Wednesday, December 1, 2010
thebendictinedefects: Exit Thalidomide enter Bendectin
Thursday, November 25, 2010
Revolt Against the Pesticide Empire
- stop buying these corporations' products;
- don't buy their stock on whatever exchanges they're traded;
- demand that others including institutions sell their stock in these companies;
- don't work for these corporations;
- find a way to personally pass on the word.
- Dow
- Du Pont
- Monsanto
- Imperial Chemical Industries
- Novartis
- Rhone Poulenc
- Bayer
- Hoechst
- boycotting the hell out of it as described above;
- and then developing real alternatives for their toxic products.
If you think I'm exaggerating in estimating how far multinationals will go in trying to peddle their toxins, meditate on the fact that the completely discredited and horrible drug, Thalidomide, a sedative that caused massive deformation in babies, is now being tested on people with AIDS.
Dow and Monsanto would still be selling their stocks of Agent Orange left over from the Vietnam War if enough people hadn't kept up a thunder of protest about dioxin, the molecule this defoliant contained which causes cancer, birth defects and immune suppression, and is called by scientists the most poisonous small molecule on the planet.
So the answer to a monopoly is: boycott it and lay down real alternatives to the needs it pretends to fill.
The way things look, unless we launch a major effort our human societies in the 21st Century are going to disappear up their own anuses. If that's too graphic for you, take a look some time at Rocky Flats, Colorado, world center for poisonous leaking chemicals; or look at a baby deformed by these chemicals. That's what graphic really is. Steady state politeness and niceness are not going to carry the day. Don't knuckle under. Don't believe liars. Don't march off the cliff. Boycott!
Dow
Number two in chemical sales in the U.S. Employees: 58,000. Sales: $20 billion. Headquarters: Midland, Michigan, U.S.Dow, the manufacturer of Napalm and Agent Orange during Vietnam War, and now the target of a billion dollars worth of lawsuits over their highly destructive silicone breast implants, is partners with the drug firm Ely Lilly in Dow Elanco, a spin-off company that is the largest producer of insecticides and fungicides in the U.S.
Dow must have a magnetic attraction for severe defoliants. Having distanced itself from Agent Orange -- its partner Lilly now makes Tebuthiuron, an herbicide that kills soil so that no plants can grow on it in the future. Sounds like a weapon of war.
Of course Dow also tries to distance itself from dioxin (contained in its Vietnam era Agent Orange), but Greenpeace reports that hugely produced chlorine based Dow products -- pesticides, solvents and PVC plastics -- are the single largest source in the world of dioxin today.
Dow owns Marion Merrell Dow (MMD), a major pharmaceutical house. Like all drug companies, whether you know it or not, the commercial output of MMD is chillingly toxic. Let's start there.
Examples:
- MMD's vaginal suppository AVC cream is used to treat Candida albicans. The PDR states that there is no data available on the long term potential of AVR for causing cancer or birth defects, but "deaths associated with administration of oral sulfonamides (such as AVC) have reportedly occurred form hypersensitivity reactions, agranulocytosis, aplastic anemia and other blood discrasias." . . . Comforting.
- Bentyl, Dow's drug for irritable bowel syndrome, also has in the PDR listing "no known data" for long term potential carcinogenicity or birth defects, but "psychosis has been reported in sensitive individuals." There are also, the PDR says, reports of deaths from respiratory collapse.
- Cardizem, the Dow drug for hypertension and angina, carries the PDR caution: "Worsening of congestive heart failure has been reported in patients with preexisting impairment of ventricular function."
