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30 avril Merck 15 Days from ShutdownFinally, someone at the FDA grows a spine. Let's hope this is a trend.
FDA warns Merck to clean up violations at vaccine plant
By LINDA A. JOHNSON, AP Business Writer Wed Apr 30, 11:58 AM ET TRENTON, N.J. - The Food and Drug Administration is warning drugmaker Merck & Co. to fix problems at its main vaccine plant. The agency on Wednesday released a warning letter sent to Merck's chief executive that says FDA inspectors determined manufacturing rules are not being followed at the plant in West Point, Pa., just outside Philadelphia. The plant makes a number of popular children's vaccines, as well as Gardasil, which protects against cervical cancer. Last year, it recalled 1.2 million vaccine doses because of a sterility problem. The nine-page warning letter gives Merck 15 days to tell the FDA how it will correct the violations. Otherwise, the FDA says it could suspend the plant's manufacturing license and seize products. Merck Vaccine Kills ... But Docs Can Get 2 Percent Back If They Buy More Now!This isn't a surprise, really, but it's incredibly sad. Merck's rotavirus vaccine (RotaTeq, brought to you by Paul Offit) has just killed someone via intussusception (bowel obstruction). It's not a surprise because Wyeth stopped making its rotavirus vaccine (RotaShield, also brought to you by Paul Offit) because it killed too many people (via, you guessed it, intussusception). Rotavirus is very rare in the US and almost never results in fatalities (65 last year nationwide, I believe). It's a problem in developing countries without access to clean water, because it is spread through the fecal-oral route (not airborne). Still, Merck and the CDC are forcing it down our kids' throats. I hope Merck chokes on this news.
If you read this post (or perhaps the related Wall Street Journal article) and were surprised by it, then you obviously need to read some of my previous posts:
Merck’s fish kill in the Delaware: http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!213.entry
Merck’s Gardasil deaths: http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!185.entry http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!180.entry
Big Pharma’s PAC contributions: http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!183.entry http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!182.entry
Merck’s MMR (mumps, specifically) foibles: http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!178.entry
Merck’s HiB contamination: http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!177.entry Merck & Co Inc Update: FDA reports a death after vaccination with Rotateq - death from intussusception (bowel obstruction) will be added to prescribing information for doctors
[MRK] Today 10:54am Merck & Co Inc FDA warning letter will not hamper ability to sell currently marketed vaccines - wire headline - Merck notes that the FDA letter involves 12 remaining quality control observations from 49 original more...
[MRK] Today 10:03am Merck & Co Inc FDA sends warning letter about vaccine production at Pennsylvania plant - Inspectors note they found significant objectable conditions at the Merck plant.
[MRK] Yesterday 06:20am Merck & Co Inc Price target cut to $53 from $58 at Lehman 27 avril Wal-Mart To Stop Selling Bisphenol A (BPA)This is great news! Wal-Mart, retailing giant, is going to stop selling baby products with bisphenol A (BPA) in them. Bisphenol A is a known endocrine disruptor that greatly increases your chance of developing (for example) breast cancer. Toys R Us, as I reported earlier, has already pledged to stop selling BPA products by the end of 2008, and Health Canada is on the verge of banning BPA in Canada. The US FDA is, of course, dragging its feet, because the people who make these products (Philips, maker of Avent, I'm looking at you!) pay lots of taxes and probably spend lots of money on lobbying. What I love is that ABC News reports this story as "debate rages over plastic bottle chemical's safety." How hilarious! Scientists say it causes cancer, and companies that make it say that it's safe to use. Is that really a debate? I'm sure Saddam Hussein used to say that gassing Kurds to death was a good thing for Iraq--would we really call that a "debate" as to whether Saddam was a good leader? ABC News, the Al-Jazeera of the US, probably would. Quote
