Big Pharma pushing off-label uses of their medication? Shocking! (What's actually shocking is that Lilly didn't wait until the patent for Zyprexa was about to expire, then try to extend it by producing a "new" drug to treat age-related dementia. Oh, wait, they would have had to TEST the drug on age-related dementia patients first. Oops.)
Eli Lilly considers $1 billion fine to settle U.S. case
By Alex Berenson
Thursday, January 31, 2008
Eli Lilly and U.S. prosecutors are discussing a settlement of a civil and criminal investigation into the company's marketing of the antipsychotic drug Zyprexa that could result in Lilly's paying more than $1 billion to federal and state governments.
If a deal is reached, the fine would be the largest ever paid by a drug company for breaking the U.S. laws that govern how drug makers can promote their medicines.
Several people involved in the investigation confirmed the settlement discussions. They insisted on anonymity because they have not been authorized to talk about the negotiations.
Zyprexa has serious side effects and is approved only to treat people with schizophrenia and severe bipolar disorder. But documents from Lilly show that between 2000 and 2003, Lilly encouraged doctors to prescribe Zyprexa to people with age-related dementia, as well as people with mild bipolar disorder who had previously been diagnosed only as depressed.
Although doctors can prescribe drugs for any use once they are on the market, it is illegal for drug makers to promote their medicines any uses not formally approved by the Food and Drug Administration.
Lilly may also plead guilty to a misdemeanor criminal charge as part of the agreement, the people involved with the investigation said. But the company would be allowed to keep selling Zyprexa to Medicare and Medicaid, the government health insurance programs that are the biggest customers for the drug. Zyprexa is Lilly's most profitable product and among the world's best-selling medicines, with 2007 sales of $4.8 billion, about half in the United States.
Lilly would neither confirm nor deny the settlement talks.
"We have been and are continuing to cooperate in state and federal investigations related to Zyprexa, including providing a broad range of documents and information," Lilly said in a statement Wednesday. "As part of that cooperation we regularly have discussions with the government. However, we have no intention of sharing those discussions with the news media and it would be speculative and irresponsible for anyone to do so."
Lilly also said that it had always followed state and federal laws when promoting Zyprexa.
The Lilly fine would be distributed among federal and state governments, which spend about $1.5 billion on Zyprexa each year through Medicare and Medicaid.
The fine would be in addition to $1.2 billion that Lilly has already paid to settle 30,000 lawsuits from people who claim that Zyprexa caused them to suffer diabetes or other diseases. Zyprexa can cause severe weight gain in many patients and has been linked to diabetes by the American Diabetes Association.
Prescriptions for Zyprexa have skidded since 2003 over concerns about those side effects. But the drug continues to be widely used, especially among severely mentally ill patients. Many psychiatrists say that it works better than other medicines at calming patients who are psychotic and hallucinating. About four million Zyprexa prescriptions were written in the United States last year.
U.S. prosecutors in Philadelphia are leading the settlement talks for the government, in consultation with the Department of Justice headquarters in Washington. State attorneys general's offices are also involved. Lawyers at Pepper Hamilton, a firm based in Philadelphia, and Sidley Austin, a firm based in Chicago, are negotiating for Lilly.
Nina Gussack, who is representing Lilly at Pepper Hamilton, said she could not comment on the case. Joseph Trautwein, an assistant United States attorney in the Eastern District of Pennsylvania, also declined to comment.
While a settlement has not been concluded and the negotiations could collapse, both sides want to reach an agreement, according to the people involved in the investigation. Besides the escalating pressure of the U.S. criminal inquiry, Lilly faces a civil trial scheduled for March in Anchorage, Alaska, in a lawsuit brought by Alaska to recover money the state has spent on Zyprexa prescriptions. A loss in that lawsuit would damage Lilly's bargaining position in the Philadelphia talks.
While expensive for Lilly, the settlement would end a four-year federal investigation and remove a cloud over Zyprexa. While Zyprexa prescriptions are falling, its overall dollar volume of sales is rising because Lilly has raised Zyprexa's price about 40 percent since 2003.
U.S. prosecutors have been investigating Lilly for its marketing of Zyprexa since 2004, and state attorneys general have investigate the case since 2005. The people involved in the investigations said the inquiries gained momentum after December 2006, when The New York Times published articles describing Lilly's multiyear efforts to play down Zyprexa's side effects and to promote the drug for conditions other than schizophrenia and severe bipolar disorder — a practice called off-label marketing.
Internal Lilly marketing documents and e-mail messages showed that Lilly wanted to convince doctors to prescribe Zyprexa for patients with age-related dementia or relatively mild bipolar disorder.
In one document, an unidentified Lilly marketing executive wrote that primary care doctors "do treat dementia" but leave schizophrenia and bipolar disorder to psychiatrists. As a result, "dementia should be first message" to primary-care doctors, according to the document, which appears to be part of a larger marketing presentation but is not marked more specifically. Later, the same document says that some primary care doctors "might prescribe outside of label."
In late 2000, Lilly began a marketing campaign called Viva Zyprexa and told its sales representatives to suggest that doctors prescribe Zyprexa to older patients with symptoms of dementia.
The documents were under U.S. court seal when The New York Times published the articles, and Judge Jack Weinstein of U.S. District Court in New York rebuked The Times for publishing them.
The settlement negotiations in Philadelphia began several months ago, according to the people involved in the investigation.
Last fall, the two sides were close to a deal in which Lilly would have paid less than $1 billion to settle the case, which at the time consisted only of a civil complaint.
Then Justice Department lawyers in Washington pressed for a grand jury investigation to examine whether Lilly should be charged criminally for its promotional activities, according to the people involved in the negotiations. A few days ago, facing the possibility of both civil and criminal charges, Lilly opened new discussions with the prosecutors in Philadelphia.
(1) Chantix is the drug that theoretically helps you quit smoking. It's the one with the commercials that tell you not to quit cold turkey, because you won't be able to do it. Instead, Pfizer wants you to get your insurance company to cover the cost of a "medication" that will supposedly help you to quit smoking, so instead of you paying for cigarettes, the other participants in your health insurance plan will pay for your new drug. Sounds fair to me! (No, wait, it doesn't.)
(2) NO ONE STUDIED THE EFFECTS OF MIXING CHANTIX AND ALCOHOL. Because I don't know anyone who both drinks and smokes. No, wait, I do. Practically everyone I know who smokes, also drinks. The only smokers I know who don't drink are homeless guys (from my volunteer work) who are trying to quit drinking. Sweet merciful God, who is running the FDA?
