Archive for February, 2010

Bayer bluewashes its image. Bayer’s corporate crimes.

Sunday, February 28th, 2010
 

Bayer and the UN Global Compact

How and Why a Major Pharmaceutical and Chemical Company “Bluewashes” its Image
by Philipp MimkesCoalition Against Bayer Dangers
July 19th, 2002

 
Bayer Hazard. Photo: Totnes Genetix Group (ToGG)
 Totnes Genetix Group (ToGG)

 

Bayer considers itself a “founding member” of the UN Global Compact, but its dedication to the Compact’s nine human rights and environmental principles should be seen in the context of an extremely controversial corporate history. Some of that history is outlined in this article by Philipp Mimkes of the Coalition Against Bayer Dangers (CBG). CBG has found that Bayer has been using its “membership” in the Compact to deflect criticism by watchdog groups, without addressing the substance of the criticism. Bayer’s use of the Global Compact is a classic case of “bluewash” — using the good reputation of the United Nations to present a corporate humanitarian image without a commitment to changing real-world behavior.

RELATED DOCUMENTSWhy Bayer’s Corporate Image May Need a Face Lift

When most of us hear the brand name “Bayer” we think of aspirin. But Bayer AG, based in Leverkusen, Germany is a major producer of chemicals, pharmaceuticals, pesticides, and plastics. The company employs 120,000 people worldwide and its annual sales are some $28 billion. The U.S. is its largest market, and the company has facilities in Mexico, Brazil, South Africa, India, Thailand, China, Japan and many European countries. It is also a founding member of the UN’s Global Compact, a partnership between the United Nations and big business. Bayer has signed on to nine voluntary, non-binding human rights and environmental principles. In exchange for the use of the UN name and logo, a range of UN programs hope to receive funding from giant corporations.

A Few of Bayer’s Corporate Crimes

Bayer has a long history of giving profits precedence over human rights and environmental concerns. During the First World War the company invented Chemical Warfare (“moisture gas”) and built up a “School for Chemical Warfare.” Thirty years later Bayer was part of the conglomerate IG Farben, which worked closely with the Third Reich. IG Farben exploited several hundred thousand slave workers at their plant in Auschwitz. It also took over companies throughout Europe and used human guinea pigs for pharmaceutical research. IG Farbens subsidiary Degesch manufactured Zyklon B, the poison gas used in the gas chambers. In the late 1930’s organophosphates (sarine, tabun) were introduced, after the war marketed by Bayer as pesticides (E 605, Folidol, Nemacur, Fenthion). IG Farbens managers were convicted as war criminals at the Nuremberg Trials. After the war Farben was broken up into BASF, Bayer and Hoechst (now called Aventis), and the three firms still cooperate closely and exert a large influence on German and European politics.

Corporate Lobbying

Bayer also leverages its economic clout in the political arena. Since the 1920’s the company has financed German political parties and several Bayer managers became ministers in German governments. Today, Bayer is a member of hundreds of lobby groups tackling ‘trade barriers’ like environmental or health and safety laws. The European Round Table of Industrialists effectively writes big chunks of EU corporate legislation. Bayer also helped set up the Transatlantic Business Dialogue, where European and US multinationals work together to influence policy in the direction of greater liberalization and deregulation. Other lobby groups that Bayer takes an active role in are the International Chamber of Commerce, the Global Crop Protection Federation and the German Verband der Chemischen Industrie and Bundesverband der Deutschen Industrie. Bayer supported President Bush’s electoral campaign with $120,000. In the last five years Bayer has handed out more than $600,000 to US politicians.

Founding Member of UN Global Compact

Two of IG Farbens successors — Bayer and BASF — signed onto the Global Compact at its founding meeting in July 2000. Bayer advertises its cooperation with the UN broadly, for example by printing an editorial by Secretary-General Kofi Annan in its “Sustainable Development Report.” The company’s website and Annual Report dedicate special section to the Global Compact.

To document its commitment to the principles of the Compact the firm touts four examples:

  • Its financial support for the Brazilian Abrinq Foundation for the Rights of the Child, which combats child labor.
  • Donations of two pharmaceutical products against sleeping sickness to the World Health Organisation.
  • Its efforts to control the spread of antibiotic resistance.
  • And company training programs for Brazilian farm workers and small farmers teaching them to handle pesticides appropriately.

