Showing posts with label Bayer. Show all posts
Showing posts with label Bayer. Show all posts

Tuesday, January 28, 2014

Bayer CEO: Cancer Drug Is Only For Westerners Who Can Afford It

By Adam Peck on January 26, 2014 - ThinkProgress
BAYER CEO Marijn Dekkers
BAYER CEO Marijn Dekkers
Fuck him! Asshole!

In 2005, the FDA granted approval for a promising new cancer-fighting drug called Nexavar. Bayer took it to market shortly thereafter, and it is currently an approved treatment for late-stage kidney and liver cancer.

That is, so long as you live in the developed world. In a recently published interview in Bloomberg Businessweek, Bayer CEO Marijn Dekkers said that his company’s drug isn’t for poor people.

“We did not develop this medicine for Indians…we developed it for western patients who can afford it,” he said back in December. The quote is quickly making its way across Indian news outlets.

The comment was in response to a decision by an Indian patent court that granted a compulsory license to a local company to reproduce Bayer’s drug. Under Indian patent laws, if a product is not available locally at a reasonable cost, other companies may apply for licenses to reproduce those products at a more affordable price. Nexavar costs an estimated $69,000 for a full year of treatment in India, 41 times the country’s annual per capita income.

In 2012, Indian pharmaceutical company Natco Pharma Ltd. applied for just such a license, and it was granted. The company began reproducing the drug at a 97 percent discount, offering it for just $177. Bayer has been appealing the ruling ever since, and in December Dekkers told Businessweek that he viewed the compulsory license as “essentially theft” before dismissing poor Indian cancer patients.

Pharmaceutical companies have long been accused of ignoring the plight of those who cannot afford their astronomical prices. In the United States, where insurance companies often pick up most of the tab, consumers are often shielded from the true cost of drugs they are prescribed (Nexavar, for example, costs as much as $96,000 in the United States, but Bayer ensures that eligible US patients only see a $100 copay).

Dekkers’ quote brings into sharp relief the industry’s general ambivalence towards the developing world. A 2012 report from Doctors Without Borders found that most pharmaceutical companies devote only a small fraction of their operating budgets to fighting diseases that disproportionally affect — and kill — millions of the world’s poorest people.

Monday, January 2, 2012

Health Tyranny: Codex Alimentarius, part 1

Excerpt from Codex Alimentarius -- The End of Health Freedom

Brandon Turbeville -- Activist Post

Contrary to popular belief Codex Alimentarius is neither a law nor a policy.  It is in fact a functioning body, a Commission, created by the Food and Agricultural Organization and the World Health Organization under the direction of the United Nations. The confusion in this regard is largely due to statements made by many critics referring to the “implementation” of Codex Alimentarius as if it were legislation waiting to come into effect. A more accurate phrase would be the “implementation of Codex Alimentarius guidelines,” as it would more adequately describe the situation.

Codex is merely another tool in the chest of an elite group of individuals whose goal is to wield complete control over the world. Power over the food supply is essential in order to achieve this. As will be discussed later, Codex Alimentarius will be “implemented” whenever guidelines are established and national governments begin to arrange their domestic laws in accordance with the standards set by the organization.

The existence of Codex Alimentarius as a policy-making body has roots going back over a hundred years. The name itself, Codex Alimentarius, is Latin for “food code”[1]  and directly descended from the Codex Alimentarius Austriacus, a set of standards and descriptions of a variety of foods in the Austria-Hungarian Empire between 1897 and 1911.[2] This set of standards was the brainchild of both the food industry and academia and was used by the courts in order to determine food identity in a legal fashion.

Even as far back as 1897, nations were being pushed toward harmonization of national laws into an international set of standards that would reduce the “barriers to trade” created by differences in national laws.[3] As the Codex Alimentarius Austriacus gained steam in its localized area, the idea of having a single set of standards for all of Europe began to pick up steam as well. From 1954-1958, Austria successfully pursued the creation of the Codex Alimentarius Europaeus (the European Codex Alimentarius). Almost immediately the UN directed FAO (Food and Agricultural Organization) sprang into action when the FAO Regional Conference for Europe expressed the desire for a global international set of standards for food. The FAO Regional Conference then sent a proposal up the chain of command to the FAO itself with the suggestion to create a joint FAO/WHO programme dealing with food standards.