If you're reading this blog for the first time, please also check out these two posts:
The Food and Drug Administration announced an official safety review of the popular stop-smoking drug Chantix, which is the same drug many said may have contributed to a Dallas musician's violent outburst preceding his death.
Even before the violent rampage that led to the end of the Carter Albrecht's life, friends said he had been behaving strangely and placed the blame on the combination of alcohol and Pfizer-made Chantix.
Albrecht started to take Chantix a week before his death in an attempt to stop smoking.
Alcohol and Chantix have yet to be clinically studied together.
"Some people probably don't need to be taking it," said Ryann Rathbone, Albrecht's girlfriend.
After a News 8 report on Albrecht, countless of emails poured in from viewers and bloggers wrote about similar reports of depression and suicide related to Chantix.
A preliminary assessment of Chantix by the Food and Drug Administration stated that "many of the cases reflect new-onset of depressed mood, suicidal ideation and changes in emotion within days to weeks" of starting the Chantix treatment. Federal officials have launched a safety probe.
"Every safety review concerns me," said Mark Millard, a pulmonologist at Baylor University Medical Center.
Millard says he is concerned for another reason as well since he said the drug has helped many of his patients kick their smoking habit.
Despite the investigation, he said people shouldn't quit taking the drug unless they are having problems.
"If you feel different, if you feel your mood is depressed, if you feel despairing, if something is not right in the world, call your healthcare provider tomorrow morning and say, 'Do I need to keep taking this medication?'" he said.
I read this one in the print edition of Investors Business Daily (01/28/07). Here it is in a nutshell: 16 people have died from Botox (sold by Allergan) and Myobloc (sold by Solstice Neurosciences). They DIED while getting WRINKLES removed. Let me think how that could have happened... Oh, wait, isn't Botox BOTULISM? Yes, it is. It's BOtulinum TOXin. I'm pretty sure Saddam Hussein used this stuff to kill people back in Iraq.
You may ask yourself what the difference is between Big Pharma and Big Tobacco. It's something like this: Big Pharma doesn't have to carry Surgeon General's warnings, and gets to keep all the money from the sale of its products. Big Tobacco is practically banned (rather than shoved down your throat by the government), and is taxed to the high heavens (with all that tax money going to the government). Both products will kill you, but at least Big Tobacco has been forced to admit it.
So basically, no government agency checks to see whether thimerosal is actually gone from vaccines. They just take Big Pharma's word for it. The same Big Pharma that has lied about Vytorin, Vioxx, Lyrica, Sarafem, etc.
Last month I emailed the CDC to ask this question:
From: Twyla Ramos Sent: Wednesday, November 07, 2007 1:19 AM To: CDC Public Inquiry Subject: mercury in vaccines
I understand that thimerosal is no longer used as a preservative in most vaccines, except for most flu shots and vaccines shipped to other countries.
But, I believe I heard someone say that mercury is still used in the vaccine manufacturing process, but it is removed and only "trace" amounts remain in the finished vaccines.
Can you confirm whether or not there is any mercury used in the manufacture of thimerosal-free vaccines? If the above statement is true, how much is a "trace"?
Sincerely,
Twyla Ramos concerned parent
I received the following response:
From: "CDC-INFO" <CDCINFO@cdc.gov> To: Twyla Ramos Sent: Wednesday, November 07, 2007 2:57 PM Subject: RE: YBFW: Mercury in vaccines
Thank you for your inquiry to CDC-INFO. In response to your request for information on trace amount of thimerosal in some vaccines in the United States, we are pleased to provide you with the following relevant information.
Thimerosal is an organic mercury compound. It works very well as a preservative. It has been used in some vaccines and other products since the 1930s.
Thimerosal is made up of about 49 percent ethylmercury. The other 51 percent is a chemical that contains sulfur.
There is no evidence that the low doses of thimerosal in vaccines can cause any serious harm. However, it may cause minor allergic reactions, such as redness and swelling where the shot was given.
In July 1999, the Public Health Service (PHS) agencies, the American Academy of Pediatrics (AAP), and vaccine manufacturers agreed that thimerosal should be reduced or removed from vaccines. They did this to be extra careful, not because there was proof that thimerosal is harmful.
Until 1999, several vaccines given to infants in the United States contained thimerosal. These included vaccines against: * diphtheria, * tetanus, * pertussis (whooping cough), * Haemophilus influenzae type b (Hib), and * hepatitis B.
Today, some influenza (flu) vaccines and the Td (tetanus and diphtheria) vaccine still contain thimerosal. However, thimerosal-free flu vaccine is available for both children and adults.
None of the other vaccines used today in the United States to protect infants and toddlers against infectious diseases contain thimerosal as a preservative. Thimerosal still may be used in the early stages of making certain vaccines. However, it is removed through a purification process. When this process is complete, only trace, or insignificant, amounts of thimerosal are left (less than 0.3 mcg) and these amounts have no biological effect.
Links provided to non-Federal organizations are provided solely as a service to our users. These links do not constitute an endorsement of these organizations or their programs by CDC or the Federal Government, and none should be inferred. CDC is not responsible for the content of the individual organization web pages found at these links.
Thank you for contacting CDC-INFO Contact Center. Please do not hesitate to call 1-800-CDC-INFO, e-mail cdcinfo@cdc.gov or visit http://www.cdc.gov if you have any additional questions.
I emailed them a follow-up question:
From: Twyla Ramos Sent: 11/9/2007 09:24:08 AM To: <cdcinfo@cdc.gov> Subject: Re: YBFW: Mercury in vaccines
Thank you for this info. I have a follow-up question. You said, "Thimerosal still may be used in the early stages of making certain vaccines. However, it is removed through a purification process." Does any government agency monitor and test to ensure that this purification process is effective, and that the final product contains only "less than 0.3 mcg"? Or do the pharmaceutical companies have sole responsibility for the testing and monitoring of this?
The CDC responded:
From: "CDC-INFO" <CDCINFO@cdc.gov> To: Twyla Ramos Sent: Monday, November 12, 2007 11:42 AM Subject: RE: Re: YBFW: Mercury in vaccines
Thank you for your inquiry to CDC-INFO. In response to your follow-up request of information regarding monitoring the effectivity of the purification process of thimerosal in vaccines, please call the US Food and Drug Administration (FDA) at 1-888-INFO-FDA. FDA is the federal agency that regulates vaccine licensure and manufacture.
Thank you for contacting CDC-INFO Contact Center. Please do not hesitate to call 1-800-CDC-INFO, e-mail cdcinfo@cdc.gov or visit http://www.cdc.gov if you have any additional questions.