In addition, Bayer provided medicines after earthquakes in India and El Salvador and donated one million dollars and fire-fighting equipment to relief organizations following the September 11th attack on the World Trade Center.

Bayer does not publish figures on its efforts to combat child labor in Brazil or its contributions to the WHO, but the Coalition Against Bayer Dangers has learned that these expenditures are less than $1 million each.

At the same time as these comparatively modest contributions, the taxes Bayer paid declined from about $1 billion in 2000 to $132 million in 2001. The tax cuts added up to more than fifty times the company’s total philanthropic donations. Even assuming Bayer’s donations all go to worthy causes, the public might be far better off foregoing Bayer’s contributions in favor of their paying taxes.

Case Study: Initiative “Agrovida”

Bayer is the third biggest manufacturer of herbicides globally, and dominates the insecticide market. Insecticides are responsible for the majority of pesticide poisoning in countries in the Global South. The World Health Organization annually counts 2 million pesticide poisonings and estimates that the number of unreported cases is probably higher than 10 million. About 200,000 people per year die from pesticide poisonings, according to the WHO.

In 1995 Bayer promised to withdraw its most toxic pesticides, but has yet to do so, and still sells pesticides rated by the WHO as ‘extremely’ or ‘highly’ hazardous. Bayer claims that it is the responsibility of pesticide users to take precautions, despite the fact that underpaid farm laborers often do not have access to health and safety information.

To “minimise the risks to humans and the environment” Bayer in Latin America has started the initiative “Agrovida.” Several thousand people in the rural farming region in southern Brazil were trained in what the company considers safe pesticide use. According to Bayer the program is geared towards sustainable farming. “The crop protection part of this strategy concentrated on the safety of the user, proper storage of crop protection products, maintenance of equipment, and careful disposal of empty containers,” notes the corporation. The company admits that “the training campaign was perhaps only a small step in terms of the area it covered, but it was certainly a forward-looking step if one considers what an excellent model it could be for other regions of the world”.

Training “several thousand people” might be helpful, but the fact remains that millions of farmers in countries who use Bayer’s highly toxic products have never received any instructions. Bayer regularly breaches the Food and Agriculture Organisation (FAO) code of conduct — which it has signed — stipulating which pesticides should only be sold to certified professionals who wear full protective clothing, and not to the general public.

Even Brazil, where Agrovida is based, Baysiston, the number one pesticide on the market, has poisoned hundreds of coffee growers, at least 30 of them fatally. The omnipresent advertising of Baysiston camouflages the risks. Many coffee growers even believe Baysiston to be a fertilizer which increases yields. The State Prosecutor who investigated the case complained about the publicity which presents the product as harmless, ignoring its potential risks. Bayer stated that the company is aware of cases of Baysiston poisoning, but that these cases were not due to lack of information but to “inexpert use alone.”

Following reports in the German and Brazilian news media, the company pressured local governments and medical doctors to collude in minimizing concerns about their products risks. The firm threatened to sue communities which intended to limit the use of Baysiston. (Some municipalities went ahead with measures nevertheless.) Bayer contacted hospitals to warn them not to blame “Baysiston intoxication,” or even “pesticide poisoning” on official death certificates. Later on, the company donated money to a group of doctors who would cooperate with its cover up. According to the Brazilian Agricultural Worker’s Union, Baysiston poisonings continue daily but rarely appear in the records.

Case Study: Antibiotics and Resistant Bacteria

Bayer is a major producer of antibiotics, including the fluoroquinolones Cipro for humans and Baytril for animals. The effectiveness of many life-saving antibiotics is, however, waning. Health experts have deemed the rise in antibiotic resistance a public health crisis. Bayer pretends to counter the problem by starting a new initiative which “aims to work with leading health organizations and experts to help tackle the growing threat caused by bacteria rapidly developing resistance to today’s antibiotics, a serious problem affecting developing countries as well as industrialized states.”

Bayer also touts its membership in the Global Compact as motivation for the program. “Since Article 25 of the Universal Declaration of Human Rights (UDHR) states that everyone has the right to a standard of living adequate for the health and well being of himself and of his family, the project is perfectly in line with the Global Compact Initiative and its aims.”