The very next year, the Codex Alimentarius Europeaus adopted a resolution that its work on food standards be taken over by the FAO. In 1961, it was decided by the WHO, Codex Alimentarius Europaeus, Organization for Economic Co-operation and Development (OECD), and the FAO Conference to create an international food standards programme known as the Codex Alimentarius.[4]  In 1963, as a result of the resolutions passed by these organizations two years earlier, Codex Alimentarius was officially created.[5]

Although created under the auspices of the FAO and the WHO, there is some controversy regarding individuals who may or may not have participated in the establishment of Codex. Many anti-Codex organizations have asserted that Nazi war criminals, Fritz Ter Meer[6] and Hermann Schmitz[7] in particular, were principal architects of the organization. Because many of these claims are made with only indirect evidence, or no evidence at all, one might be tempted to disregard them at first glance. However, as the allegations gain more and more adherents, Codex has attempted to refute them. In its Frequently Asked Questions section, Codex answers the question, “Is it true that Codex was created by a former war criminal to control the world food supply?”[8]  It then goes on to answer the charges by stating:
No. It is a false claim. You just need to type the words "Codex Alimentarius" in any search engine and you will find lots of these rumors about Codex. Usually the people spreading them will give no proof but will ask you to send donations or to sign petitions against Codex
Truthful information about Codex is found on the Internet - there is nothing to hide from our side - we are a public institution working in public for the public - we are happy if people want to know more about our work and ask questions. There is an official Codex Contact Point in each member country who will be pleased to answer your questions on Codex.[9]
But, as one can see from the statement above, Codex’s response does very little to answer this question beyond simply disagreeing with it. While it is true that many individuals who make this claim provide little evidence for it, the presentation of the information does not necessarily negate its truthfulness. In fact, Codex offers its own website as a source for accurate information about the organization; yet, beyond the FAQ section, there is nothing to be found that is relevant to the “war criminal” allegations. Furthermore, the codexalimentarius.net website is virtually indecipherable, almost to the point of being completely useless. In the end, this response raises more questions than it answers. This is because Codex, if it wanted, could put these rumors to rest by simply posting a list of the individuals and organizations that funded or played an integral role in its creation. However, it does nothing of the sort. Beyond mentioning the FAO and the WHO, we are completely unaware of who or how many other individuals and organizations participated in the creation of Codex Alimentarius.

The “war criminal” claims center around the chemical conglomerate known as I.G. Farben. I.G. Farben was made up of several German chemical firms including, BASF, Bayer, Hoechst and AGFA,[10] that merged together. It was essentially the manufacturing wing of the Third Reich and was the engine behind the Nazi war machine. The company provided the vast majority of explosives and synthetic gasoline used for the military conquest and murder of millions. It also manufactured the now infamous Zyklon-B gas used in the gas chambers.  Not only that, but it was influential in the conducting of experiments on concentration camp victims. Indeed, camp victims were often purchased outright at the behest of the company for the express purposes of testing by several different branches of the company, particularly Bayer and Hoechst.

Without I.G. Farben, the German wars simply could not have been sustained. During the Nuremberg war trials, the tribunal convicted 24 board members and executives of the company and dissolved it into several different daughter companies. Namely, BASF, Hoechst (later to be known as Aventis), and Bayer. By 1951, virtually all 24 of these executives were released, including Fritz Ter Meer and Hermann Schmitz. Ter Meer had been a member of the I.G. Farben executive committee from 1926-1945 and also a member of the working committee and the technical committee as well as a director of the infamous Section II. He was also the ambassador to Italy given full power by the Reich Minister for armaments and war production and was the industrialist most responsible for Auschwitz. Schmitz was also a member of the I.G. Farben executive committee from 1926-1935, and was chairman of the board and “head of finances” from 1935-1945. He was also head of military economics and a member of the Nazi party. Both men were found guilty by the Nuremberg war tribunal in 1948, yet Schmitz was released in 1950 and Ter Meer in 1952.[11]

After all this, Schmitz was appointed board member of the German bank of Berlin West in 1952 and in 1956, the honorary chairman of the board of Rheinish steel plants. Ter Meer, however, was even more successful. Upon his release, he was appointed board member of Bayer in 1955 and, in 1956 was appointed chairman. In the years following, he would take on many additional roles such as chairman of the board of Theodore Goldschmidt AG, deputy chairman of the board of Commerzbank and Bank-Association AG, as well as a board member of the Waggonfabrik Uerdingen, Duesseldorger Waggonfabrik AG, the bank association of West Germany, and United Industrial Enterprises AG.[12] These are documented connections for both of these men. Indeed, Ter Meer’s’ connections to the pharmaceutical firm Bayer earned him a foundation named in his honor, the Fritz Ter-Meer Foundation.[13] Through all of this however, this writer could not confirm that either Ter Meer or Schmitz had direct connections to the creation of Codex Alimentarius.