I contacted the FDA and received this response:
From: Hill, Lanessa To: Twyla Ramos Sent: Wednesday, November 14, 2007 6:14 AM Subject: RE: "Trace" amounts of Thimerosal in vaccines
Good morning Mrs. Ramos.
Thank you for your inquiry to FDA's Center for Biologics Evaluation and Research (CBER) regarding regulatory oversight of vaccines. CBER, one of six centers within FDA, is responsible for the regulation of biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products.
Because of the complex manufacturing process for most biological products, each lot undergoes thorough testing by the manufacturer. The manufacturer performs specific tests as specified in their license application. The manufacturer submits samples of each licensed vaccine lot and the results of their own tests for potency, safety, and sterility to the Agency. The manufacturer may not distribute a lot of the product into interstate commerce until CBER releases it. CBER will also test the samples provided by the manufacturers for potency, safety and purity. All vaccines are subject to lot release. The lot release program is part of FDA's multi-part strategy that helps assure biological product safety by providing a quality control check on product specifications.
The FDA continues to oversee the production of vaccines after the vaccine and the manufacturing processes are approved, in order to ensure continuing safety. After licensure, monitoring of the product and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the product.
I hope this is helpful. Best regards. Lanessa Hill Public Affairs Specialist Consumer Affairs Branch Division of Communication and Consumer Affairs Center for Biologics Evaluation and Research This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
I replied: From: Twyla Ramos To: Hill, Lanessa Sent: Wednesday, November 14, 2007 7:40 AM Subject: Re: "Trace" amounts of Thimerosal in vaccines
Thank you so much for this information. Do these tests for safety include tests of mercury content? My understanding is that removal of thimerosal is voluntary, so would this mean that testing for mercury content is not part of the agreed upon tests?
Specifically, in cases where thimerosal is used in the manufacturing process but is removed by a purification process, is mercury content part of the safety testing?
I received this response:
----- Original Message ----- From: Harley, Patricia To: Twyla Ramos Sent: Thursday, November 15, 2007 12:18 PM Subject: RE: "Trace" amounts of Thimerosal in vaccines Mrs. Ramos: Thank you for your inquiry to FDA's Center for Biologics Evaluation and Research (CBER) regarding thimerosal in vaccines. Your email has been forwarded to my office for reply. The Center for Biologics Evaluation and Research (CBER) regulates vaccine products. Many of these are childhood vaccines that have contributed to a significant reduction of vaccine-preventable diseases. Vaccines, as with all products regulated by FDA, undergo a rigorous review of laboratory and clinical data to ensure the safety, efficacy, purity and potency of these products. Vaccines approved for marketing may also be required to undergo additional studies to further evaluate the vaccine and often to address specific questions about the vaccine's safety, effectiveness, or possible side effects.
The FDA continues to oversee the production of vaccines after the vaccine and the manufacturing processes are approved, in order to ensure continuing safety. After licensure, monitoring of the product and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the product. If requested by the FDA, manufacturers are required to submit to the FDA the results of their own tests for potency, safety, and purity for each vaccine lot. They may also be required to submit samples of each vaccine lot to the FDA for testing. However, if the sponsor describes an alternative procedure which provides continued assurance of safety, purity and potency, CBER may determine that routine submission of lot release protocols (showing results of applicable tests) and samples is not necessary. Information on the Vaccine Product Approval Process is available on CBER's website at http://www.fda.gov/cber/vaccine/vacappr.htm. Information on Thimerosal in Vaccines is available on CBER's website at http://www.fda.gov/cber/vaccine/thimerosal.htm#toc.
If you have any additional questions, please feel free to call me. Sincerely, Patricia H. Harley Consumer Safety Officer Food and Drug Administration Center for Biologics Evaluation and Research Office of Communication, Training and Manufacturers Assistance Division of Communication and Consumer Affairs phone: 301-827-2000 or 1-800-835-4709 This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
I responded:
----- Original Message ----- From: Twyla Ramos To: Harley, Patricia Sent: Friday, November 16, 2007 8:13 AM Subject: Re: "Trace" amounts of Thimerosal in vaccines
Thank you for this information on your overall procedures. I still don't know the answer to my question: In cases where thimerosal is used in the manufacturing process but is removed by a purification process, is mercury content part of the safety testing?
Could you please tell me whether a testing process is in place to ensure that mercury has been successfully removed from vaccines, after thimerosal is used in the early stages of making those vaccines.
Thank you very much,
Twyla Ramos
I received the following response:
From: Harley, Patricia To: Twyla Ramos Sent: Monday, November 19, 2007 4:19 AM Subject: RE: "Trace" amounts of Thimerosal in vaccines
Twyla Ramos: You can contact the manufacturer for processing procedures. If you have additional questions, please feel free to call me.
Sincerely, Patricia H. Harley Consumer Safety Officer Food and Drug Administration Center for Biologics Evaluation and Research Office of Communication, Training and Manufacturers Assistance Division of Communication and Consumer Affairs phone: 301-827-2000 or 1-800-835-4709
I responded: From: Twyla Ramos To: Harley, Patricia Sent: Monday, November 19, 2007 8:19 AM Subject: Re: "Trace" amounts of Thimerosal in vaccines
My question is not for the manufacturers. My question is for the agencies that regulate the manufacturers. I started with the CDC, and they referred me to the FDA.
The CDC says: "Thimerosal still may be used in the early stages of making certain vaccines. However, it is removed through a purification process. When this process is complete, only trace, or insignificant, amounts of thimerosal are left (less than 0.3 mcg) and these amounts have no biological effect."
Are you saying that the FDA does not play a role in ensuring that the final product is either mercury-free or contains only a "trace" amount of mercury? Is this left up to the manufacturers?
I understand (as you stated in your email) that the FDA has procedures in place to "ensure the safety, efficacy, purity and potency of these products" and that "manufacturers are required to submit to the FDA the results of their own tests for potency, safety, and purity for each vaccine lot. They may also required to submit samples of each vaccine lot to the FDA for testing." Or an "alternative procedure" may be agreed upon. What I am asking is whether testing of mercury content is a part of this process.
Manufacturers are saying that they have a process in place to purify out the mercury. Is the FDA verifying in any way that this is true?
I did try calling you Friday, but you were out of the office.
Ms. Harley responded: From: Harley, Patricia To: Twyla Ramos Sent: Monday, November 19, 2007 8:35 AM Subject: RE: "Trace" amounts of Thimerosal in vaccines
Please call me.