But in reality Bayer’s business activities themselves are contributing to the rise of resistant bacteria: a major reason for resistence is feeding antibiotics unnecessarily to healthy farm animals to promote growth and to compensate for unsanitary conditions. The Union of Concerned Scientists estimates that 70% of all antibiotics in the U.S. are used in healthy pigs, poultry and cattle. Because fluoroquinolones are given to entire flocks indiscriminately in their drinking water, near-ideal conditions for speeding the development of resistance are created. The American Medical Association has publicly demanded a stop to the use of antibiotics in agriculture for healthy animals.

In October 2000, the US Food and Drug Administration (FDA) proposed banning fluoroquinolone antibiotics for treating poultry. FDA scientists asserted that the antibiotic’s use in chickens and turkeys has sped the development of fluoroquinolone-resistant Campylobacter. FDA estimates that Campylobacter contaminates up to 80 percent of broiler chickens in some supermarkets. The medical community strongly supported FDA’s proposal, as did the public interest community. Abbott Laboratories, maker of one fluoroquinolone product for poultry, complied with FDA’s proposal, withdrawing the product from the market.

However, Bayer Corporation, the sole remaining manufacturer, has demanded a formal hearing, a process that is likely to take years to complete. Physicians fear that if the ban is delayed, and Campylobacter bacteria continue building resistance at current rates, the problem may become moot.

Greenwashing and the Global Compact

Bayer has a long tradition in greenwashing: the company has actively promoted terms like “crop protection” instead of “pesticides,” and has embraced “Sustainable Development” and “Responsible Care.” Across the world the company promotes the idea of non-binding voluntary commitments to solve environmental problems.

In the past year journalists or concerned citizens who criticized Bayer’s record, were routinely referred to Bayer’s commitment in the Global Compact.

For example, the Washington DC-based Multinational Monitor magazine put Bayer in their list of “The Ten Worst Corporations of 2001.” They included the company for several reasons: Bayer’s behavior in the anthrax crisis, when the company tried to sell overpriced antibiotics to the American government; the withdrawal of the cholesterol-reducing drug Lipobay/Baycol which had led to the death of at least 100 patients; the suit against the watchdog group, Coalition against Bayer Dangers, for maintaining a BayerWatch.com website (the site is now used by the Campaign Against the Overuse of Antibiotics); and Bayer’s refusal to pull Baytril from the market.

After several German newspapers carried the Ten Worst Corporations story, Bayer issued a statement rejecting the Multinational Monitor’s charges. “Multinational Monitor is the organ of an alliance of activist groups that have the common aim of criticizing companies,” according to Bayer which singled out the Coalition Against Bayer Dangers. “Bayer is one of the founding members of the UN Global Compact of UN Secretary Kofi Annan, that was started in July 2001. Therein the company obliges itself to agree with and spread nine principles the UN picked in the fields of human rights, social standards and environmental protection,” the statement emphasized.

Bayer did not respond to any allegations but instead attacked their critics, say activists. The Coalition against Bayer Dangers has been sued by Bayer several times. In a spectacular case which dragged on for five years, the German Supreme Court ruled in favor of the watchdog group.

For more information on Bayer’s record visit:
www.CBGnetwork.org
www.BayerWatch.com
www.BayerHazard.com

To receive the free English newsletter Keycode Bayer please send an email to: CBGnetwork@aol.com

Philipp Mimkes is with the Coalition Against Bayer Dangers in Germany

Comments on fluoroquinolone toxicity by LG Lindsay, a Levaquin victim.

Friday, February 26th, 2010

Comments posted by LG Lindsay:

 
Fluoroquinolone (FQ) research articles are written in technical language that is gibberish to lay people who are not schooled in biochemistry, the genome and in molecular engineering.  Further, professional-grade research articles are generally available online only from fee-based medical research clearing houses.  Accordingly, FQ-poisoned “floxies” are screwed on both counts.  Firstly, a floxie cannot describe or fathom the nature of quinolone toxicity syndrome (QTS) because s/he is not conversant with its technology and mechanism of poisoning, and cannot articulate QTS in syntax that is understandable and acceptable to front-line medical practicioners. Secondly, even if a floxie could decrypt the technology, a floxie would have to roll the dice and hunt with his/her checkbook to find a for-fee research article that pertains to QTS. It’s the proverbial hunting for a needle in the haystack.  Separately, there is an economic disincentive that stifles profit-seeking pharmaceutical companies from making any disclosure whatsoever that might adversely effect sales. Pharmaceutical research, development and marketing survives as an on-going enterprise in an economic system that takes no prisoners. In this regard big pharma is no different than other legal corporate entities whose duty lies with increasing their shareholders’ larder while limiting their  liability.  It’s that simple. Short of a clear, verifiable test by which a causal chain can be established between FQs and QTS — whose causality is clear on its face to plumbers, butchers and candlestick makers —- QTS will continue to rumble through unopposed and occasionally wreak havoc with  the sick and medicated.  There’s really no stopping it unless floxies can enlist the help of biochemical, genetic and molecular researchists who can explain succinctly FQ technology and its downside association with QTS.