However, Codex does nothing to dispel the allegations besides simply disagreeing with them and the connections are not at all implausible. Codex is very secretive about its beginnings, as evidenced on its website where it only states that it was created at the behest of the FAO and the WHO. It is highly unlikely that such an organization would be created without the assistance, input, and even funding of privately owned international corporations. Thanks to both the anti-Codex community and Codex Alimentarius itself, there is no evidence (again at least to this author) that documents which individuals or corporations were involved in its establishment. However, there are other ties that lend more credence to the belief that war criminals played a role in the creation of Codex.

[1]  Tips, Scott C. “Codex Alimentarius: Global Food Imperialism.” FHR. 2007. P. ii.

[2]  “Opening Statement by Dr. B.P. Dutia Assistant Director-General Economic and Social Policy Department, FAO to the Nineteenth Session of the Codex Alimentarius Commission.” Food and Agricultural Organization. July 1, 1991.  http://www.fao.org/docrep/meeting/005/t0490e/T0490E04.htm

See also,

Taylor, Paul Anthony. “Codex Guidelines for Vitamins and Minerals – Optional or Mandatory?” Dr.Rath Health Foundation. http://www4.dr-rath-foundation.org/features/codex_wto.html

[3]  “Codex Alimentarius: how it all began.” Food and Agricultural Organization.  http://www.fao.org/docrep/v7700t/v7700t09.htm   Accessed April 23, 2010.

[4]  “Understanding the Codex Alimentarius.” World Health Organization. Food and Agricultural Organization. 2006. P. 7 http://www.scribd.com/doc/25710873/WHO-Understanding-the-Codex-Alimentarius   Accessed April 23, 2010.

[5]  Tips, Scott C. “Codex Alimentarius: Global Food Imperialism.” FHR. 2007. P.ii

[6]  “The History of the ‘Business With Disease.’” Dr. Rath Health Foundation. http://www4.dr-rath-foundation.org/PHARMACEUTICAL_BUSINESS/history_of_the_pharmaceutical_industry.htm Accessed April 26 <http://www4.dr-rath-foundation.org/PHARMACEUTICAL_BUSINESS/history_of_the_pharmaceutical_industry.htm%20Accessed%20April%2026> , 2010.

[7]  Minton, Barbara. “Codex Threatens Health of Billions.” Naturalnews. July 30, 2009. http://www.naturalnews.com/026731_CODEX_food_health.html

[8]  “FAQs – Rumours” CodexAlimentarius.net  http://www.codexalimentarius.net/web/faq_rum.jsp#R1  Accessed April 26, 2010.

[9]  Ibid.

[10]  Behreandt, Dennis. “The crimes of I.G. Farben: during WWII, I.G. Farben, a synthetic-fuels manufacturer for the German war machine, was a major supporter of the Nazi regime and a willing co-conspirator in the Holocaust.” The New American. November 27, 2006. http://findarticles.com/p/articles/mi_m0JZS/is_24_22/ai_n24996865/  Accessed April 26, 2010.

See also,

“The Documentation About ‘Codex Alimentarius.’” Dr. Rath Health Foundation. http://www4.dr-rath-foundation.org/PHARMACEUTICAL_BUSINESS/health_movement_against_codex/health_movement24.htm  Accessed April 26, 2010.

[11]  “The History of the ‘Business With Disease.’” Dr. Rath Health Foundation. http://www4.dr-rath-foundation.org/PHARMACEUTICAL_BUSINESS/history_of_the_pharmaceutical_industry.htm Accessed April 26 <http://www4.dr-rath-foundation.org/PHARMACEUTICAL_BUSINESS/history_of_the_pharmaceutical_industry.htm%20Accessed%20April%2026> , 2010.

[12]  Ibid.

[13]  Weimbs Lab: Molecular, Cellular and Developmental Biology University of California, Santa Barbra. http://www.lifesci.ucsb.edu/mcdb/labs/weimbs/people/weimbs/index.html   Accessed April 27, 2010. Dr. Thomas Weimbs received a scholarship from the Fritz ter Meer Foundation in 1988.

Monday, May 30, 2011

Raw Opium

(Bayer invented heroin. That is funny for some reason.--jef)


Wednesday, December 29, 2010

Drug Industry Fraud

The Whistle Has Been Blown, But Where's the Enforcement?
By RALPH NADER

The corporate defrauding of taxpayers (eg. Medicaid and Medicare) and prescription drugs with skyrocketing prices was the subject of a report by Public Citizen's Dr. Sidney Wolfe and his associates (see citizen.org).

Dr. Wolfe's team compiled a total of 165 federal and state settlements since 1991 totaling $19.8 billion in penalties. A key finding is that the drug industry's penalties under the Federal False Claims Act exceed even those assessed against the overcharging defense industry for fraud.

