed funds to the conference, and there was a small exhibition area with the usual monopoly of drug firms.
Immediately after my talk, one pharmaceutical company representative announced to a conference organizer that her company would no longer support the annual conference. Another packed up his exhibit and walked out. Other drug representatives were observed muttering angrily into their cell phones, which may, or may not, have been related to the near total exhibitor boycott the next day. Only one exhibitor showed up, prompting a physician friend of mine to remark, "Maybe he missed your talk.". . .
The organizers arranged a debate with a sales representative on whether pharmaceutical companies should fund continuing medical education for physicians. The drug representative who agreed to the debate later backed out on the advice of "legal." Despite having been offered equal time, this is the same person who announced that her company would not support future conferences. . .
The audience of physicians, nurses, and allied health professionals seemed immensely interested-and acutely aware of the rarity of an occasion in which the relationship between medicine and the drug industry was questioned. Several physicians noted on their comment forms that the organizers were brave to address the subject. Some delegates even offered to pay higher registration fees in the future to offset the drug firms' defection. . .
Corporate support of continuing medical education courses, meals, and treats are not merely our just rewards for being hardworking, dedicated doctors. The illusion that the relationship between medicine and the drug industry is collegial, professional, and personal is carefully maintained by the drug industry, which actually views all transactions with physicians in finely calculated financial terms. Drug representatives are paid to be nice to us, as long as we cooperate, sustaining our market share of targeted drugs and limiting our continuing medical education lectures to messages that increase drug sales. This is an unspoken agreement, but no less clear for being covert.
The drug industry is happy to play the generous and genial uncle until physicians want to discuss subjects that are off limits, such as the benefits of diet or exercise, or the relationship between medicine and pharmaceutical companies. Any subject with the potential to reduce drug sales is anathema. Fair enough. He who pays the piper calls the tune. If we remain dependent on pharmaceutical companies for sponsoring continuing medical education, then these courses will remain under the control of the drug industry. This control is not contractual, but it is enforced through psychological manipulation.
If corporate sponsorship of medical meetings is deemed indispensable, why limit sponsorship to pharmaceutical companies? Surely the manufacturers of cars, luggage, and travel services would pony up for the opportunity to sell their goods to physicians. Conference organizers could solicit sponsorship from firms that market practice management software, office furniture, or other business related goods. As a last resort, we physicians could actually pay for our continuing education, as do lawyers, accountants, business people, and aerobics teachers, to mention a few. Medicine must shed both its docility and the corporate leash. Let us not be a lapdog to the pharmaceutical industry. Rather than sitting contentedly in our master's lap, let us turn around and bite something tender. Freedom calls. The drug industry is happy to play the genial uncle until physicians want to discuss subjects that are off limits
PHARMA PHRAUD: ELI LILLY USED SCARE TACTICS TO PROMOTE DRUG
RICHARD KNOX, NPR - Drug maker Eli Lilly & Co. used questionable marketing practices to promote its drug to fight blood infections, according to several doctors. A whistleblower report in the New England Journal of Medicine accuses the company of initiating false reports of a shortage of the drug, Xigris. The plan involved a public-relations firm hired by Eli Lilly, which then spread the word that its very expensive drug was being "rationed," the report says. It also included descriptions of physicians being "systematically forced" to decide who would live and who would die.
Xigris was designed to fight sepsis, a condition that kills more than 200,000 Americans annually. It is the only approved drug for sepsis, and it costs $8,000 to treat a single patient. Lilly hoped it would be a blockbuster, with sales of at least a billion dollars a year. But after five years on the market, sales are only $200 million.
That led the company to take unusual steps, according to Dr. Robert Danner, an infectious-disease expert at the National Institutes of Health. Danner emphasizes that in this case, he is speaking as a private citizen, not an NIH employee.
Danner says Lilly hired a P.R. firm that created the message that doctors were being forced to ration Xigris because of its high cost. That message was promoted by a newly formed task force on ethics. Lilly funded the task force with $2 million.
Next, a group of physicians, many with financial ties to Lilly, founded the Surviving Sepsis Campaign. Lilly provided the great majority of the funding. The campaign's first task was to formulate new practice guidelines for treating sepsis.
At least 11 medical groups endorsed the new guidelines. But the influential Infectious Diseases Society of America did not.
Dr. Naomi O'Grady chaired the panel of the Infectious Diseases Society that reviewed the guidelines. "Let me choose my words carefully," said O'Grady, who is not involved with the current report. "This guideline really, I believe, was designed to promote a product.". . .