Pampers, UNICEF, and You -- Giving African Babies Autism TogetherYou've probably seen the ads--buy a pack of Pampers, save a child's life. Here's how it works: you buy a pack of Pampers, and Pampers donates money to UNICEF's fund for vaccinating "at-risk" pregnant women in developing countries. What you don't know is that the vaccines that we give people in developing countries are the ones that we won't allow our own children to take--yes, that's right, the ones with mercury (thimerosal) in them. If you don't believe me, check the CDC's list of contaminants and read about Td (Decavac and Massachusetts labels), which is the tetanus and diphtheria vaccine: http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-1.pdf http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf Now check the FDA's full list of all vaccines manufactured (http://www.fda.gov/cber/vaccine/thimerosal.htm#t1) , and keep in mind the frequent statement that "Today, with the exception of some flu vaccines, none of the vaccines used in the U.S. to protect preschool aged children against 14 infectious diseases contain thimerosal as a preservative" (http://www.cdc.gov/vaccinesafety/concerns/thimerosal_faqs_thimerosal.htm#4). Note that "TT" (which is the standalone tetanus vaccine) still contains thimerosal--25 micrograms of mercury per dose! Yeah, we're totally OK with poisoning foreigners--just like we're OK with them plowing under their own food crops to grow corn to sell us ethanol. If you're NOT OK with giving mercury poisoning to African babies, then consider Seventh Generation diapers, which are chlorine-free (http://www.diapers.com/Shop/Brands.aspx?CategoryID=1&CategoryName=DIAPERS&BrandCode=7thG&BrandName=Seventh%20Generation) or Tushies diapers, which are polyacrylamide gel-free (http://www.diapers.com/Shop/ProductDetail.aspx?ProductID=5468&From=Brand). The problem with "life-saving" programs like the one from Pampers and UNICEF is that they're cheap. It takes more than buying the diapers you were going to buy anyway to fix the problems of developing countries. It takes big money--and I'm looking at you, celebrity spokesperson Salma Hayek and big corporation Procter & Gamble--the kind of money that can build a hospial in Africa and staff it with doctors to treat diseases, or the kind of money that can put in modern plumbing and sewage so that the "flying toilet" phenomenon (http://en.wikipedia.org/wiki/Flying_toilet) becomes a thing of the past--along with the diseases that accompany it. Have some guts and pony up the real dough, and if you're a regular Joe who can't afford to make a donation that can really help, for God's sake don't give Africa new problems like autism. Quote Vaccines for Pregnant Women Provided by Pampers® and UNICEF 26 avril Autism Risk Linked To Distance From Power Plants, Other Mercury-releasing SourcesMore evidence against environmental mercury... Quote
25 avril Merck Vaccines Contaminated ... AgainCheck out the graphic below: Note that nearly $1.5 BILLION of Merck's money came from Gardasil in 2007--thank God for Texas and mandatory vaccination, right, Merck? Also note that Merck made 18% of its money from vaccines in 2007, up from 5% in 2005. Anyone (NY Times, I'm looking at you) who discounts Jenny McCarthy's opinion in favor of these jerks doesn't know how powerful a motivator money can be. Quote
The Next Hannah PolingWell, look at that. Another one of the kids suing the Department of Health and Human Services has a mitochondrial disorder. It turns out that the current vaccine schedule (including the insanity of the "catch-up" schedule) is grossly unsuited to a significant percentage of children and can send them into regressive autism. Wake up, Julie Gerberding! It's time to do what's right for the next generation of children. Quote
24 avril Aluminum, everyone's second-favorite neurotoxinAs I've mentioned before on this blog, aluminum is linked to Alzheimer's disease and may be implicated in other neurological disorders. It's definitely not something you want in your body. So how does it get there, and what are the alternatives to the poisonous products you're likely to find in your home? - Baking powder and baking soda: sodium aluminum phosphate is used as an anti-caking agent. Calcium phosphate is non-toxic, but more expensive, so most brands don't use it. Try Bob's Red Mill (www.bobsredmill.com) for the good stuff. - Antiperspirant: aluminum makes you not sweat. Think about it, though: would you rather be a little sweaty, or have Alzheimer's disease? Try Herbal Clear (www.herbalcleartoxicfree.com, also available on www.amazon.com) for a deodorant without aluminum, parabens, or propylene glycol. - Cookware: many pots and pans are made of aluminum, which leaches into food when it's cooked. Try cast iron or stainless steel instead. - Vaccines: aluminum is used as an adjuvant. Not sure if there's any alternative to this one, which is why we all need to show up at Jenny McCarthy and Jim Carrey's "Green the Vaccines" rally in Washington, DC, on June 4th. Quote http://www.bobsredmill.com/ 22 avril Pneumonia vaccine causes rise in pneumonia in ScotlandSo you vaccinate against a few strains of pneumonia, and then the other strains get more powerful, and they come and get you. Brilliant! Vaccinating for pneumonia is one of the dumbest ideas I've ever heard. This (http://www.youtube.com/watch?v=zDkothz4lV4) is a much better idea:
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Toys R Us Bans BPAThe FDA doesn't care. They say they're not sure Bisphenol A (a known endocrine disruptor) is bad for you. The major baby bottle makers don't care. They say they're only selling something that is FDA-approved. (Avent "Naturally," I'm looking at you!) It's up to the consumers and the channel (bravo, Toys R Us!) to keep these cancer-causing plastics from our kids. I like that Toys R Us is getting rid of BPA bottles by the end of the year, even though manufacturers like Avent (http://www.aventamerica.com/support/tipsfaqs/bottlefeeding.asp#bisphenola) are clinging to the FDA's November 2005 claim that BPA is safe. How totally lame that Avent (and parent comparny Philips) can't just get its act together and make a safe product like the one from Born Free (www.newbornfree.com) or Foogo (http://www.thermos.com/SubCategoriesCatalog.aspx?CatCode=Foog&SubMenuID=0)? How hilarious that Avent feels the need to assert, "Our products have been and will continue to be used by millions of healthy babies in over 70 countries worldwide." Not in Canada, and not at Toys R Us, they won't. Let's watch the rest of the dominos fall. Quote
21 avril Canada Proposes Banning Bisphenol-A Baby Bottles...... while the US FDA sits on its ass. Nalgene is voluntarily withdrawing its product from the market--thank God some manufacturers have more spine than our government does. Quote
18 avril Standing Orders from the Immunization Action CoalitionRead these PDFs. They are un-****-ing-believable. They are standing orders to doctors, nurses, and pharmacists to give infants immunizations with or without parents' consent for no reason other than to give money to pharmaceutical companies. For example, read the one for Hep B. Read the guidelines for babies born to mothers who are HEP B NEGATIVE. Read where it tells nurses to give baies who weigh 4.4 POUNDS a full dose of Hep B vaccine before they leave the hospital, even if their mothers DO NOT HAVE HEP B, which is a blood-borne pathogen. Then ask yourself who the "Immunization Action Coalition" is. I'm glad you asked. It's a couple of doctors at some hospital in Minnesote acting as a mouthpiece for Big Pharma (see "IAC Funding," on this page: http://www.immunize.org/aboutus/funding.asp where the following donors are listed: Merck, Sanofi Pasteur, Wyeth, MedImmune, and Baxter). It's also a direct line from Big Pharma to the CDC to your doctor. Big Pharma pays the IAC. The IAC develops "standing orders" (like the one telling nurses to give Hep B shots to 4.4-pound preemies born to Hep B-negative mothers) for use in hospitals. The CDC promulgates these standing orders, urging physicians to use them (see the "Recommendations" section here: http://cdc.gov/vaccines/vpd-vac/rotavirus/default.htm#concerns). Your physician, who is basically someone who can memorize well (because that's what gets you through medical school--not intellect or ingenuity), forces your kid onto a ridiculous immunization schedule, often against your will or without your full knowledge or consent. It's time to Just Say No. Try this thought experiment: Imagine if ArmaLite (who makes guns) gave money to me and a friend of mine. Then my friend and I wrote up some PDFs called "Standing Orders to Defend Your Liberty" stating that every high school principal should give every high school senior a rifle upon graduation. Then the Department of Education promulgated my PDFs to all high school principals everywhere. Then all high school principals everywhere gave rifles to all high school seniors everywhere, resulting in big profits for ArmaLite (and--coincidentally? who knows?--a skyrocketing of the teenage murder rate). You would be horrified. Horrified. That's how you should feel about Immunize.org, the CDC, and the whole Big Pharma shell game. Quote Educational Print Materials from IAC: Standing Orders Great New Book from Deirdre Imus: Growing Up Green: Baby and Child Care: Volume 2 in the Bestselling Green This! Series $GLots of great info on safe and green ways to raise your child, from pregnancy through adolescence. Wyatt Imus is lucky to have such a great mom. Check out this book for information on why you should avoid fish, cleaning products to use (and those to avoid), and why not to give your kid tons of plastic junk to chew on and play with. I live a pretty green life, but this book had plenty of information in it that I didn't already know. Quote
9 avril Vaccinations Cause DiabetesJust in case you weren't sure whether it's a good idea to overstimulate the immune system, here's more evidence that it's not.