Before we become overly impressed with the cumulative amount of the penalties, specialists in corporate crime law enforcement believe that adding more federal cops on the corporate crime beat, backed by a determined law and order Justice Department with White House backing, would have greatly increased the number of cases and imposition of penalties on these drug industry giants.

Nonetheless, Dr. Wolfe's study shows that the pace of penalties has picked up over the past five years. This is due to "a combination of increased violations by companies and increased law enforcement on the part of federal and state governments," says the report.

Many of these cases were initiated by company whistleblowers, who under the False Claims Act can receive a share of the settlements. Since the corporate bosses of these drug firms are almost never prosecuted, what these executives fear the most are company employees who go public with the evidence of corporate misdeeds.

These violations do more than financial damage to consumers and government health insurance programs. One of the worst violations involves companies promoting unproven, often dangerous uses for their medicines. Last year, Pfizer paid $1.2 billion for illegal off-label promotion -the largest criminal fine in U.S.history. Other major corporate violators were GlaxoSmithKline, Eli Lilly, Schering-Plough, Bristol-Myers Squibb, AstraZeneca, TAP Pharmaceutical, Merck, Serono, Purdue, Allergan, Novartis, Cephalon, Johnson & Johnson, Forest Laboratories, Sanofi-aventis, Bayer, Mylan, Teva and King Pharmaceuticals.

The violations by these and other drug companies point to the wide range of impacts, including taking many lives of patients, which stems from these recurrent activities. These criminal or civil illegalities cover (1) overcharging government health programs, (2) unlawful promotion, (3) monopoly practices, (4) kickbacks, (5) concealing study findings, (6) poor manufacturing practices, (7) environmental violations, (8) financial violations and (9) illegal distribution.

Outside the purview of the Public Citizen study are the ravages of counterfeit drugs and poorly inspected ingredients in drugs, now mostly coming from China and India, due to the outsourcing by U.S. and European drug companies in their thirst for even greater profits.

Drug company sales are huge, growing from $40 billion in 1990 to $234 billion in 2008, and far exceeding inflation with their annual price gouging. To make matters worse, in 2003, the Congressional Republicans, with decisive support from some Democrats, passed the drug benefit bill which explicitly prohibited Uncle Sam, the payer, from bargaining for volume discounts with drug companies.

With over 400 full-time drug company lobbyists putting pressure on Congress, and tens of millions of dollars flowing into the legislators' campaign coffers, budgets for federal investigators, prosecutors and inspectors are kept to a minimum. Unfortunately, crime in the suites pays over and over again, despite occasional penalties.

A bright spot is the increasing enforcement action at the state level.

By last year, 32 states had enacted false claims acts, including fourteen states that qualified as strong laws by federal standards.

Still, the Wolfe report concludes that the "current system of enforcement is not working." He gives the examples of the $7.44 billion in financial penalties assessed over the past twenty years on GlaxoSmithKline and Pfizer, as compared to their combined total of $16.5 billion in global net profits in one year alone.

What would deter these illegal practices and risks to public safety? Dr. Wolfe says "the lack of criminal prosecution that would result in jailing of company executives." is key. Moreover, the report notes that "a felony conviction could result in their companies becoming ineligible for reimbursement from federal and state health programs, a critical source of pharmaceutical company revenues."

A flicker of hope that a little change is on the way came from the Food and Drug Administration's Deputy Chief Counsel for Litigation, Eric Blumberg. He indicated that the government is considering going after drug company executives for violations such as off-label promotions. He stated: ".unless the government shows more resolve to criminally charge individuals-at all levels in the corporate hierarchy--.we can not expect to make progress in deterring off-label promotion."

The problem is that the final operating decision is in the hands of the Justice Department-historically short-staffed and short-willed to entreaties for prosecution by the FDA and other regulatory agencies.

Furthermore, for over 30 years, the Justice Department has stone-walled requests that it start a corporate crime database as it has done with street crimes. Congress likes it this way, as it continues to cash corporate campaign checks.

Just last week, however, outgoing Judiciary Committee Chairman, Democrat John Conyers introduced a bill (H.R. 6545) to create such a corporate crime data base in the Justice Department. Well, as the saying goes, everything starts with a gesture!

Friday, December 17, 2010

The Year in Pills

2010's Hall of Shame
By MARTHA ROSENBERG

2010 will go down as the year the diet pill Meridia and pain pill Darvon were withdrawn from the market and the heart-attack associated diabetes drug Avandia was severely restricted.

But it was also the year the Justice Department filed the first criminal, not civil, charges against a drug company executive. Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline, hid some 1,000 instances of GSK-paid doctors illegally promoting Wellbutrin to other doctors, say authorities.

It was also the year prominent psychiatrists Charles Nemeroff and Alan Schatzberg were accused of writing an entire book for GSK called Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care.