MORE PHARMA PHRAUD CHARGED IN 6,000 LAWSUITS
USA TODAY - More than 6,000 lawsuits have been filed in recent years against four drugs taken by millions of patients: hormone-replacement drug Prempro, birth-control patch Ortho Evra, anti-psychotic Seroquel and anti-seizure drug Neurontin.
The plaintiffs claim drug makers failed to disclose the drugs' risks or failed to properly test them, or both. The claims are similar to those against Merck's painkiller Vioxx, which faces 14,000 lawsuits. Unlike Vioxx, these drugs are still being sold, and the Food and Drug Administration considers their benefits worth their risks. . .
The lawsuits raise questions about whether drugmakers and the FDA pay ample attention to patient safety. Since 2000, more than 65,000 product liability lawsuits have been filed against prescription drugmakers, the most of any industry, says researcher Thomson West.
DRUG CORPORADOS FUND OVER HALF OF CONTINUING MEDICAL EDUCATION
ADRIANE FUGH-BERMAN, MD, AND SHARON BATT, VIRTUAL MENTOR ETHICS JOURNAL OF THE AMA - A recent proposal to address conflicts of interest in academic medical centers suggested that industry support of continuing medical education activities should be limited to contributions to a central fund that would disburse the money to programs accredited by the Accreditation Council for Continuing Medical Education. . .
Medicine is a profession, and pharmaceutical marketing is a business. The obligation of physicians is to patients; the obligation of a pharmaceutical company is to shareholders. The interests of medicine and pharmaceutical manufacturers are not congruent. The collegial relationship between the two would undoubtedly cool were physician signatures not a prerequisite for prescription drug sales. Physicians are considered by the industry to be a barrier to surmount. . .
Gifts have been shown to create obligations. Indebtedness to pharmaceutical manufacturers as an industry rather than to individual companies merely renders the obligation less visible-and more decorous, perhaps. It is in the interests of all pharmaceutical companies to engage in disease mongering by expanding diagnostic categories so more people are eligible for drug treatment and to convince physicians that drugs are the only viable therapeutic options.
While physicians who receive [Continuing Medical Education] funded by a corporate coalition [which pools contributions] may not be subjected to presentations promoting specific drugs, the "Drugs-R-Us" model of medicine is still reinforced. Diet, exercise and other non-pharmacologic approaches to disease prevention and treatment will continue to be marginalized. . .
Pharmaceutical company-sponsored CME is designed to increase the receptivity of physicians to prescribe more of a target group of drugs. It is then up to the sales staff of competing drug companies to determine the market share of drugs within that group. Rather than attempting to devise ethical ways for physicians to maintain their dependence on industry-funded CME, it is time to search for true alternatives. The education of physicians should be funded by physicians, not by a third party whose profits are directly related to prescribing behavior.
Weaning CME from the industry breast is like striving to meet our energy needs without oil-tough but necessary. The presumption that pharmaceutical manufacturers' funds are necessary for CME permeates medical culture. The AMA itself takes industry funds. In 2000, in what Carl Elliott has called a "stunningly inept" decision, the AMA accepted pharmaceutical company co-funding for a campaign to provide doctors with ethical guidelines regarding gifts from industry. In 2004, more than $2 billion was spent on CME; pharmaceutical manufacturers paid for more than half of that sum. Firms that manufacture FDA-regulated products (primarily pharmaceuticals) provided three-quarters (74.7 percent) of the income of medical education and communication companies.
CME provided by medical schools is almost equally reliant on the pharmaceutical industry, which provides almost two-thirds (63.8 percent) of CME income to medical schools. . .
Pharmaceutical companies have good reason to value CME. A 2004 survey of 4,600 physicians, conducted by Verispan, found that educational seminars ranked highest in effective sales tactics. A smaller industry poll of 237 physicians in the fall of 2005 also found that physicians (at least those attending CME events where the survey was done) rated CME to be their most valued information source, followed closely by medical journals and peer interaction.
PHARMA PHRAUD: HOSPITALS IN CAHOOTS WITH DRUG FIRMS
WALT BOGDANICH, NEW YORK TIMES - One recent sun-splashed afternoon, executives who run some of America's leading nonprofit hospitals met at a stately Colorado resort for an unusual mission: to advise companies confidentially on how best to sell their drugs, medical devices and financial services to hospitals. The hospital executives were rewarded with more than a chance to indulge in a "harmonic" hot stone massage or mountainside golf.