Discontinuation of BCG Vaccination Precedes Significant Drop in Type 2 Diabetes in Japanese Children. Role of Inflammation and Cortisol Activity as a Cause of Type 2 Diabetes pp.1-4 (4) Author: John B. Classen
doi: 10.2174/1874216500802010001
Abstract: BCG immunization was routinely given to elementary and junior high school students in Japan until it was abruptly discontinued after 2002. Data on the incidence of type 2 diabetes was analyzed to see if there was a change following discontinuation of BCG. The incidence of type 2 diabetes dropped by over 50% in children from Tokyo following discontinuation of BCG immunization, the relative risk reached 2.78 (95% confidence interval 1.03 - 7.480). This drop appears to be more significant given the epidemic of type 2 diabetes in children around the world. The increased secretion of cortisol following immunization is thought to result in metabolic syndrome and type 2 diabetes. Japanese children produce larger amounts of cortisol following immunization than White children. This increased production of cortisol may explain why Japanese children have a high risk of type 2 diabetes but low risk of type 1 diabetes compared to White children. The proposed mechanism may explain the epidemic of obesity which starts in children under 6 months of age. Hope You Didn't Need Any Heparinhttp://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/2008/heparin_nth-aah_e.html
The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
NOTICE TO HOSPITALS Health Canada Issued Important Safety Information on HEPARIN
March 27, 2008
To: Hospital Chief of Medical Staff
Please distribute to the relevant Departments of Pharmacy, Surgery, Emergency Medicine, Pediatrics, Geriatrics, Internal Medicine, Intensive Care, Nephrology and Dialysis Units and other involved professional staff and post this NOTICE in your institution.
Subject: Contaminant associated with serious allergic adverse reactions in the United States found in some Canadian HEPARIN products
As per the advisory posted on Health Canada MedEffect's website on March 20, 2008, Health Canada's testing of heparin has identified the presence of a substance similar to the contaminant, oversulphated chondroitin sulphate, identified by the FDA, in some lots of the active pharmaceutical ingredient of heparin from B. Braun Medical Inc. In the US, use of heparin products contaminated with oversulphated chondroitin sulphate has been associated with an increase in reported serious allergic and anaphylactic reactions and possible lack of effect. B.Braun is recalling the affected lots of unfractionated heparin for intravenous use on the Canadian market.
Health Canada testing of other heparin products available in Canada is ongoing. Health Canada is requiring all Canadian distributors and manufacturers of heparin to implement additional tests in all lots of heparin active pharmaceutical ingredient. Pending results, regulatory action will be taken as appropriate. Health Canada will continue to inform health care providers and the public as soon as new information becomes available, please monitor our website for updated information.
Health Canada is recommending the following:
Ensure that the recalled lots of B. Braun Medical Inc's unfractionated heparin for IV injection are not used and are returned as instructed in the company's recall letter. Other unfractionated heparin products for IV use are available;
Use the lowest dose necessary at the slowest infusion rate acceptable to obtain the desired effect;
Administer infusions without using a bolus dose whenever possible;
Carefully monitor patients during and immediately following heparin administration for signs of allergy or anaphylactic reaction;
Monitor anticoagulation parameters as the possible presence of a contaminant may affect the efficacy of the product;
Ensure that this information is communicated accordingly if you are aware of any use of the above recalled products outside the hospital setting.