Here are the drugs which make 2010's Hall of Shame.

Yaz and Yasmin

Soon after Bayer launched the pill Yaz in 2006, billing it as going "beyond birth control," 18-year-olds were coming down with blood clots, gall bladder disease, heart attacks and even strokes. FDA ordered Bayer to run correction ads that detail the drugs' risks though Yaz sales are still brisk. In fact, financial analysts attribute a third quarter slump to a Yaz generic coming online, not dangerous side effects.

Lyrica, Topamax and Lamictal

In August FDA ordered a warning on the seizure drug Lamictal for aseptic meningitis (brain inflammation) but it is still the darling of military and civilian doctors for unapproved pain and migraine uses. All three drugs increase the risk of suicidal thoughts and behaviors according to their mandated labels, in addition to the memory and hair loss patients report.

Humira, Prolia and TNF Blockers

The drug industry's highly promoted biologic drugs are made from genetically engineered hamster cells and suppress the immune system, inviting tuberculosis and several cancers. Yet Humira is advertised to healthy people for "clearer skin" and Prolia is advertised to prevent osteoporosis in healthy women.

Chantix

After 397 FDA cases of possible psychosis, 227 domestic reports of suicidal behaviors and 28 actual suicides, the government banned pilots, air-traffic controllers and interstate truck and bus drivers from taking the antismoking drug Chantix in 2008. Its neuropsychiatric effects were immortalized when New Bohemians musician Carter Albrecht was shot to death in 2007 in Texas by a neighbor after acting aggressively on the Chantix.

Ambien

The sleeping pill Ambien was immortalized as the drug Tiger Woods reportedly cavorted with his consorts on and former US Rep. Patrick Kennedy crashed his Ford Mustang on, while driving to Capitol Hill in the middle of the night to "vote" in 2006. Law enforcement officials say it has increased traffic accidents from people who drive in a black out and don't even recognize arresting officers.

Tamoxifen

Is it a coincidence that Tamoxifen maker AstraZeneca founded Breast Cancer Awareness Month and makes carcinogenic agrochemicals that cause breast cancer? As a breast cancer prevention drug, an American Journal of Medicine study found the average life expectancy increase from Tamoxifen was nine day . Public Citizen says for every case of breast cancer prevented on Tamoxifen there is a life-threatening case of blood clots, stroke or endometrial cancer.

Lipitor and Crestor

Why is Lipitor the best selling drug in the world? Because every adult with high LDL or fear of high LDL is on it. And also 2.8 million children, says Consumer Reports. All statins can cause muscle breakdown called rhabdomyolysis. And Crestor is so linked to the side effect, Public Citizen calls it a Do Not Use and the FDA's David Graham named it one of the five most dangerous drugs before at a Congressional hearing.

Boniva

Boniva and other bisphosphonate bone drugs are a good example of FDA approving once unapprovable drugs by transferring risk onto the public's shoulders. The list of dangers on the label includes waiting 60 minutes before eating or drinking anything except plain water, never taking the drug with mineral water, sparkling water, coffee, tea, milk, juice or other oral medicine, including calcium, antacids, or vitamins and not lying down after you take it.
Prempro

Pfizer's hormone drug Prempro is linked to a 26 percent increase in breast cancer, 41 percent increase in strokes, 29 percent increase in heart attacks, 22 percent increase in cardiovascular disease and double the rate of blood clots. But its cognitive and cardiovascular "benefits" are being tested right now at major universities to debut an HT "Light," hoping the public has a short memory.

Prozac, Paxil, Zoloft, SSRIs

Selective serotonin reuptake inhibitor (SSRIs) antidepressants like Prozac, Paxil, Zoloft and Lexapro probably did more to inflate drug industry profits than Viagra. But many say the drugs have also inflated police blotters. In addition to 4,200 published reports of SSRI-related violence, including the Columbine, Red Lake and NIU shootings, SSRIs can cause serotonin syndrome and gastrointestinal bleeding when taken with certain drugs. Paxil is linked to birth defects.

Effexor, Cymbalta, Pristiq, SNRIs

Selective norepinephrine reuptake inhibitors (SNRIs) are like their SSRIs chemical cousins except their norepinephrine effects can modulate pain, which has ushered in your-depression-is-really-pain, your-pain-is-really-depression and other crossover marketing. SNRI's are also harder to quit than SSRIs. 739,000 web sites address "Effexor" and "withdrawal."
Seroquel, Zyprexa, Geodon, atypical antipsychotics

The antipsychotic Seroquel tops 71 drugs on the FDA's January 2010 adverse event report and is linked to unexplained troop deaths and many research scandals. But it's the fifth biggest-selling drug in the world. Atypical antipsychotics cause weight gain and diabetes, the tardive dyskinesia they are marketed to prevent and death in the demented elderly. Yet FDA approved Zyprexa and Seroquel for children last year and the new atypical antipsychotic, Latuda this year. Maybe the FDA is bipolar.