They were also paid thousands of dollars for the advice they offered to dozens of companies, like Eli Lilly, Johnson & Johnson, Morgan Stanley and Citigroup. The hospital officials and their spouses received a free trip to the luxury resort, where they could join the Morgan Stanley Tennis Tournament or the GE Healthcare Barbecue. All of this came courtesy of the Healthcare Research and Development Institute, a for-profit company that is owned by about three dozen hospital executives, but underwritten by 40 or so of its handpicked corporate members, all suppliers to hospitals.
MEDICAL JOURNAL GETS CONNED AGAIN BY AUTHORS WITH PHARMA TIES
SEATTLE POST-INTELLIGENCER - For the second time in two months, the Journal of the American Medical Association says it was misled by researchers who failed to reveal financial ties to drug companies. The studies' validity - and the prestigious journal's reputation - are at stake, and JAMA is tightening its policies for researchers as a result. . . The latest incident, disclosed in letters to the editor and a correction in Wednesday's journal, involves a study showing that pregnant women who stop taking antidepressants risk slipping back into depression. Most of the 13 authors have financial ties to drug companies including antidepressant makers, but only two of the them revealed their ties when the study was published in February.
PHARMA PHRAUD TO GAIN FROM OBESITY OBSESSION;
OVERWEIGHT KIDS MAY BE HURT
BRITISH MEDICAL JOURNAL - New guidelines on obesity in the US may end up harming children, says an article in this week's BMJ. And an accompanying article goes on to question the financial links between the organization promoting these proposals and the pharmaceutical industry. If implemented, the proposals would see many more children classified as overweight or obese - and thus eligible for treatment with obesity drugs.
The article outlines how an influential expert committee of the American Medical Association has "tentatively decided" to reclassify obesity definitions. This will result in healthy children being categorized as medically overweight or obese, says the author, and mean that approximately a quarter of toddlers and two fifths of children aged 6-11 in America will be classed as having the disease.
Author of the articles is Ray Moynihan, who has previously written about drug companies promoting an increasing reliance on medications to the public. His report reveals that the US proposals have been greeted with alarm by some senior public health academics who have written to the committee. Dr Jenny O'Dea from the University of Sydney, for instance, warned that labeling children as overweight or obese can lead to stigmatization, eating problems, and avoidance of exercise.
Mr Moynihan points out that one of the prime movers behind the proposed changes being considered by the expert committee is Dr William Dietz, a senior member of the International Obesity Task Force. In the second article Mr Moynihan reveals how the high profile and highly influential Task Force, which has close ties to the World Health Organization, was set up in the mid-1990s with the help of grants from three drug companies and continues to benefit from drug company sponsorship.
Now merged with another international obesity forum, the Task Force gets two thirds of its funding from pharmaceutical giants Roche and Abbott. Roche makes the anti-obesity drug Xenical (orlistat), and Abbott makes the appetite suppressant Reductil (sibutramine hydrochloride). Over recent years, the article states, drug company sponsorship is likely to have amounted to "millions".
The Task Force has responded to Mr Moynihan's questions about its funding, saying that it has made no secret of the grants it has received from drug companies and emphasising that an internal ethical scrutiny system ensures independence from sponsors.
SUBTLE WAYS THE PHARMA-CORPS MANIPULATE YOUR HEALTH CARE
ADRIANE FUGH-BERMAN MD, NATIONAL WOMEN'S HEALTH NETWORK - If you're handed a laptop at your doctor's office to type in your medical information, don't use it - unless you don't mind your personal medical information being sent straight to a pharmaceutical company. Phreesia, a New York company, distributes wireless "WebPads" that patients use to input medical histories and other information, including why they're seeing the doctor. A 2005 Phreesia press release states, "After completing the interview patients are directed to a health education portal where they are able to read targeted material about their health that reduces their perceived wait time.". . .
The company's website notes that: "Phreesia partners with pharmaceutical and medical device companies to provide sponsored content to patients before they see their physician often stimulating conversation and helping to educate patients on health issues relevant to their visit."1 Subtle advertising isn't the only way pharmaceutical companies benefit.
Your doctor gets an electronic copy of your health questionnaire, but so does the pharmaceutical (or medical device) company, which uses the information for marketing purposes. And no, that's not illegal, because patient names are stripped from the questionnaire before being transmitted to the sponsoring company. Your doctor gets the opportunity to "code higher," which means choosing a diagnosis that reimburses more from insurance companies.