Background On January 18, 2008, Baxter Healthcare and the U.S. FDA notified American healthcare professionals of a recall of all of their multi-dose and single-use vials of heparin, due to an increase in reports of allergic adverse reactions. The last reported number in U.S. is approximately 785 adverse reactions and 19 deaths associated with use of certain heparin lots in which the contaminant was found. FDA revealed that the contaminant is a substance called oversulfated chondroitin sulfate. However, the causality between the contaminant and the adverse reactions has not been established. Consult the US FDA.
Adverse reactions reported to Health Canada do not show an increase in allergic reactions related to heparin in 2007. In Canada, there was only one report of an allergic adverse reaction related to heparin from January 1, 2007 to March 6, 2008.
The identification, characterization, and management of marketed health product-related adverse reactions are dependent on the active participation of health care professionals in adverse reaction reporting programmes. Any occurrences of allergic/anaphylactic reactions or other serious and/or unexpected adverse reactions in patients receiving heparin should be reported immediately to Health Canada at the following address:
Any suspected adverse reaction can also be reported to: Canada Vigilance Program Marketed Health Products Directorate HEALTH CANADA Address Locator: 0701C Ottawa, Ontario, K1A 0K9 Tel: 613-957-0337 or Fax: 613-957-0335 To report an Adverse Reaction, consumers and health professionals may call toll free: Tel: 866 234-2345 Fax: 866 678-6789 CanadaVigilance@hc-sc.gc.ca
The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.
For other inquiries related to this communication, please contact Health Canada at: Bureau of Cardiology, Allergy and Neurological Sciences (BCANS) E-mail: bcans_enquiries@hc-sc.gc.ca Telephone: 613-941-1499 Fax: 613-941-1668
8 avril What Big Tobacco and the Gunmakers Could Learn from Big PharmaHow to bribe government officials, I think. What else could explain the fact that the Supreme Court seems likely to give pharmaceutical firms pre-emption--a legal term for "you can't sue us"--because the FDA approves all pharmaceutical products in the marketplace? Let's just ponder a few facts here, shall we? 1. All companies, other than non-profits, exist to make money. If you're not the Peace Corps or Legal Aid, you exist to make money, no matter how enjoyable or helpful your product(s) may be. Merck is in business for the same reason as R.J. Reynolds and ArmaLite. 2. All cigarettes have carried the warning of the Surgeon General since 1969, but are sold legally in the United States. Despite this message of "OK, go ahead" by the US government, cigarette companies were sued for cigarette-related health care costs, and settled--to the tune of 246 BILLION DOLLARS--in 1998. (See here: http://www.cbsnews.com/stories/2006/03/09/business/main1384910.shtml) 3. According to the press, cigarette companies funded the 246 BILLION DOLLAR settlement by raising prices on cigarettes--which are paid for by smokers, not all Americans. Again according to the press, these higher prices are causing a drop in cigarette sales; thus, FEWER PEOPLE ARE SMOKING or PEOPLE ARE SMOKING LESS. 4. Pharmaceutical firms have already won pre-emption in the case of vaccine injuries. Individuals who are injured by vaccines are forced to seek remedy in the US Court of Federal Claims, where the defendant is the Secretary of Health and Human Services. This means that every payout to a vaccine-injured individual is FUNDED BY TAXPAYERS. That's right, EVERY AMERICAN PAYS when Big Pharma's vaccines harm someone. 5. Cigarettes carry a "black box" warning label that they are hazardous to your health, may cause cancer, etc. Cigarettes are restricted for sale to adults. Cigarettes carry a huge price tag, none of which can be reimbursed by insurance (of course). 6. Vaccines are MANDATORY for entrance into public school (unless an individual obtains a medical or religious exemption, which are rare--only 2.5% of children currently have these exemptions). Vaccines are covered by health insurance. Therefore, 97.5% of American children buy vaccines, and EVERY HEALTH INSURANCE PLAN MEMBER PAYS FOR THEM. 7. Big Pharma's other products (besides vaccines) harm and kill people. Ortho Evra alone has killed 23 people since 2002. (See here: http://orthopatchlawsuit.lawinfo.com/contact-an-ortho-evra-lawyer.html) Big Pharma lies about the content of its products (see the NYT article below) and about their efficacy (see here: http://www.nj.com/business/ledger/index.ssf?