Sincerely, Patricia H. Harley Consumer Safety Officer Food and Drug Administration Center for Biologics Evaluation and Research Office of Communication, Training and Manufacturers Assistance Division of Communication and Consumer Affairs phone: 301-827-2000
So, I tried calling Ms. Harley again, and this time I reached her. She continued to make general statements about validating the manufacturing process. She said the following:
• She does not know whether a company does a specific test.
• They cannot check every single vaccine. (Like, duh.)
• There is a lot release requirement. The company submits testing procedures and samples. The FDA verifies that the product is safe, pure, potent, functioning.
• She can't guarantee that there is a test for mercury.
• She is not sure whether the FDA is measuring the mercury content. They check the process. "We have the understanding that this has been done, that the manufacturer has done it. I doubt if any company would be trying to get away with that. The consequences are major for any violations. If the product does not conform to specifications it would be unlicensed product."
I really tried to get her to be more specific. I gave the example of, if you gave a person a recipe to bake a cake, and you wanted to see if it came out well, wouldn't you taste the cake, and look at it to see if it is mushy or burned? "The proof is in the pudding." It's not enough for the person just to verify that they bought the right ingredients and measured them and set the oven at 350 degrees.
She suggested that I check with state agencies.
So, in summary, neither the CDC nor the FDA could or would say that they are testing to be sure that the process of removing mercury from vaccines is working.
Why should they test for mercury? They don't believe that thimerosal is harmful. It is admittedly still being used in the vaccine manufacturing process, but then supposedly is being purified out. If the purification process is not actually working, why should the CDC and the FDA care? They don't believe thimerosal is harmful.
Yet, we know that even miniscule quantities of mercury are in fact harmful.
My question is: Is anyone out there testing today's vaccines for mercury? Are the vaccines that are supposedly mercury-free really mercury-free? How much mercury is actually in the vaccines which supposedly contain only a "trace" amount?
Do we trust the pharmaceutical companies to self-monitor on the issue of mercury content?
Supposedly mercury has been removed from vaccines, yet the autism rate is still high. Possible explanations for this are:
• Babies still receive an incredibly high number of vaccines, which include other potentially toxic and/or immune-system-disrupting ingredients such as aluminum and multiple live viruses.
• There are many environmental pollutants, such as mercury from coal burning power plants, which are possible causes.
But perhaps we are overlooking another possible explanation: Has mercury really been removed from vaccines?
Twyla Ramos and her husband have three children. Their middle child, age 15, has both Autism and Williams Syndrome. Twyla has a B.A. in English and works in the banking industry. She serves on the board of the Foothill Autism Alliance, a nonprofit group providing support and information to the autism community.
This is perhaps the most shameful thing I've read this week. The AAP wrote to ABC TV and demanded that ABC not air an episode of "Eli Stone" in which a lawyer argues that vaccines caused a child's autism. You can see n the AAP website who gives the big money to the AAP (Sanofi-Aventis, MedImmune, McNeil, AstraZeneca, and Merck are all $25,000 donors). You can imagine how much pressure they put on the AAP to hush up this episode of a FICTIONAL TV SHOW. You can imagine the help they gave good old Renee in writing her letter full of lies. (Fluzone, the very popular 10-dose vial of flu vaccine--part of the CDC's 2008 schedule of vaccines and mandatory in 2007 in states like New Jersey--still contains thimerosal. There are countless studies that link mercury--and thimerosal specifically--to autism; just read my previous blog posts.)
I urge pediatricians to write to the AAP and demand that scare tactics like these stop, immediately.
Quote
Support AAP Click the link and check out how many of the major donors are BIG PHARMA.
Then read this page:
By J.B. Handley
American Academy of Pediatrics, we’ve had it with you. Generation Rescue, an international autism organization, is officially declaring war on you for inexplicable complacency, complicity, and bureaucratic arrogance.
Most parents and autism organizations are extremely frustrated with the Centers for Disease Control, or CDC. They have been the target of attack ads, parent protests, and an entire website chronicling their misdeeds. Yet, at least with the CDC, we all see the conflict clearly: their #1 job, their raison d’être, is to administer vaccines.
With the AAP, the crime against our kids is actually more insidious, and in many ways more morally reprehensible. You are the people who are supposed to have our kid’s backs. And you don’t, not remotely.
Pouring salt in a growing wound is an absurd letter the AAP has written to the ABC television network protesting an upcoming TV show which they will be releasing to the press tomorrow, a complete copy of which you can read down below.
The letter, which I encourage you to forward to as many people and reporters as possible, takes the wildly predictable path of trying to guilt ABC into pulling a fictional TV show that lends credibility to the autism-vaccine link. The AAP writes:
“ABC will bear responsibility for the needless suffering and potential deaths of children from parents' decisions not to immunize based on the content of the episode.”
The letter also has two glaring factual errors (also known as “lies”):
1. AAP writes:
“If ABC persists in airing the show, the AAP urges the network to include a disclaimer emphasizing: No mercury is used as a preservative in routinely offered childhood vaccines.”
As we all know, the flu shot is a mandated vaccine on the CDC's 2008 vaccine schedule and the majority (about 80%) of our flu shot supply contains mercury.
2. AAP writes:
“No scientific link exists between vaccines and autism.”
Conveniently, the AAP just ignores these published studies because they do not fit the goal of the AAP of protecting from liability its dues-paying constituency: pediatricians who administer vaccines.
In the last 20 years, the AAP has stood by as the CDC has expanded the vaccine schedule for our kids from 10 vaccines to 36 before the age of 5 years old, and in that time the rates of autism have grown 6,000%.
A couple of years ago, Generation Rescue rented a booth at the AAP’s national convention. We were overwhelmed by the number of dues-paying pediatricians who came to our booth, listened to our stories of recovered children, and quietly agreed with our position on vaccines and autism. It’s like an underground railroad of pediatricians exists within the AAP who are wary of the vaccine load on our children and seek to find quiet ways to try and protect as many children as they can within their own practice by spacing out shots, educating parents, and being vigilant with higher-risk children.
Meanwhile, the AAP has become the vaccine-maker’s best friend, spending their member’s dues to lobby states to PREVENT thimerosal bans and wasting their time with ridiculous letters like the one below to try and prevent a television network from airing a TV show.
AAP, the gloves are officially off. It’s time you got your fair share of parent protests, national attack ads, and perhaps an inflatable rat or two outside your Illinois headquarters.