Here is a partial list of Clomid's post-marketing adverse effects:
- seizure
- stroke
- psychosis
- cataracts
- posterior vitreous detachment
- arrhythmia
- tachycardia
- hepatitis
- liver and breast and pituitary and ovarian and kidney and tongue and bladder cancer
- brain abscess
- tubal pregnancy
- uterine hemorrhage
- ovarian hemorrhage
- neuroectodermal tumor
- thyroid tumor
- leukemia
- abnormal bone development including skeletal malformations of the skull, face, nasal passages, jaw, hand, limb and foot joints
- malformations of the anus, eye, lens, ear, lung, heart and genitalia
- dwarfism
- deafness
- mental retardation
- chromosomal disorders
- neural tube defects
- Gastrointestinal bleeding
- vomiting
- low hemoglobin
- fetid sweat
- impotency
- anorexia
- diminished sense of taste and smell.
Some of the effects of Norpramin are:
- both elevating and lowering of blood sugar levels
- heart block, myocardial infarction, stroke
- sudden death
- hallucinations, delusions
- tremors, ataxia, peripheral neuropathy, seizures
- dilation of urinary tract
- bone marrow depression
- vomiting, black tongue, hepatitis
- impotence, painful ejaculation, testicular swelling
- weight gain or loss.
Dow makes Rifadin, a "semi-synthetic" antibiotic for the treatment of tuberculosis. The PDR comments, "Rifadin has been shown to produce liver dysfunction. Fatalities associated with jaundice have occurred in patients with (previous) liver disease." The PDR further issues a bizarre warning -- "Rifadin can cause the urine, feces, saliva, sputum, sweat, and tears to turn red-orange. "Permanent discoloration of soft contact lenses may occur."
The suggested Rifadin dosage for people with TB is 600mg a day for six to nine months. Yet the PDR gives this warning: "High doses of Rifadin greater than 600mg given once or twice a week have resulted in high incidence of adverse reactions, including leukopenia (abnormal decrease in white blood corpuscles), thrombocytopenia (abnormal decrease in blood platelets), acute hemolytic anemia, shock, renal failure."
Among Rifadin's other adverse effects are anorexia, vomiting and menstrual disturbances.
Friday, September 17, 2010
(pieces of an article in NY Times)
In 1983, the morning sickness drug Bendectin was removed from the market amid a barrage of lawsuits claiming that it caused birth defects. Now, in what medical and legal experts say, is a shame that it may be brought back.
A small privately held Canadian company, Duchesnay Inc., is working with the Food and Drug Administration to gain permission to market a generic version of Bendectin, which it calls Diclectin. Duchesnay is already selling the drug, its only product, in Canada, labeling and marketing it specifically for pregnant women.
The company says -- and medical experts agree -- that dozens of studies, many prompted by the litigation, have failed to find that Bendectin poses any dangers to pregnant women or their fetuses. And the drug agency said that since Bendectin was withdrawn by its maker, independently of the agency, and was not withdrawn for reasons of safety or efficacy, it might not be difficult to bring it back.
Andrea C. Masciale, a lawyer for the agency, explained that all Duchesnay had to do was show the F.D.A. that its generic Bendectin was chemically the same as the original drug. No clinical studies or research are required, which simplifies the process of its reintroduction. ''We think they can achieve a product that is the same as Bendectin and therefore come in with a generic version of Bendectin,'' Ms. Masciale said.
The development has stunned medical and legal experts, who say that the possible Lazarus-like re-emergence of Bendectin is so bold and unprecedented that they are at a loss for comparisons.
For many drug companies, birth defect experts, obstetricians and law professors, the Bendectin story is unforgettable. Bendectin is the only drug withdrawn from the market solely because of litigation, said Jeffrey Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America. Even the United States Supreme Court eventually weighed in on the matter.
''Bendectin was the archetypical case of junk science scuttling a perfectly safe product,'' said Dr. Michael Greene, the director of maternal-fetal medicine at Massachusetts General Hospital in Boston.
But Prof. David Bernstein, a law professor at George Mason University in Virginia, said it was only a twisted sort of poetic justice to bring back Bendectin. ''There's no justice to the company who spent over $100 million in litigation, not to mention having their chief executives tied up in litigation for years and years,'' Professor Bernstein said.