/base/business-1/1203226564272060.xml&coll=1). The FDA is not doing a good job protecting the public from harmful drugs, but NEITHER IS BIG PHARMA. Now ask yourself whether pharmaceutical firms deserve pre-emption for all their products. It just doesn't make sense. Pre-emption means that you, the taxpayer, will cover the cost of all drug injuries and deaths. You already cover the costs of vaccine injuries (through your tax dollars). You already cover the cost of everyone's drugs and vaccines (through your insurance company premiums). Should you really cover ALL of their legal costs? Here are a couple more facts to help you decide: 8: Leaders in Market Capitalization JOHNSON AND JOHNS DC [JNJ]: $186.2 B PFIZER INC [PFE]: $144.3 B GLAXOSMITHKLINE PLC [GSK]: $121.8 B NOVARTIS AG ADS [NVS]: $118.0 B SANOFI-AVENTIS SA [SNY]: $102.6 B MERCK CO INC [MRK]: $86.6 B ABBOTT LABORATORIES [ABT]: $84.8 B ASTRAZENECA PLC ADS [AZN]: $61.3 B LILLY ELI CO [LLY]: $59.4 B WYETH [WYE]: $55.6 B
9. These aren't even all American companies. Do you like seeing your tax dollars and health insurance premiums go to Switzerland? Neither do I. April 6, 2008
Drug Makers Near Old Goal: A Legal ShieldBy GARDINER HARRIS and ALEX BERENSON
For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents. But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released. This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say. The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted. More than 3,000 women and their families have sued Johnson & Johnson, asserting that users of the Ortho Evra patch suffered heart attacks, strokes and, in 40 cases, death. From 2002 to 2006, the food and drug agency received reports of at least 50 deaths associated with the drug. Documents and e-mail messages from Johnson & Johnson, made public as part of the lawsuits against the company, show that even before the drug agency approved the product in 2001, the company’s own researchers found that the patch delivered far more estrogen each day than low-dose pills. When it reported the results publicly, the company reduced the numbers by 40 percent. The F.D.A. did not warn the public of the potential risks until November 2005 — six years after the company’s own study showed the high estrogen releases. At that point, the product’s label was changed, and prescriptions fell 80 percent, to 187,000 by last February from 900,000 in March 2004. Gloria Vanderham, a Johnson & Johnson spokeswoman, said the company acted responsibly. “We have regularly disclosed data to the F.D.A., the medical community and the public in a timely manner,” Ms. Vanderham said. “Ortho Evra is a safe and effective birth control option for women when used according to the labeling.” But Janet Abaray, a plaintiff’s lawyer from Cincinnati, said that Johnson & Johnson took advantage of an agency overwhelmed by its many responsibilities. “Johnson & Johnson knew that F.D.A. does not have the funding or the manpower to police drug companies,” Ms. Abaray said. A series of independent assessments have concluded that the agency is poorly organized, scientifically deficient and short of money. In February, its commissioner, Andrew C. von Eschenbach, acknowledged that the agency faces a crisis and may not be “adequate to regulate the food and drugs of the 21st century.” The F.D.A. does not test experimental medicines but relies on drug makers to report the results of their own tests completely and honestly. Even when companies fail to follow agency rules, officials rarely seek to penalize them. “These are scientists, not cops,” said David Vladeck, a professor at Georgetown Law School. Last month, at a trial over the schizophrenia drug Zyprexa, Dr. John Gueriguian, a scientist who worked at the F.D.A. for two decades, testified that the agency did not always ask for strong warnings even if it believed a drug was risky. Companies typically oppose warnings, and the agency knows it must compromise on its requests or face years of delay, Dr. Gueriguian said. “We at the F.D.A. know what we can obtain and we cannot obtain,” Dr. Gueriguian said. “We have many, many problems, and we have a management system — what we can’t obtain we will not ask.” For years, top officials at the agency acknowledged that lawsuits could aid the agency’s oversight of safety issues. In the last decade, suits over Zyprexa, the withdrawn pain pill Vioxx, the withdrawn diabetes medicine Rezulin, the withdrawn heartburn medicine Propulsid and several antidepressants have shown