Drug and device companies have invaded waiting rooms in other ways as well. A company called The Healthy Advice Network has installed silent TVs permanently tuned to a mixture of drug ads and health news in 95,000 waiting rooms across the U.S. Customized messages can be included or certain advertisements blocked. Healthy Advice tells physicians that any specific ads can be removed from the content with "no questions asked."
Does your doctor have a web site? It may be a present from Big Pharma as a way to gather information about patients, coax consumers to visit web sites and increase their demand for specific drugs, and increase doctors' receptivity to visits from drug reps. Health Banks is one company that develops web sites customized to doctors' practices and/or specific diseases. (Other companies that offer web sites to physicians include Amicore, a joint venture by Pfizer, IBM, and Microsoft; MyHealth.com, from Schering-Plough; and MyDocOnline, from Aventis.) These Big Pharma-sponsored sites are made available through the companies' drug reps, a ploy to provide "a compelling role for pharmaceutical sales representatives."
Big Pharma sponsors use the web sites to collect information about the concerns of specific practices' clients. Sharing this information with doctors provides drug reps with more face time with physicians. But doctors aren't the only ones getting this information. HealthBanks collects data on the interests of the sites' users and shares that with the pharmaceutical companies that fund the web sites. HealthBanks' chief executive officer has stated: "Helping make the health information connection between the prescriber and the patient is the big opportunity for pharmaceutical companies today. In addition to becoming a valuable contributor to the health care process by supporting a physician-to-patient channel, pharmaceutical companies will also benefit by gaining proprietary access to aggregate data about physician and patient behaviors, questions, opinions, and preferences." . . .
HOW MANY WAYS IS THE DRUG INDUSTRY CONNING YOU?
DEAN BAKER, TRUTHOUT - The New York Times had an excellent story this week about how drug and medical supply companies make large contributions to charitable foundations run by physicians. To the casual observer, these contributions look like kickbacks, given in exchange for doctors writing prescriptions for their products and also publishing favorable research findings.
This is not the first instance of corruption in the prescription drug industry. The stories of corruption in the drug industry could fill the Manhattan phone book. For starters, this is not the first time the industry has been associated with kickback schemes. It used be standard practice to hold expense-paid "seminars" at lavish vacation resorts. Of course, there also have been instances of straight out bribes to prescribe the right drugs.
The research process has also been corrupted. The industry frequently pays prominent researchers to submit journal articles that were drafted in the company's PR office touting the benefits of their drugs. In their own research, drug companies will often attempt to conceal evidence that their drugs are ineffective or even harmful, as is alleged in the Vioxx lawsuits.
The industry's efforts to buy political influence with campaign contributions and lobbyists are well-known. The Medicare prescription drug benefit costs twice as much as was necessary because the industry got Congress to structure the bill to ensure hefty profits for drug companies, instead of affordable drugs to seniors. . .
DRUG COMPANIES USING WORLD'S POOR FOR UNREGULATED TESTING
KELLY HEARN, ALTERNET - A newly surfaced report alleges that in 1996, drug monolith Pfizer gave an unproven drug to Nigerian children and infants suffering from meningitis -- without the authorization of the Nigerian government. Completed five years ago and coming to light in a May 7 Washington Post investigation, the confidential report, written by a panel of Nigerian health experts, concluded that administering the drug Trovan to 100 patients suffering a deadly strain of meningitis was "an illegal trial of an unregistered drug." The drug was ultimately shown to be ineffective. A lawsuit against Pfizer claims some of the children in the trial died and others suffered brain damage.
The report surfaces as more and more clinical research relocates to the global south in order to escape burdensome regulation schemes in the United States and Western Europe. AlterNet has obtained an early look at a book to be published later this year -- The Body Hunters: How the Drug Industry Tests Its Products On the World's Poorest Patients (New Press), by investigative journalist Sonia Shah -- that raises the curtain on a trend that's harming patients and health care systems while eroding the developing world's trust in conventional medicine.
Researchers needing patients and freer working conditions have for years found a honey pot in the world's slums and shantytowns. The fact that poor, desperate patients are willing to try anything, means companies like GlaxoSmithKline, Merck and Wyeth currently conduct 30 percent to 50 percent of their experiments outside Western Europe and the United States, and plan to boost foreign trials by 67 percent this year, according to USA Today. Their urgency is understandable; Shah's book notes that to get a single drug to market, drug companies are forced "to convince more than 4,000 patients to undergo 141 medical procedures each in more than 65 separate trials."