By 1980, 10 percent to 20 percent of pregnant women in the United States were taking Bendectin. But soon afterward, as the lawsuits mounted, Bendectin became tainted like thalidomide, the sedative that caused horrific birth defects when women took it early in pregnancy.
Women who took Bendectin and had babies with birth defects, especially limb defects like missing fingers or missing bones from an arm or a leg, found it hard to believe scientists who said that such things simply happen by chance and that the millions of women who took Bendectin had no more children with birth defects than those who did not take the drug. One out of every 2,000 American babies born each year has a limb defect and about 2.5 percent of babies have birth defects. Yet even if Bendectin was safe, as its defenders argued, few women or their doctors wanted to use it.
Memories have faded over the decades. Now, doctors say, many of their pregnant patients have never heard of the drug. That means that if Bendectin does return, it may come in as a fresh product to a generation that has no prejudice against it, medical experts said.
Eric Gervais, Duchesnay's executive vice president, is optimistic that he will get the drug agency's approval to market his generic version of Bendectin. Mr. Gervais said he was confident that the drug would sell as well in the United States as it had in Canada. There, he said, each year the company sells 70,000 bottles of Diclectin, each containing 100 pills. ''North America is indeed in need of this product,''
Dr. Anthony Scialli, a professor of obstetrics and gynecology at Georgetown University School of Medicine, agreed. ''There's a huge amount of safety data on Bendectin,'' Dr. Scialli said. ''It was the best studied medication in pregnancy of all time -- not just for nausea and vomiting, but the best studied, period.''
And once it was withdrawn from the market, surrounded by accusations that it caused birth defects, he said, doctors became afraid to give pregnant women any medications to relieve nausea and vomiting. That, Dr. Scialli said, led to an unfortunate situation.
When Bendectin's maker, Merrell Dow, removed the drug from the market, it said it was doing so because the cost of defending itself against an avalanche of lawsuits was simply too great. It was not jury verdicts or punitive damages that took their toll but simply the expense of dealing with thousands of lawsuits, said one of the company's lawyers, Frank Woodside of Cincinnati. In fact, Mr. Woodside said, the company prevailed in court. ''We have never ultimately lost a case,'' he said.
Soon, even insurance for Bendectin became an issue, Mr. Woodside said. ''Before they finally pulled it off the market, the insurance was going to cost them more per year than the amount they sold -- not the profit but the amount they sold,'' he recalled.
The litigation eventually made legal history. Lawyers representing women who said the drug had damaged their children brought experts into court who, critics said, were not qualified to comment and were propounding what critics called junk science. In 1993, the Supreme Court ruled on the matter, concluding that judges are to act as gatekeepers and ensure that ''any and all scientific testimony or evidence admitted is not only relevant, but reliable.''
The result, some legal experts say, is that if Duchesnay does bring Bendectin back, it may be the drug maker least likely to be sued. Many judges have made it clear that they will no longer allow Bendectin cases in their courts.
''Unless there is new evidence supporting the causal relationship between Bendectin and birth defects, lawyers are going to be reluctant to bring cases because they will fear that judges won't allow their experts on the stand,'' said Michael Gottesman, a Georgetown law professor who argued for the Bendectin plaintiffs before the Supreme Court.
As for the drug's safety, Mr. Nace said, ''In my mind, there is no question that Bendectin causes birth defects.'' He added that every time he saw a young person with missing fingers or a shortened arm or club feet, he thought of the drug. ''I want to walk up to them and say, 'Did your mother take Bendectin?' '' he said.
While Mr. Nace says he shudders to think that Bendectin may return, obstetricians say they welcome it.
Dr. Charles Lockwood, chairman of the department of obstetrics and gynecology at New York University School of Medicine, said he had seen large numbers of pregnant women whose lives were made miserable by nausea and vomiting.
''We try all sorts of different remedies,'' Dr. Lockwood said. ''We've literally tried everything from acupuncture bands, which don't seem to work, to fairly aggressive medications that are psychoactive.'' For example, Dr. Lockwood said, he sometimes prescribed Reglan, a drug that controls nausea but also makes women drowsy. ''The amount you have to give to have an effect tends to make them sleepy all day long,'' he said.