You know the drill.  Daily we scroll through dozens or hundreds of on-line articles of unknown quality that are written in specialized, arcane language of technologists.  Someone pays for generating these research articles.  It’s NOT floxies who originate and underwrite FQ research.  We’re not really sure who underwrites FQ researchists whose identities and motivation are hidden beneath soporific, sophmoric and vaguely reassuring nonprofit names that are reminiscent of lobbying firms on “K” Street in Washington, DC that routinely advocate legislation to legitimate their clients’ inalienable right for succor and liability-free profits.

And, so, we remain thirsty patients drilling frantically through scientific bolsons that remain just out-of-reach on the internet.  We pray to wrest a few drops of moisture from medical aquifers whose salvation and knowledge remain hidden deep underground and seemingly impregnable to our blunt drill.

I offer exhibit “A” (below) or  ”how I tried to penetrate fee-free research into the effects of fluoroquinolones upon dogs.”  Yup, that’s right, how FQs adversely effects canines.  It’s the only research I found that I vaguely could understand.  I’m not sure whether it says a lot about me, about dogs, about the pharmaceutical industry or about pharma-researchists.  But it says a lot about the human condition.  
    

“A Fluoroquinolone Induces a Novel Mitogen-Encoding Bacteriophage in Streptococcus canis”

Kindly enter the URL http://ukpmc.ac.uk/articlerender.cgi?artid=330783
and witness how FQs induce a  new way to unleash chemical messengers that trigger cell division among proteins in viruses that, in turn, infect and destroy bacteria. (See the researchists’ discussion below.***)  So, here’s how it works: The guy in a white lab coat chemically tricks viruses to grow and multiply and then invade and kill bacteria cells.  But wait, according to the above-ref. article the FQs sometimes induce “recognized emergence of canine streptococcal toxic shock syndrome (STSS) and necrotizing fasciitis (NF).” Holy shit!  After Dr. Frankenstein starts cranking on a glow-plug that zaps the hapless suffering doggie in his care with a tincture of one-too  many “bacteriophages,” the targeted bacteria wither and go tits-up while sending the dog into shock and (ready for this?) into “necrotizing fasciitis (NF).” (Does NF remind you of the FDA’s black box warning about reported tendonitis and ruptures at the Achilles heal where the tendons melt-away and snap?)  All the ususal suspect and commonplace bacteria causing prostatitis or pelvic floor pain or UTIs have now become “flesh-eating” bacteria, and while the retard under Frankensteins’s direction can now piss without pain, damn it, the little bastard cannot stand up on his own two (or four) feet which have turned to goo!  You see that I have “anthropomorphized” the dog’s experience and minted it as human experience.  The dog arrives sick and departs sicker (so much for the “dog with two dicks,” this poor dog might emerge in shock because his pecker fell-off post treatment.)  The vet conversely arrives with empty pockets and leaves with jingle.  That’s my take on this one decrypted research article about a dog who started out with streptococcus bacterium, possibly a little anal itch, and ended up shocked and half-dead with flesh-eating bacteria gobbling up his pecker (just kidding!).  Imagine a dog trying to communicate his post-treatment condition to a veternarian, and you rightly understand how difficult it is for a floxie to communicate his CNS symptoms to a doctor, half of whose three-year residency expenses (according to a recent article in the New York Times) were underwritten by drug companies, who was never trained or equipped to deal with the unintended consequences of PhDs who speak in gibberish and play Frankenstein for employers who hide more half-baked research in numberless cybervaults than they unleash for profit on their unwary and gushing consumers.

—————————————————————————
See reference notes (below) drawn from Wikipedia.
  