THE HIDDEN DANGERS OF TYLENOL
57% OF PUBLISHED DRUG STUDIES IN PSYCH JOURNALS FUNDED BY COMPANIES WITH EXPECTABLE RESULTS
MARILYN ELIAS, USA TODAY - Drug companies fund a growing number of the studies in leading psychiatric journals, and drugs fare much better in these company-funded studies than in trials done independently or by competitors, researchers reported Wednesday. About 57% of published studies were paid for by drug companies in 2002, compared with 25% in 1992, says psychiatrist Igor Galynker of Beth Israel Medical Center in New York City. ..
There were favorable outcomes for a medication in about:
o Eight out of 10 studies paid for by the company that makes the drug.
o Five out of 10 studies done with no industry support.
o Three out of 10 studies done by competitors of the firm making the drug.
The findings don't prove the companies are knowingly biasing studies, says co-author Robert Kelly Jr., also with Beth Israel. The report didn't look at the evidence for bias in design of the studies.
DRUG COMPANIES CREATING NEW DISEASES TO SELL PRODUCTS
MARK HENDERSON, TIMES, UK - Pharmaceutical companies are systematically creating diseases in order to sell more of their products, turning healthy people into patients and placing many at risk of harm, a special edition of a leading medical journal claims.
The practice of "disease mongering" by the drug industry is promoting non-existent illnesses or exaggerating minor ones for the sake of profits, according to a set of essays published by the open-access journal Public Library of Science Medicine.
The special issue, edited by David Henry, of Newcastle University in Australia, and Ray Moynihan, an Australian journalist, reports that conditions such as female sexual dysfunction, attention deficit hyperactivity disorder and "restless legs syndrome" have been promoted by companies hoping to sell more of their drugs.
Other minor problems that are a normal part of life, such as symptoms of the menopause, are also becoming increasingly "medicalized", while risk factors such as high cholesterol levels or osteoporosis are being presented as diseases in their own right, according to the editors.
"Disease-mongering turns healthy people into patients, wastes precious resources and causes iatrogenic (medically induced) harm," they say. "Like the marketing strategies that drive it, disease-mongering poses a global challenge to those interested in public health, demanding in turn a global response." . . .
PHARMA PHRAUD: STUDY RESULTS REFLECT FUNDERS' DESIRES
SHANKAR VEDANTAM WASHINGTON POST - Pharmaceutical giant Eli Lilly and Co. recently funded five studies that compared its antipsychotic drug Zyprexa with Risperdal, a competing drug made by Janssen. All five showed Zyprexa was superior in treating schizophrenia. But when Janssen sponsored its own studies comparing the two drugs, Risperdal came out ahead in three out of four. In fact, when psychiatrist John Davis analyzed every publicly available trial funded by the pharmaceutical industry pitting five new antipsychotic drugs against one another, nine in 10 showed that the best drug was the one made by the company funding the study. "On the basis of these contrasting findings in head-to-head trials, it appears that whichever company sponsors the trial produces the better antipsychotic drug," Davis and others wrote in the American Journal of Psychiatry.
Such studies make up the bulk of the evidence that American doctors rely on to prescribe $10 billion worth of antipsychotic medications each year. Davis pointed out the potential biases in design and interpretation that produced such contradictory results. Other experts note that industry studies invariably seek to boost the image of expensive drugs that are still under patent. Moreover, they say, the trials are relatively brief and test drugs on patients with simpler problems than doctors typically encounter in daily practice.
FDA TRIPS PAID FOR INDIRECTLY BY COMPANIES IT REGULATES
PR WATCH - The U.S. Food and Drug Administration policy that precludes employees from accepting trips paid for by companies the agency regulates is easily side-stepped. Alexander Cohen reports that non-profit groups that "draw their members, their boards and even some of their funding from medical and pharmaceutical-related companies" paid for roughly one-third of the 3,600 sponsored trips received by hundreds of FDA employees since 1999. "The sponsor of the most trips was the Drug Information Association, which footed the bill for more than 600 trips taken by FDA employees," Cohen reports. Employees of The Weinberg Group, a PR company which boasts that it helps to defend clients "products in the courts and the media", have close ties to the DIA. One of its employees delivered a presentation to last years DIA annual meeting titled "FDA Enforcement: What You Need to Know to Avoid or Respond to the FDA."