If you’d like to let AAP know what a poor job they are doing protecting our kids, you can let them have it here:
Here’s a complete copy of the letter the AAP will be releasing to the press tomorrow. I encourage you to send this to any reporters you know and point out the clear factual errors in the letter:
January 25, 2008
Anne Sweeney President, Disney-ABC Television Group 47 W. 66th St. New York, NY 10023-6290 Dear Ms. Sweeney:
According to The New York Times, ABC plans to run an episode of "Eli Stone" in which the title character successfully argues in court that a vaccine caused a child's autism. The American Academy of Pediatrics (AAP), an organization of 60,000 pediatricians, is alarmed that this program could lead to a tragic decline in immunization rates. The AAP calls on ABC to cancel the episode.
Many people trust the health information presented on fictional television shows, which influences their decisions about health care. In the United Kingdom, erroneous reports linking the measles vaccine to autism prompted a decline in vaccination and the worst outbreak of measles in two decades, including the deaths of several children.
ABC will bear responsibility for the needless suffering and potential deaths of children from parents' decisions not to immunize based on the content of the episode. If ABC persists in airing the show, the AAP urges the network to include a disclaimer emphasizing: No mercury is used as a preservative in routinely offered childhood vaccines.
No scientific link exists between vaccines and autism. Vaccines are the single-most powerful, cost-effective public health intervention ever developed. A network as influential as ABC must consider its responsibility not to promulgate messages that undermine the years of efforts by the AAP and public health community to persuade parents to vaccinate and protect their children. The consequences of a decline in immunization rates could be devastating to the health of our nation's children.
My mother sent me this article. It's just another example of the ridiculous misdirection of research dollars to genetic research. Here's my reply to her (along with the original AP article). Maybe a Congressman will read this post and WAKE UP to the tremendous waste of money going on in the name of science.
(1) The particular genetic problem mentioned in this article is (by the scientists' own admission) connected to about 1% of all cases of autism. How much money went into identifying the genetic problem linked to this 1%?
(2) None of the autistic children in this study had parents who had this particular genetic problem, so this isn't something couples could avoid (like Tay-Sachs disease) by choosing not to get pregnant in the first place--they could only choose to test pre-natally and abort.
(3) Geraldine Dawson of Autism Speaks (which denies that any children are recovering, because it won't admit to any possible links to vaccines) implies that "figur[ing] out ... the biological pathways" (which could help scientists develop chemical treatments for autism) depends entirely on determining the genes involved in autism--this is ridiculous, since DAN! doctors today are working with autistic children to determine the biological basis of their particular flavor of autism, and actually healing them through biomedical interventions such as the gluten-free, casein-free diet, antifungal treatments, etc.
In fact, to assert that one needs to know the genetic basis for a particular ailment in order to treat it is illogical on its face. If that were true, we would not be able to cure 95% of all Hodgkin's Disease patients, or treat any of the other illnesses that we currently treat without knowing which genetic foulups are linked to them.
(4) One of the researchers says that "the disorder must be due to a combination of genetic variations since there were cases of people who
had the defect but didn't have autism." Funny he should say that--doesn't it make more sense to consider the possibility that the genetic problem causes autism only when combined with exposure to a particular environmental toxin?
I'm sick of all the $$$ going to fund genetic research, when the upshot will be (a) no help to poor families, who can't afford pre-natal blood tests and (b) only limited help to rich families, who will only be able to choose abortion (and they'll be choosing in the dark, because this particular genetic problem isn't 100% correlated with having autism. What a crock.
Not only that, but this does not help ANY families struggling with autism today. I guess 1 in 150 children don't matter to scientists or the US government.
Study: Rare Gene Change Linked to Autism By LINDA A. JOHNSON – 1 hour ago A rare genetic variation dramatically raises the risk of developing autism, a large study showed, opening new research targets for better understanding the disorder and for treating it. Research into the causes of autism has focused on genetic causes because so many families have multiple children with the disorder. Thus far, only about 10 percent of autism cases have a known genetic cause. Boston-area researchers estimate the gene glitch they've identified accounts for another 1 percent of cases. They found a segment of a chromosome which has genes linked to brain development and various developmental disorders was either missing or duplicated far more often in autistic people. The defect was inherited in some cases, but more often the result of a random genetic accident. The results from the Autism Consortium study, released online Wednesday by the New England Journal of Medicine, confirm those of smaller studies by U.S. and Canadian research groups in the past year. The consortium verified its findings by checking two other DNA databases. "They really did nail it," said Dr. Andrew Zimmerman, director of the Kennedy Krieger Institute's Center for Autism & Related Disorders in Baltimore, who was not involved in the research. He predicted children newly diagnosed with autism or other developmental disorders now will be tested for this defect on chromosome 16 and that studies of many more DNA samples may reveal other autism-related gene variations. Already, the findings are starting to be used to give some parents long-sought answers to burning questions: What caused autism in their child and how likely is it that any future children also would have autism, long known to run in families? "We've provided very compelling evidence that this particular small stretch of the genome provides an important clue to the biological roots of autism," said lead researcher Mark J. Daly, an assistant genetics professor at Harvard Medical School and an investigator for the consortium, which includes researchers from 14 Boston-area universities and medical centers. When the biological pathways involved are figured out, scientists can try to design drugs to target chemicals in the brain to treat autism, said Geraldine Dawson, chief science officer of the advocacy group Autism Speaks. "I think chromosome 16 is now going to be a hotbed for autism research," said Thomas Lehner, head of the genomic research branch at the National Institute of Mental Health. "It gives us a very important lead." Another study researcher, Dr. David Miller of Children's Hospital Boston, said the chromosome 16 variations increased the risk of autism a hundredfold. But he said the disorder must be due to a combination of genetic variations since there were cases of people who had the defect but didn't have autism. Autism, a complex, poorly understood disorder, is characterized by repetitive behaviors and poor social interaction and communication skills. Research has mainly centered on genetic causes, and on whether it could be caused by the mercury-based preservative once used in childhood vaccines, which has been repeatedly discounted. The number of children diagnosed with autism has risen in recent years to as many as one in 150 American children, but experts are unsure whether its prevalence really is increasing or the trend is due to a broader definition of autism. For their study, consortium researchers scanned all 46 chromosomes from DNA samples from 1,441 children with autism or related disorders. They also scanned DNA from most of their parents and 2,800 other people, none known to have autism. The researchers found a 25-gene segment of chromosome 16 was missing in five children with autism; none of their parents had the deletion. That shows that in some cases the genetic glitch is not inherited from the parents, but instead due to a random accident while an egg or sperm is being formed. Another seven autistic children had a chromosome 16 duplication, but all but one had parents with the same duplication. The researchers confirmed their findings by looking at DNA databases from Children's Hospital Boston and Iceland. The same defect was found in 1 percent of those with autism or related disorders. It was found in just seven of about 19,000 Iceland samples from people without the disorder.