Ritalin, Concerta, Strattera, Adderall and ADHD Drugs

ADHD drugs rob "kids of their right to be kids, their right to grow, their right to experience their full range of emotions, and their right to experience the world in its full hue of colors," says Anatomy of an Epidemic author Robert Whitaker. But they are a gold mine for the drug industry. During an August conference call with financial analysts, Shire specialty pharmaceuticals president Mike Cola lauded the "very dynamic ADHD market," and the "co-administration market" (in which kids don't need one drug but several.

Gardasil and Cervarix Vaccines

A pharma-government plot to inoculate the public with dangerous vaccines? Maybe not but why are governors like Texas' Rick Perry mandating vaccination of girls for HPV? And why was University of Queensland lecturer Andrew Gunn silenced when he questioned the Gardasil vaccine? The HPV vaccine doesn't work for all viral strains, requires a boo$ter and is linked to 56 US girls' deaths as of September, according to the CDC.

Foradil Aerolizer, Serevent Diskus, Advair and Symbicort

Unlike drugs that look safe in trials and develop "safety signals" postmarketing, the long-acting beta agonists (LABA), salmeterol and formoterol, found in many asthma drugs, never looked safe. Studies link them to an increase in asthma deaths, especially in African-Americans and children. They may have contributed to 5,000 deaths said Dr. David Graham at FDA hearings about the controversial asthma drugs.

Singulair and Accolate, leukotriene receptor antagonists

Leukotriene receptor antagonists also never looked safe. Original FDA reviewers said asthma control "deteriorates" on Singulair and it may not be safe in children. Last month, Fox TV reported Singulair, Merck's top selling drug, is suspected of producing aggression, hostility, irritability, anxiety, hallucinations and night-terrors in kids, symptoms that are being diagnosed as ADHD. It is huckstered to parents by the trusted educational service Scholastic, Inc. and the American Academy of Pediatrics.

Saturday, November 20, 2010

Dangerous Drugs Big Pharma Shoves Down Our Throats

In the pharmaceutical industry’s rush to get drugs to market, safety usually comes last. And the public suffers. 
By Martha Rosenberg, AlterNet
November 19, 2010
In the pharmaceutical industry’s rush to get drugs to market, safety usually comes last. Long studies to truly assess a drug's risks just delay profits after all -- and if problems do emerge after medication hits the market, settlements are usually less than profits. Remember, Vioxx still made money.

The following drugs are so plagued with safety problems, it is a wonder they’re on the market at all. It's a testament to Big Pharma's greed and our poor regulatory processes that they are.


-- Lipitor and Crestor
Why is Lipitor the bestselling drug in the world? Because every adult with high LDL or fear of high LDL is on it. (And also 2.8 million children, says Consumer Reports.) No one is going to say statins don't prevent heart attack in high-risk patients (though diet and exercise have worked in high-risk groups too). But doctors will say statins are so over-prescribed that more patients get their side effects -- weakness, dizziness, pain and arthritis -- than heart attack prevention. Worse, they think it's old age!
"My older patients literally do without food so that they can buy these medicines that make them sicker, feel bad, and do nothing to improve life," says an ophthalmologist web poster from Tennessee. "There is no scientific basis for treating older folks with $300+/month meds that have serious side-effects and largely unknown multiple drug interactions." What kinds of side effects? All statins can cause muscle breakdown (called rhabdomyolysis) but combining them with antibiotics, protease inhibitors drugs and anti-fungals increases your risks. In fact, Crestor is so highly linked to rhabdomyolysis it is double dissed: Public Citizen calls it a Do Not Use and the FDA's David Graham named it one of the five most dangerous drugs before Congress.


-- Yaz and Yasmin
It sounded too good to be true and it was. Birth control pills that also cleared up acne, treated severe PMS (Premenstrual Dysphoric Disorder or PMDD) and avoided the water retention of traditional birth control pills.
But soon after Bayer launched Yaz in 2006 as going "beyond birth control," 18-year-olds were coming down with blood clots, gall bladder disease, heart attacks and even strokes. Fifteen-year-old Katie Ketner had her gallbladder removed. Susan Gallenos had a stroke and part of her skull removed. College student Michelle Pfleger, 18, collapsed and died of a pulmonary thromboemboli from taking Yaz, says her mother Joan Cummins.
While TV ads for Yaz in 2008 were so misleading that FDA ordered Bayer to run correction ads, Yaz sales are still brisk. In fact, financial analysts attribute the third quarter slump in the Yaz "franchise" of 28.1 percent to the appearance of a Yaz generic, not to the thousands of women who have been harmed.