***QUOTE***
Necrotizing fasciitis (NF), commonly known as flesh-eating disease or flesh-eating bacteria, is a rareinfection of the deeper layers of skin and subcutaneous tissues, easily spreading across the fascial plane within the subcutaneous tissue. Type I describes a polymicrobial infection, whereas Type II describes a monomicrobial infection. Many types of bacteria can cause necrotizing fasciitis (e.g., Group A streptococcus (Streptococcus pyogenes), Staphylococcus aureus, Vibrio vulnificus, Clostridium perfringens, Bacteroides fragilis). Such infections are more likely to occur in people with compromised immune systems.[1]

Historically, Group A streptococcus made up most cases of Type II infections. However, since at least 2001, another serious form of monomicrobial necrotizing fasciitis has been observed with increasing frequency.[2] In these cases, the bacterium causing it is methicillin-resistant Staphylococcus aureus (MRSA), a strain of S. aureus that is resistant to methicillin, the antibiotic used in the laboratory that determines the bacterium’s sensitivity to flucloxacillin or nafcillin that would be used for treatment clinically.

A mitogen is a chemical substance that encourages a cell to commence cell division, triggering mitosis. A mitogen is usually some form of a protein.

bacteriophage (băktÄ“r’ēəfāj’), virus that infects bacteria and sometimes destroys them by lysis, or dissolution of the cell. Bacteriophages, or phages, have a head composed of protein, an inner core of nucleic acid-either deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)-and a hollow protein tail. A particular phage can usually infect only one or a few related species of bacteria; for example, coliphages are DNA-containing viruses that infect only the bacterium Escherichia coli.

A virus infects a bacterial cell by first attaching to the bacterial cell wall by its tail. In coliphages the tail is a complex protein structure consisting of a hollow contractile sheath, with a plate at the base that contains long protein fibers. The tail fibers fix the base plate to the specific receptor site on the bacterial cell wall, and the tail sheath contracts like a syringe, forcing the DNA that is inside the virus through the cell wall and cell membrane. The entire virus protein coat remains outside the bacterium.

The injected nucleic acid is the viral genetic material; it makes use of the bacterium’s chemical energy and biosynthetic machinery to produce viral enzymes, as well as more phage nucleic acid. The viral proteins and nucleic acid molecules within the bacterial host assemble spontaneously into up to a hundred new phage particles. Eventually the bacterium lyses, releasing the particles. Lysis can be readily observed in bacteria growing on a solid medium, where groups of lysed cells appear as clear areas, or plaques.

Some DNA phages, called temperate phages, only lyse a small fraction of bacterial cells; in the remaining majority of the bacteria, the phage DNA becomes integrated into the bacterial chromosome and replicates along with it. In this state, known as lysogeny, the information contained in the viral nucleic acid is not expressed. A lysogenic bacterial culture can be treated with radiation or mutagens, inducing the cells to begin producing viruses and lyse. Lysogenic phages resemble bacterial genetic particles known as episomes. Incorporated phage genes are sometimes the source of the virulence of disease-causing bacteria.

The bacteriophage was discovered independently by the microbiologists F. W. Twort (1915) and Félix d’Hérelle (1917). The phages have been much used in the study of bacterial genetics and cellular control mechanisms largely because the bacterial hosts are so easily grown and infected with phage in the laboratory. Phages were also used in an attempt to destroy bacteria that cause epidemic diseases, but this approach was largely abandoned in the 1940s when antibacterial drugs became available. The possibility of “phage therapy” has recently attracted new interest among medical researchers, however, owing to the increasing threat posed by drug-resistant bacteria. In 2006 the Food and Drug Administration approved the use of  blah blah blah
END QUOTE

Cipro victim’s debilitating effects.

Saturday, February 20th, 2010

I started taking 500 mg of Cipro 2 x’s/day for a 10 day dosage after my Doctor thought I had a sinus infection. The 1st night didn’t seem odd. Just felt really tired. The next day I had a debilitating headache. Continued to take. On the 3rd day, I wanted to die. The headaches were so unbearable & I kept jerking awake for no reason. I begged my husband to take me to the ER after I felt like I couldn’t breath & my heart wasn’t beating right, but he said to calm down it was only lack of sleep. Couldn’t fall asleep at all. My Doctor ordered Ct scan, that came back negative. I then was admitted into the ER when my left side went tingly then numb. They did an MRI, which came back negative. I could no longer take care of my minor children and had to have my own mother come & pick me up from 2 hours away because I could no longer take care of myself. By this time I figured that the Cipro was the culprit & had been off for about 1 week. That is when the real hell started. My body was exhausted, but my brain would not go to the stage 2 of sleeping it was supposed to. I couldn’t even yawn.(I know sounds weird) My mother thought I was just having anxiety attacks. I went to another Doctor who said I had acute tendonitis in my entire body due to hypersensitivity of Cipro. 1 day later I woke up to uncontrollable eye movements & a paralyzed body.