This would be unbelievable if I weren't already familiar with the games Big Pharma plays with the definition of "disease." I look forward to the massive marketing campaign encouraging me to dope myself up to kill some chronic pain, rather than investigating the source of the pain or taking steps to improve my overall health.
Update: I still believe Big Pharma is playing games with the newly approved fibromyalgia drug, trying to convince all of us that we have chronic pain and need to take Lyrica. However, the more I read about myalgic encephalomyelitis (ME), also known as chronic fatigue syndrome (CFS), the more I believe that a lot of people are suffering from new and weird diseases (kind of like autism), possibly brought on by vaccinations. For example, the onset of ME seems to be triggered by a virus--how hard is it to imagine a vaccine triggering it, or a vaccine-induced virus lurking in the body (cf. shingles from the new chicken pox vaccine, or measles) triggering it? You don't know anyone whose grandmother had ME, do you? Didn't think so. Yet it's a real disease plaguing as many as 1 in 200 people today. (See the second article below.)
Fibromyalgia is a real disease. Or so says Pfizer in a new television advertising campaign for Lyrica, the first medicine approved to treat the pain condition, whose very existence is questioned by some doctors.
For patient advocacy groups and doctors who specialize in fibromyalgia, the Lyrica approval is a milestone. They say they hope Lyrica and two other drugs that may be approved this year will legitimize fibromyalgia, just as Prozac brought depression into the mainstream.
But other doctors -- including the one who wrote the 1990 paper that defined fibromyalgia but who has since changed his mind -- say that the disease does not exist and that Lyrica and the other drugs will be taken by millions of people who do not need them.
As diagnosed, fibromyalgia primarily affects middle-aged women and is characterized by chronic, widespread pain of unknown origin. Many of its sufferers are afflicted by other similarly nebulous conditions, like irritable bowel syndrome.
Because fibromyalgia patients typically do not respond to conventional painkillers like aspirin, drug makers are focusing on medicines like Lyrica that affect the brain and the perception of pain.
Advocacy groups and doctors who treat fibromyalgia estimate that 2 to 4 percent of adult Americans, as many as 10 million people, suffer from the disorder.
Those figures are sharply disputed by those doctors who do not consider fibromyalgia a medically recognizable illness and who say that diagnosing the condition actually worsens suffering by causing patients to obsess over aches that other people simply tolerate. Further, they warn that Lyrica's side effects, which include severe weight gain, dizziness and edema, are very real, even if fibromyalgia is not.
Despite the controversy, the American College of Rheumatology, the Food and Drug Administration and insurers recognize fibromyalgia as a diagnosable disease. And drug companies are aggressively pursuing fibromyalgia treatments, seeing the potential for a major new market.
Hoping to follow Pfizer's lead, two other big drug companies, Eli Lilly and Forest Laboratories, have asked the F.D.A. to let them market drugs for fibromyalgia. Approval for both is likely later this year, analysts say.
Worldwide sales of Lyrica, which is also used to treat diabetic nerve pain and seizures and which received F.D.A. approval in June for fibromyalgia, reached $1.8 billion in 2007, up 50 percent from 2006. Analysts predict sales will rise an additional 30 percent this year, helped by consumer advertising.
In November, Pfizer began a television ad campaign for Lyrica that features a middle-aged woman who appears to be reading from her diary. ''Today I struggled with my fibromyalgia; I had pain all over,'' she says, before turning to the camera and adding, ''Fibromyalgia is a real, widespread pain condition.''
Doctors who specialize in treating fibromyalgia say that the disorder is undertreated and that its sufferers have been stigmatized as chronic complainers. The new drugs will encourage doctors to treat fibromyalgia patients, said Dr. Dan Clauw, a professor of medicine at the University of Michigan who has consulted with Pfizer, Lilly and Forest.
''What's going to happen with fibromyalgia is going to be the exact thing that happened to depression with Prozac,'' Dr. Clauw said. ''These are legitimate problems that need treatments.''
Dr. Clauw said that brain scans of people who have fibromyalgia reveal differences in the way they process pain, although the doctors acknowledge that they cannot determine who will report having fibromyalgia by looking at a scan.
Lynne Matallana, president of the National Fibromyalgia Association, a patients' advocacy group that receives some of its financing from drug companies, said the new drugs would help people accept the existence of fibromyalgia. ''The day that the F.D.A. approved a drug and we had a public service announcement, my pain became real to people,'' Ms. Matallana said.
Ms. Matallana said she had suffered from fibromyalgia since 1993. At one point, the pain kept her bedridden for two years, she said. Today she still has pain, but a mix of drug and nondrug treatments -- as well as support from her family and her desire to run the National Fibromyalgia Association -- has enabled her to improve her health, she said. She declined to say whether she takes Lyrica.
''I just got to a point where I felt, I have pain but I'm going to have to figure out how to live with it,'' she said. ''I absolutely still have fibromyalgia.''
But doctors who are skeptical of fibromyalgia say vague complaints of chronic pain do not add up to a disease. No biological tests exist to diagnose fibromyalgia, and the condition cannot be linked to any environmental or biological causes.
The diagnosis of fibromyalgia itself worsens the condition by encouraging people to think of themselves as sick and catalog their pain, said Dr. Nortin Hadler, a rheumatologist and professor of medicine at the University of North Carolina who has written extensively about fibromyalgia.
''These people live under a cloud,'' he said. ''And the more they seem to be around the medical establishment, the sicker they get.''
Dr. Frederick Wolfe, the director of the National Databank for Rheumatic Diseases and the lead author of the 1990 paper that first defined the diagnostic guidelines for fibromyalgia, says he has become cynical and discouraged about the diagnosis. He now considers the condition a physical response to stress, depression, and economic and social anxiety.
''Some of us in those days thought that we had actually identified a disease, which this clearly is not,'' Dr. Wolfe said. ''To make people ill, to give them an illness, was the wrong thing.''
In general, fibromyalgia patients complain not just of chronic pain but of many other symptoms, Dr. Wolfe said. A survey of 2,500 fibromyalgia patients published in 2007 by the National Fibromyalgia Association indicated that 63 percent reported suffering from back pain, 40 percent from chronic fatigue syndrome, and 30 percent from ringing in the ears, among other conditions. Many also reported that fibromyalgia interfered with their daily lives, with activities like walking or climbing stairs.