Why is Yaz sometimes deadly? It includes a drug that was never before marketed in the U.S. -- drospirenone -- and apparently causes elevated potassium, heart problems, and a change in acid balance of the blood. Who knew? But not only is Bayer still marketing it, women do not receive "test subject" compensation for using it either.

-- Lyrica, Topomax and Lamictal

Why would Americans take an epilepsy seizure drug for pain? The same reason they'll take an antipsychotic for the blues and an antidepressant for knee pain: good consumer marketing. In August FDA ordered a warning for aseptic meningitis, or brain inflammation, on Lamictal -- but it is still the darling of military and civilian doctors for unapproved pain and migraine. Lamictal also has the distinction of looting $51 million from Medicaid last year despite a generic existing.
All seizure drugs increase the risk of suicidal thoughts and behaviors according to their mandated labels. An April article in JAMA found seizure drugs linked to 26 suicides, 801 attempted suicides, and 41 violent deaths in just five years.
All three drugs can make you lose your memory and your hair, say posters on the drug rating site askapatient.com. Topamax is referred to as "Stupamax" in the military -- though evidently not enough to ask, "Why am I taking this drug again?"

-- Humira, Prolia and TNF Blockers
If you think pharma is producing a lot of expensive, dangerous injectables lately, you're right. Yesterday's blockbuster pills have been supplanted with vaccines and biologics that are more lucrative and safer...from generic competition, that is. The problem is, not only are biologics like Humira and Prolia creepy and dangerous -- they're made from genetically engineered hamster cells and suppress the actual immune system -- the diseases they treat are "sold" to healthy people.
Recently, thousands of college students in Chicago found inserts in their campus newspapers hawking Humira for Crohn's disease, rheumatoid arthritis and psoriatic arthritis. ("Hate psoriasis? Love clearer skin," says an ad on the Humira Web site featuring a pretty woman.) And earlier this year Prolia was approved by the FDA for postmenopausal osteoporosis with a high risk of fracture. Do healthy people really want to suppress their body's tumor necrosis factor (TNF) and invite tuberculosis, serious, possibly lethal infections, melanoma, lymphoma and "unusual cancers in children and teenagers" as the Humira label warns? Nor is it clear these drugs work. The Humira label warns against developing "new or worsening" psoriasis -- a condition it is supposed to treat.


-- Chantix
How unsafe is the antismoking drug Chantix? After 397 FDA cases of possible psychosis, 227 domestic reports of suicidal acts, thoughts or behaviors and 28 suicides, the government banned pilots and air traffic controllers and interstate truck and bus drivers from taking Chantix in 2008. Four months later, some military pharmacies banned the drug, which reduces both cravings and smoking pleasure. In addition to Chantix' neuropsychiatric effects (immortalized by New Bohemians musician Carter Albrecht, who was shot to death in 2007 in Texas by a neighbor after acting aggressively), Chantix is linked to angioedema, serious skin reactions, visual impairment, accidental injury, dizziness, muscle spasms, seizures and loss of consciousness. In defending an increasingly indefensible drug, Janet Woodcock, director of the FDA Center for Drug Evaluation said last year, "Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit." True enough -- but if you smoke cigarettes you can still drive an interstate truck.

-- Ambien
Sleeping pills like Ambien, Lunesta, Sonata and Rozerem only decrease get-to-sleep time by 18 minutes according to the National Institutes of Health (NIH).
But Ambien has additional cachet compared to its soporific brethren: it is the drug Tiger Woods reportedly used when cavorting with his consorts; and former U.S. Rep. Patrick Kennedy was taking it when he crashed his Ford Mustang while driving to Capitol Hill in the middle of the night to "vote" in 2006.
In fact Ambien's legendary somnambulism side effects -- people walk, drive, make phone calls and even have sex while sleeping -- has increased traffic accidents say law enforcement officials, with some drivers not even recognizing arresting police. Thanks to bad Ambien press, Sanofi-Aventis has had to run ads telling the public to get in bed and stay there if you are going to take Ambien. (Or you'll break out in handcuffs, as the joke goes.) Ambien has also increased the national weight problem as dieters wake up amid mountains of pizza, Krispy Kreme and Häagen-Dazs cartons consumed by their evil twins.