 My mother brought me to the ER where they did Spinal tap that came back, you guessed it, negative. One of the doctors even sat there and said it was all in my head. I begged them to take me in then so I could be sedated and not have to deal with the pain. Then they said your not crazy. Go figure, 1st they say I am crazy, then they say I am not. It has been 2 weeks later and the headaches are still there & just as severe along with I cannot move except to use restroom due to being cautious of rupturing anything. I have lost my job, my husband has threatened me with divorce because he believes I am making this up. I went back to the original doctor today that prescribed the Cipro in the first place & he refused to treat me anymore. I was so mad & frustrated. The one doctor that did agree it was from the Cipro is 2 hours away & I cannot drive. I feel so helpless & don’t know if this will ever get better. Before all this, like so many others I was very active. I walked for 2 hours everyday, played with my kids, kept house, worked fulltime, etc.

Levaquin samples given out. Another victim.

Tuesday, February 16th, 2010

I was 52 years old , had started taking my health serious and had been eating right and doing light exercise , I had my waist down to 32 inches was 5′11′ and weighed 175 I had a prostate problem that would not go away , took Cipro Bactrin  one of the Floxins then the doctor who had never taken a sample to see what the bacteria was , gave me Levaquin , he gave me samples and no one in his office kept track and I messed up the dosage and took 4 a day instead of 1  within 2 weeks I was a cripple , I had torn tendons herniated discs torn muscles , torn rotator cuffs and everyone I talked to said the Levaquin would not have done that, of course I knew they were wrong , I wasn’t taking anything else, the antibiotics never did help the prostate problem , it turned out I was sitting on a chair that was too hard for long periods of time and I was bruised inside , if the doctor had just tested me onvce in the 3 years he treated me this would not have happened , this guy no longer practices medicine and left town.

Levaquin sufferer.

Monday, February 8th, 2010

Another victim’s message:

I was on levaquinn for a pneumonia infection and the first night of taking it i was almost in the er i couldnt breath and had sever anxiety attack which ive never in my life had before.. i never had tendon problems but i have everything else..i cant ever fall asleep, really bad insomia..i couldnt breath and my arms are really shaky all the time it doesnt look shaky but i shake inside really bad its hard to explain the feelings i get.. my eyes twiched for about a week and stopped but its really scary i just want to be normal im only 23 i feel like im never gonna be myself again my neck is itchy and always red  and my left eye lid is always red i dont know what to do because nobody believes me not my parents or doctors

Risperdal Kickback case.

Sunday, February 7th, 2010

Risperdal Kickback Case.

By Jim Edwards | Jan 18, 2010

Executives at Johnson & Johnson (JNJ) saw ethical red flags in their relationship with Omnicare (OCR) as early as 1999, according to copies of their emails. One even contemplated the possibility of going to jail, the emails show.

On at least four occasions between 1999 and 2004, J&J execs raised questions over whether their arrangement with Omnicare — in which J&J paid Omnicare millions in rebates if J&J’s drugs increased their market share among Omnicare’s nursing home patients — was ethical or legal, according to the emails and documents.

On Jan. 15, 2010, the Department of Justice sued J&J, alleging that rebates for drugs such as the antipsychotic Risperdal were illegal kickbacks that artificially increased Omnicare’s annual purchases of J&J drugs from approximately $100 million to more than $280 million. Much of the purchases were reimbursed by Medicaid, the suit alleges, and J&J’s drugs made huge gains in market share as Omnicare, the dominant pharmacy supplier for nursing homes, pushed J&J brands at the expense of their competitors. J&J said in a statement:

“We are reviewing the complaint filed today and will address the government’s lawsuit in court.  We believe airing the facts will confirm that our conduct, including rebating programs like those the government now challenges, was lawful and appropriate.  We look forward to the opportunity to present our evidence in court.”