Dr. Scialli said one of his pregnant patients recently got Bendectin from Canada because she was afraid to take other drugs whose safety in pregnancy had not been as well studied.
In desperation, a few doctors say they tell women essentially to make their own Bendectin. The ingredients, an antihistamine and vitamin B6, are available over the counter.
Tuesday, August 31, 2010
Exit Thalidomide enter Bendectin
Law suits
In 1980, Betty Mekdeci, head of the Association of Birth Defect Children in Orland, Florida, launched a most widely-publicized lawsuit against Merrell Dow over Bendectin. Her son was born with chest deformities, a shortened right arm and two fingers joined on his left hand, attributed to her use of the drug. A federal court in Orlando awarded $20,000 to the Mekdeci family who had sued for $10 million.
In July of this, a U.S. federal court ordered Merrell Dow to pay $20 million in compensation and $75 million in punitive damages, to Sekou Ealy, 8, after finding that his deformed arms were linked to his mother’s use of Bendectin during pregnancy.
“This is incredibly good news,” said Cate Sutherland, a Belleville-area woman whose child died at birth of severe heart defects. Mrs. Sutherland blames Bendectin (which she took during pregnancy) for her daughter’s death. “The incredibly large amount of punitive damages (awarded) shows the court is putting the blame on Merrell Dow” Cate affirms.
Mrs. Sutherland has been instrumental in bringing families from across Ontario together for a class-action suit against the drug maker. Since the fall of 1986, she has heard from 100 mothers who used Bendectin and whose children suffered birth defects.
Freely prescribed
At least 700 out-of-court settlements have been made by Merrell Dow, in the U.S. But Merrell Dow is no stranger to controversy. The company was associated with Thalidomide, an anti-morning sickness drug now proved to have caused many birth defects. Thalidomide was distributed in Canada under the brand name Kevadon, which was taken off the Canadian market in 1962.
In the early 1960s, Merrell Dow pharmaceuticals of Cincinnati developed Bendectin and successfully marketed it in the U.S., Canada, and across the world. An anti-nausea drug for pregnant women, it was freely prescribed by doctors and also sold over-the-counter for many years. An estimated 30 million women worldwide have taken the drug.
The anti-nausea drug contained doxylamine, a type of antihistamine, and pyridoxine, or vitamin B-6. (A third ingredient, dicyclomine hydrochloride, was dropped in 1979).
In 1983, Merrell Dow withdrew Bendectin voluntarily from the market, and a year later set up a $120 million fund for out-of-court settlements. Why? Because it is believed that Bendectin is responsible for causing birth defects in many children whose mothers have taken the drug, and the money would be needed to cover legal costs.
Dr. Stuart Newman, professor of anatomy at New York Medical College, is one developmental biologist who believes that Bendectin is linked to birth defects. “I am aware of studies that show that if Bendectin is present during the growth of cells that form limbs in experimental animals, it generally retards and inhibits the growth of the limb,” states Dr. Newman. While noting that the studies were in animals, not humans, professor Newman adds, “the drug is harmful to the cells for the development of limbs and that can lead to limb reduction.”
Interestingly, Dr. Newman says, the same antihistamine drug as that in Bendectin – minus the B-6 – is available over-the-counter in U.S. pharmacies today. It is called Unisom, and is sold as a sleep aid. It comes with a warning it is not to be used by pregnant women!
One Toronto pharmacist confirmed that a drug almost identical to Bendectin is still being sold in Canada. Diclectin, made by Laboratoire Duchesnay Inc., in Laval, Quebec, is available by prescription for relief of morning sickness. According to Duchesnay, president Pierre Boivin, Diclectin is taken by 8,000 – 10,000 pregnant women a year (about 375,000 babies are born in Canada annually). To date, this company has never been sued.