Most people ''manage to get through life with some vicissitudes, but we adapt,'' said Dr. George Ehrlich, a rheumatologist and an adjunct professor at the University of Pennsylvania. ''People with fibromyalgia do not adapt.''
Both sides agree that people who are identified as having fibromyalgia do not get much relief from traditional pain medicines, whether anti-inflammatory drugs like ibuprofen -- sold as Advil, among other brands -- or prescription opiates like Vicodin. So drug companies have sought other ways to reduce pain.
Pfizer's Lyrica, known generically as pregabalin, binds to receptors in the brain and spinal cord and seems to reduce activity in the central nervous system.
Exactly why and how Lyrica reduces pain is unclear. In clinical trials, patients taking the drug reported that their pain -- whether from fibromyalgia, shingles or diabetic nerve damage -- fell on average about 2 points on a 10-point scale, compared with 1 point for patients taking a placebo. About 30 percent of patients said their pain fell by at least half, compared with 15 percent taking placebos.
The F.D.A. reviewers who initially examined Pfizer's application for Lyrica in 2004 for diabetic nerve pain found those results unimpressive, especially in comparison to Lyrica's side effects. The reviewers recommended against approving the drug, citing itsside effects.
In many patients, Lyrica causes weight gain and edema, or swelling, as well as dizziness and sleepiness. In 12-week trials, 9 percent of patients saw their weight rise more than 7 percent, and the weight gain appeared to continue over time. The potential for weight gain is a special concern because many fibromyalgia patients are already overweight: the average fibromyalgia patient in the 2007 survey reported weighing 180 pounds and standing 5 feet 4 inches.
But senior F.D.A. officials overruled the initial reviewers, noting that severe pain can be incapacitating. ''While pregabalin does present a number of concerns related to its potential for toxicity, the overall risk-to-benefit ratio supports the approval of this product,'' Dr. Bob Rappaport, the director of the F.D.A. division reviewing the drug, wrote in June 2004.
Pfizer began selling Lyrica in the United States in 2005. The next year the company asked for F.D.A. approval to market the drug as a fibromyalgia treatment. The F.D.A. granted that request in June 2007.
Pfizer has steadily ramped up consumer advertising of Lyrica. During the first nine months of 2007, it spent $46 million on ads, compared with $33 million in 2006, according to TNS Media Intelligence.
Dr. Steve Romano, a psychiatrist and a Pfizer vice president who oversees Lyrica, says the company expects that Lyrica will be prescribed for fibromyalgia both by specialists like neurologists and by primary care doctors. As doctors see that the drug helps control pain, they will be more willing to use it, he said.
''When you help physicians to recognize the condition and you give them treatments that are well tolerated, you overcome their reluctance,'' he said.
Both the Lilly and Forest drugs being proposed for fibromyalgia were originally developed as antidepressants, and both work by increasing levels of serotonin and norepinephrine, brain transmitters that affect mood. The Lilly drug, Cymbalta, is already available in the United States, while the Forest drug, milnacipran, is sold in many countries, though not the United States.
Dr. Amy Chappell, a medical fellow at Lilly, said that even though Cymbalta is an antidepressant, its effects on fibromyalgia pain are independent of its antidepressant effects. In clinical trials, she said, even fibromyalgia patients who are not depressed report relief from their pain on Cymbalta.
The overall efficacy of Cymbalta and milnacipran is similar to that of Lyrica. Analysts and the companies expect that the drugs will probably be used together.
''There's definitely room for several drugs,'' Dr. Chappell said.
But physicians who are opposed to the fibromyalgia diagnosis say the new drugs will probably do little for patients. Over time, fibromyalgia patients tend to cycle among many different painkillers, sleep medicines and antidepressants, using each for a while until its benefit fades, Dr. Wolfe said.
''The fundamental problem is that the improvement that you see, which is not really great in clinical trials, is not maintained,'' Dr. Wolfe said.
Still, Dr. Wolfe expects the drugs will be widely used. The companies, he said, are ''going to make a fortune.''
* * *
ME: 'Invisible disease' is now easier to read Last Updated: 12:01am GMT 18/03/2008 http://www.telegraph.co.uk/ A simple blood test may revolutionise the way we treat patients with ME, reports Bob Ward British researchers are close to developing, for the first time, a blood test and potential drug treatments for myalgic encephalomyelitis (ME), also known as chronic fatigue syndrome (CFS), following groundbreaking work on its genetic origins. ME/CFS affects about one in 200 people, and women sufferers outnumber men by six to one. It causes a constant feeling of extreme exhaustion and malaise for more than six months, along with sleep abnormalities, memory and concentration difficulties and a great deal of pain. In its most extreme form, the disease leaves sufferers bed-ridden and can even be fatal. But patients now have new hope, thanks to research published in the Journal of Clinical Pathology by Dr Jonathan Kerr of St George's University of London and his colleagues. They have identified 88 genes that produce different levels of proteins and other molecules in ME/CFS sufferers compared with the rest of the population. Dr Kerr's team carried out a complex analysis of the records of 55 patients and found that they could be divided into seven sub-types according to the specific gene combinations found in their white blood cells, and the severity of their symptoms. The most acutely affected patients had 71 of the 88 gene abnormalities. The results of this work should allow better understanding of the causes and development of the disease. Many of the genes are known to be affected when a person contracts a virus, a factor which is believed to trigger many cases of ME/CFS. Importantly, the researchers also recognised that five of the 88 genes are targeted by drugs which are already used to treat other diseases. The team is now investigating whether the faulty genes produce abnormal levels of proteins that can be detected as minute quantities of "biomarkers" in the blood of patients. "If proven to be sensitive and specific indicators of the illness, the discovery of protein biomarkers could lead to the development of a diagnostic test for ME/CFS, which would revolutionise our approach to this disease," explains Dr Kerr. He will present his results at a conference on ME/CFS biomedical research in Cambridge in May. The research may even lead to a change in attitudes to the disease, often trivialised as "yuppie flu". Sarah, 31, who was diagnosed with ME/CFS two years ago, says: "The stigma associated with the disease can sometimes be as much of a problem as the symptoms. "Some think that it is 'all in the mind' and can be cured by a good night's sleep. It can be difficult to get friends and work colleagues to understand just how difficult it is to live with a disease that is so debilitating but virtually invisible." Attitudes among funders of medical research also need to change, says Dr Neil Abbot, operations director at the charity ME Research UK. "Studies on the psychological aspects of ME/CFS seem to have vacuumed up attention and funding at the expense of hard-core biomedical studies," he says. "Most of the £3 million spent by the Medical Research Council on the illness in the last six years has gone towards projects on the psychological management of the disease, while there is evidence that around 30 applications, some from established biomedical research groups, have not been funded." The work carried out by Dr Kerr and his colleagues is funded by a small charity, the CFS Research Foundation, which was set up in 1993 by a group of doctors and scientists who were concerned about the direction and quality of work on the disease. Its director, Anne Faulkner, is optimistic about the search for a cure: "We believe that this disease can and will be conquered, but it will need the dedicated work of distinguished research scientists and the determination of people in the community to bring this about."