More than a decade earlier, on Sept. 13, 1999, J&J business group account director Bruce Cummins wrote a long email to his colleagues describing a tense series of negotiations with Omnicare (see page 252 of the complaint). The two companies had fallen out in part because Omnicare’s copy of the contract was missing pages when it was signed. The upshot was that Omnicare believed it was owed about $700,000 in rebates that it had not received. It was Cummins’ job to convince Omnicare that it was mistaken; only half of that sum was owed.

Part of his argument was that if additional “overlays” were paid to Omnicare they may violate the contract, Cummins told his colleagues. “Based on the continuing scrutiny regarding abuse in our industry, we must follow contractual issues to the letter. No overlay’s will be paid for 97-98 or 98-99,” he wrote. However, Cummins indicated that Omnicare could be paid extra in other ways, “outside the JJHCS contract to see if anything can be done…”

Cummins then went on to describe an angry exchange he had with Omnicare’s director of purchasing, Dan Maloney, in which the Omnicare man demanded money. Cummins told him, “I wasn’t going to go to jail for Dan, Omnicare, or for that matter J&J”:


(Click to enlarge images.)

Cummins’ position was backed by Martine Grant, a colleague within J&J’s Health Care Systems division. She had written to colleagues on May 19, 1999, that “going above the contract put us at risk for fraud and abuse”:

On July 11, 2000, a solution was proposed. J&J would pay Omnicare “consultant services revenue” to replace the lost “overlay” money:

A $750,000 contract was eventually signed in October 2000, according to the DOJ’s complaint (see page 276).

That contract, however, triggered a new problem for J&J. Now that it was paying Omnicare the extra money, J&J had to make sure the performance on the contract was documented to make sure it met with their own compliance standards — and didn’t look like a kickback to make sure Omnicare promoted Risperdal. On July 22, 2002, Petro Thomas from J&J’s HCS group emailed his colleagues to warn them that they were “under heavy scrutiny from the corporate legal team” and that they should make up the rebates “in another way”:

By September 2003, it became clear that to properly document the consulting contract, J&J would need to show what it received from Omnicare in return for its money. Charles Chartier, an account director at J&J, emailed his colleagues in a search for “any lists” Omnicare might have given J&J, even if only “randomly,” or if the information was written on “scratch pads”:

The effort appeared to work, the emails show. In 2002, J&J’s Levaquin antibiotic saw a 19 percent share gain in five months. The reaction of one executive, informed of the news in an email was that it was “scary” that the company had such power:  

 

 

Medical schools response to ghostwriting scandals.

Wednesday, February 3rd, 2010

Med schools not responding to ghostwriting scandals 

The open access journal PLoS Medicine has been at the forefront of a closely related issue: full disclosure. In 2009, it was on the winning side of a suit that helped reveal the extent of ghostwriting in the biomedical literature. The practice, in which pharmaceutical companies pay for the production of a medical research article without the activity being disclosed, can distort the scientific record. Now, the journal has published a new study that indicates few of the top medical schools have any policy in place to govern ghostwriting among their faculty.

Most medical journals recognize that industry-sponsored studies can suffer from conflicts of interest, and may selectively promote positive results or underplay the significance of negative ones. As a result, they generally demand that all authors of a paper disclose potential conflicts. This specific form of ghostwriting undercuts that process: since the writers aren’t credited, their conflicts never get listed. The new article cites specific instances where misleading results were ghostwritten in a way that minimized the issues with Vioxx and Paxil.

So, how are medical institutions responding to this problem? For the most part, they’re not. The authors searched for policies regarding authorship and ghostwriting at the top 50 medical research centers and, in over half the cases, failed to find any, even after consulting research librarians at those institutions. Only 10 specifically prohibit ghostwriting, while another three have stringent authorship policies that effectively block its use.

The authors make an impassioned argument that this must change, as they view ghostwriting as a public health threat, and one that violates academic norms. They call on deans of academic medical centers to explicitly ban the practice by the end of this academic year, and call on the National Institutes of Health to refuse to fund any research at institutions that refuse. It would be a radical measure, but the institutions are apparently not responding to repeated discoveries of unethical behavior, suggesting something radical might be needed.

PLoS Medicine, 2010. DOI: 10.1371/journal.pmed.1000230