that companies played down the risks of their medicines and failed to disclose clinical trials to the public even as they have aggressively marketed their drugs. But now, the agency says a proliferation of lawsuits could lead to an overlapping patchwork of rules that would burden companies and might discourage patients from taking useful medicines. The Ortho case, however, suggests that Johnson & Johnson, like other drug makers, is not always quick to tell the F.D.A. about potential problems with its medicines. In 1996, the company told the agency it planned to develop the Ortho Evra patch in part because it would be likely to expose women to less estrogen than pills. The company suggested that the body would not break down hormones delivered via the patch as readily as the pill, so lower doses could be used to achieve contraception. And unlike the pill, which must be taken daily, the patch is changed weekly. High doses of estrogen are known to raise the risk for blood clots that can cause heart attacks and strokes. But a crucial trial completed in 1999 showed that the patch delivered 30 to 38 micrograms of estrogen into the bloodstream each day, according to company documents. Because up to half of the estrogen in pills is lost in the digestive tract before it reaches the blood, the study suggested that the patch delivered an amount of estrogen that could be as high as a pill containing 76 micrograms of estrogen. In 1988, the F.D.A. banned birth control pills with more than 50 micrograms of estrogen. But the study’s author, Dr. Larry Abrams, who has since retired from Johnson & Johnson, decided to apply a “correction factor” to the results of the 1999 trial, according to documents. He claimed that the patch actually delivered about 40 percent less estrogen than the trial results showed — about 20 micrograms a day. Dr. Abrams made the change, according to his deposition, to adjust for the different ways the body metabolizes hormones from pills and patches. This adjustment was never part of the study protocol, a plan filed with the F.D.A.. “The judgment was made by the pharmacokeneticists at the time that in doing the calculation, it was probably appropriate to make that correction,” Bob Tucker, a lawyer representing Johnson & Johnson, said in an interview Thursday. “Later on when people looked at it in a different time frame, they concluded that probably the correction shouldn’t be applied.” The company mentioned its decision to use the “correction factor” only once in a 435-page report filed with the F.D.A., and then only in a complex mathematical formula. When the study was published in 2002, there was no reference to the alteration. Mr. Tucker said that the F.D.A. was aware of the “correction factor.” Clinical trials conducted before the patch was approved raised other red flags, as patients complained of breast soreness and nausea. “The side effects seem related” to high estrogen doses, one company scientist wrote in an e-mail message. Two other studies, one conducted in 1999 and another in 2003, confirmed that the patch released more estrogen than the pill. Still, Johnson & Johnson delayed reporting those results to the food and drug agency, according to documents that have been made public in lawsuits. After the patch was approved, the company marketed it as releasing 20 micrograms of estrogen to the blood every 24 hours, a figure it now acknowledges was inaccurate. It also acknowledges that the patch releases more estrogen than the pill but says that the estrogen released under the two methods cannot be directly compared. The New York Times provided the drug agency with a copy of a court brief and asked whether agency medical reviewers were aware of the “correction factor.” Rita Chappelle, an F.D.A. spokeswoman, replied, “At present, we are reviewing the allegations and cannot comment further at this time.” Prescriptions for the patch grew rapidly after its introduction, reaching more than 900,000 by March 2004, according to data from Wolters Kluwer, a company that tracks prescription trends. But as the use of the patch rose, so did reports of side effects. By 2004, after the death of Zakiya Kennedy, an 18-year-old college freshman in New York, food and drug officials had become concerned. In November 2005, the agency announced that it had placed a warning that the patch “exposes women to higher levels of estrogen than most birth control pills.” Since then, an epidemiological study has shown that women on the patch can have as much as double the risk of blood clots than those taking pills. And prescriptions