-- Tamoxifen

Is it a coincidence that Tamoxifen maker AstraZenaca founded Breast Cancer Awareness Month and makes carcinogenic agrochemicals that cause breast cancer? Both the original safety studies of Tamoxifen, which causes cancer, birth defects and is a chemical cousin of organochlorine pesticides, and its original marketing were riddled with scientific error. In fact, FDA objected to AstraZeneca's marketing claim of breast cancer prevention and the casting of endometrial cancer as an "uncommon" event 10 years ago.
Yet today pharma-linked doctors still tell women to take Tamoxifen to prevent breast cancer even though an American Journal of Medicine study found the average life expectancy increase is nine days (and Public Citizen says for every case of breast cancer Tamoxifen prevents there is a life-threatening case of blood clots, stroke or endometrial cancer). A Gynecologic and Obstetric Investigation study shows an example of Tamoxifen's downside: 57.2 percent of women on continuous Tamoxifen developed atrophy of the lining of the uterus, 35.7 coexisting hyperphasia and 8.1 percent uterine polyps. We won't even talk about eye and memory problems -- or the Tamoxifen cousin, Evista, that pharma is also pushing which has a "death from stroke" warning on its label.

-- Boniva
Why is the bisphosphonate bone drug Boniva available in a convenient, once-monthly formulation? Could patients balk at the fact that after you take it you have to avoid lying down for at least 60 minutes to "help decrease the risk of problems in the esophagus and stomach," wait at least 60 minutes before eating or drinking anything except water, never take it with mineral water, sparkling water, coffee, tea, milk, juice or other oral medicine, including calcium, antacids, or vitamins, and of course, "do not chew or suck"? Nor should you take Boniva, say the warnings, "if you have difficult or painful swallowing, chest pain or continuing or severe heartburn, have low blood calcium or severe kidney disease or if severe bone, joint and/or muscle pain."
Bone drugs like Boniva, Fosamax and Actonel are a good example of FDA approving once-unapprovable drugs by transferring risk onto the public's shoulders with "we warned you" labels. The warnings are supposed to make people make their own safety decisions. Except that people just think FDA wouldn't have approved it if it weren't safe.


-- Prempro and Premarin
You'd think Pfizer's hormone drugs Prempro and the related Premarin and Provera would be history in light of their perks: 26 percent increase in breast cancer, 41 percent increase in strokes, 29 percent increase in heart attacks, 22 percent increase in cardiovascular disease, double the rates of blood clots and links to deafness, urinary incontinence, cataracts, gout, joint degeneration, asthma, lupus, scleroderma, dementia, Alzheimer's disease and lung, ovarian, breast, endometrial, gall bladder and melanoma cancers -- pant pant. But you'd be wrong. Even as we speak, Pfizer-linked researchers are testing the cognitive and cardiovascular "benefits" of hormone therapy, in some cases with our tax dollars, at major universities. Even though the cancer rate in the U.S. and Canada fell when women quit hormone therapy in 2002 (as did the U.S. heart attack rate in women), pharma is rolling out HT "Light" for women who suffer from the "ism" of incredibly short memory.

Thursday, April 15, 2010

Bayer: "No Way to Stop the Uncontrolled Spread of its Genetically Modified Crops"

Bayer admits GMO contamination out of control
Published on 04-15-2010

Drug and chemical giant Bayer AG has admitted that there is no way to stop the uncontrolled spread of its genetically modified crops.

"Even the best practices can't guarantee perfection," said Mark Ferguson, the company's defense lawyer in a recent trial.

Two Missouri farmers sued Bayer for contaminating their crop with modified genes from an experimental strain of rice engineered to be resistant to the company's Liberty-brand herbicide. The contamination occurred in 2006, during an open field test of the new rice, which was not approved for human consumption. According to the plaintiffs' lawyer, Don Downing, genetic material from the unapproved rice contaminated more than 30 percent of all rice cropland in the United States.

"Bayer was supposed to be careful," Downing said. "Bayer was not careful and that rice did escape into our commercial rice supplies."

The plaintiffs alleged that in addition to contaminating their fields, Bayer further harmed them financially by undermining their export market. When the U.S. Department of Agriculture announced the widespread rice contamination, important export markets were closed to U.S. producers. A report from Greenpeace International estimates the financial damage of the contamination at between $741 million and $1.3 billion.

Bayer claimed that there was no possible way it could have prevented the contamination, insisting that it followed not only the law but also the best industry practices. The jury disagreed, finding Bayer guilty of carelessness in handling the genetically modified crops. The company was ordered to pay farmers Kenneth Bell and Johnny Hunter $2 million.

"This is a huge victory, not only for Kenny and me, but for every farmer in America who was harmed by Bayer's LibertyLink rice contamination," Hunter said.

According to Hunter, the company got "the wake-up call they deserved."

Bayer is still being sued by more than 1,000 other farmers from Missouri, Arkansas, Louisiana, Mississippi and Texas.