for the patch have fallen 80 percent. Still, lawyers for Johnson & Johnson say that patients should not be allowed to sue the company because the F.D.A. approved the patch and its label. “F.D.A. is responsible for making those decisions,” said John Winter, a lawyer for the company. Judge David A. Katz of Federal District Court for the Northern District of Ohio is expected to rule soon on whether any of the lawsuits against Johnson & Johnson can go forward. In the fall, the Supreme Court will hear a separate pre-emption case involving Wyeth, another drug company. Chris Seeger, a plaintiffs’ lawyer who has about 125 Ortho Evra cases, said he expected the court to rule in Wyeth’s favor. “Our lawsuits are the ultimate check against the mistake made by the government, or fraud made by the companies against the government, or just an underfunded bureaucracy stretched thin,” he said. Janet Roberts contributed reporting. 7 avril No-VOC PaintWe just bought a house, and we'll be doing some painting with this:
FreshAire paint, available at Home Depot, has no VOCs in the paint or in the colorant.
GreenDepot stores sell other no-VOC brands, but they're not in every town. Benjamine Moore makes a paint called EcoSpec with no VOCs, but it's not available near us. Artificial food colors and preservatives bad for kids......and probably not great for adults. Just say, "No" to anything not colored with annatto or other natural colors.
http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2008/04/07/nfood107.xml
Artificial colourings as harmful as leaded petrol for children By Graham Tibbetts Last Updated: 2:45am BST 07/04/2008
Artificial colourings could be removed from hundreds of food products after researchers found that they may be almost as harmful to children's development as leaded petrol.
The additives, found in a host of sweets and soft drinks, have been linked to behavioural problems. But a team at Southampton University, carrying out a £750,000 study for the Food Standards Agency, (FSA) suggested seven colourings, including tartrazine and sunset yellow, could also affect children's intelligence by up to five IQ points.
The board of the FSA, the industry's governing body, will meet on Thursday to consider recommendations from its officials that manufacturers should voluntarily remove six of the E numbers from their products while further research is carried out on the seventh, sodium benzoate. They would be urged to use natural replacements.
The Southampton study was published in September but the FSA ignored calls for swift action after the Committee on Toxicology said additives had only a moderate effect on some children.
Claims that the colourings were virtually as damaging as lead emerged when the leader of the research, Professor Jim Stevenson, wrote to the FSA demanding immediate action.
"The position in relation to AFCs [artificial food colours] is analogous to the state of knowledge about lead and IQ that was being evaluated in the early 1980s... Needleman [a researcher] found the difference in IQ between high and low lead groups was 5.5 IQ points... This is very close to the sizes obtained in our study of food additives," wrote Professor Stevenson.
Leaded petrol was phased out from petrol stations in 2000, two decades after the warning. The letter added: "We would argue that the findings from our own study... would lead to the same conclusion... that there is 'justification for action now'."
The letter was sent to the FSA last month and published at the end of last week.
A spokesman for the Food and Drink Federation, which represents the industry, said that food additives were properly tested before they were allowed to reach the public.
"The use of food additives is strictly regulated under European law and they must be approved as safe by the appropriate European scientific committee before they can be used..."
The additives linked to hyperactive behaviour are:
• Tartrazine (E102): Yellow food colouring found in mushy peas and candy floss, banned from all foods and drinks for under-threes.
• Quinoline yellow (E104): Food colouring found in squash, flu capsules
• Sunset yellow (E110): Orange yellow colouring found in bubble gum and jelly babies.
• Carmoisine (E122): Red food colouring found in throat lozenges
• Ponceau 4R (E124): Red food colouring found in pear drops and bombay mix
• Allura red (E129): Red food colouring found in fruit jelly sweets and lollipops.
• Sodium benzoate (E211): Artificial preservative found in squash, fizzy drinks and cough syrup
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