Cholesterol Drug's Ad Campaign Turns Into PR Nightmare, Fanning Flames of Public Mistrust of DTC
By Rich Thomaselli
Published: January 21, 2008
CHARLOTTE, N.C. (AdAge.com) -- The video shows the oh-so-familiar commercial for cholesterol drug Vytorin, in which benign-looking "aunts" and "uncles" are dressed up to look like platefuls of fatty foods. What's different, however, is the voice-over: "Nobody knows if Vytorin is safe or effective, but with enough scientific fraud, we can sure make it looks like it is," says the narrator in the YouTube parody.
Reports that Merck & Co. and Schering-Plough Corp. kept under wraps for more than a year findings that Vytorin does not deliver results it spent more than $100 million advertising to consumers is much more than a PR disaster for the drug's co-marketers. Coming on the heels of a New York Times story that Pfizer's $2 billion drug Lyrica treats a condition, fibromyalgia, that a lot of doctors don't think exists, the Vytorin news is fanning the flames of public mistrust for the $5 billion direct-to-consumer drug industry -- and the ad business in general.
"The pharmas are in big trouble in terms of credibility," said brand expert Rob Frankel, who runs his own consultancy at RobFrankel.com. "They're just above Congress and used-car salesmen."
Results may vary
The scientific study conducted among 720 patients with hereditary high cholesterol showed that Vytorin (a combination of two cholesterol drugs, Zetia and Zocor) did not reduce the build-up of fatty plaque in the arteries as promised in the companies' marketing.
The two-year study was completed in April 2006, but Merck and Schering didn't make it public until last week. The reasons they cited were complexity of the data and their own scientific concerns, which led them to do more research. In the interim, the drug was reaping billions in sales.
That's sparked U.S. Reps. John Dingell and Bart Stupak (both D-Mich.) to write a letter to the two drug companies and the Food and Drug Administration asking why "the massive advertisement campaign for Vytorin was allowed to continue" when "the study's results may have been available to Schering-Plough and Merck officials."
There's a lot at stake here beyond drawing more political heat to the drug business. Vytorin is one of the players in the lucrative $18 billion cholesterol-drug market that includes market leader Lipitor, from Pfizer, and AstraZeneca's Crestor. Vytorin notched $1.5 billion in sales through the first nine months of 2007 according to pharmaceutical research group IMS Health, and Zetia earned $1.3 billion in sales.
High recall rate
The drug makers spent $102 million to market Vytorin through the first nine months of last year, according TNS Media Intelligence, and $83 million on Zetia. The TV spots from DDB Worldwide for Vytorin are consistently among the most-recalled by viewers according to IAG Research.
Schering-Plough spokesman Lee Davies said the company is still evaluating the schedule of the advertising, but added that information on its future ad plans is proprietary.
Dr. Sidney Wolfe, director of the Health Research Group for Washington-based advocate Public Citizen, said he isn't surprised the ads continue to run. "There's a $20 billion market for cholesterol-lowering drugs, and companies will do whatever it takes to get as much of that market as they can, even if it means letting people continue to take prescription drugs that they know are not beneficial and that even may be harmful," he said. "What's much more likely is that the companies put their stockholders above their responsibility to public health."
Unlike Merck's Vioxx, which in 2004 was found to contribute to heart attacks in some patients and was pulled off the market, Vytorin is safe and can still be sold. It does, the study found, reduce the levels of LDL in patients. It just doesn't, according to the study, live up to its claim of reducing plaque build-up. That's why Peter Pitts, a former associate commissioner for the FDA and now the president of New York-based Center for Medicine in the Public Interest, says this won't be the death knell for DTC that some think it is.
Question of relevance
"Just because a congressman sneezes doesn't mean pharmaceutical companies will catch a cold," Mr. Pitts said. "DTC is heavily regulated and the question becomes 'What does the study tell us and how is it relevant to DTC?' It's a small study and a study based on certain genotypes. If you're currently on Vytorin, you don't have to stop taking it."
But even Mr. Pitts, a strong advocate for DTC, admits drug companies need an image boost. "The industry should absolutely explain to the general population where drugs come from and how they're made," he said. "It's going to be hard. It's going to be a long-term proposition. But it's important for the viability of its image with consumers, not to mention the people on Capitol Hill."
Then again, it may be too late. "Frankly, I don't think it would do any good," said Alan Siegel, chairman-CEO of strategic branding consultancy Siegel & Gale, New York. "Their advertising is ubiquitous and there's a lot of backlash from people who feel they're being force-fed drugs. Now you have this issue with Vytorin, you have high drug prices. ... I don't think more advertising is going to solve their problems. Until they do something substantive in terms of pricing and being responsible with the advertising they already do, a brand campaign for the industry isn't going to do anything."
Spotlight may move to OTC drugs
Drug marketers soon may have one more thing to worry about: Congress may tell the Food and Drug Administration to scrutinize ads for over-the-counter drugs.
Two legislative heavyweights, Sen. Ted Kennedy (D-Mass.) and Rep. Henry Waxman (D-Calif.) late last year proposed legislation that would expand the FDA's authority and its right to preview direct-to-consumer ads for drugs sold over the counter. They could try to pass the legislation this year.
While the FDA can quash unapproved ad claims for OTC drugs, the ads typically are reviewed by the Federal Trade Commission, which handles drug ads like any others, investigating complaints after ads run.
FDA supervision could force marketers to get prior approval before running ads and subject marketers to fines not only if the ads are untruthful but also if any potential side effects aren't displayed prominently enough.
People close to the situation say Mr. Kennedy, chairman of the Senate Committee on Health Education Labor and Pensions, and Mr. Waxman, chairman of the House Committee on Oversight and Government Reform, will hold hearings on the legislation this year, but in the shortened election-year session, it still isn't clear how far they will proceed beyond that.
Ad groups are worried. They have placed the issue as their No. 1 congressional concern for this year.
"When you get a Waxman or a Kennedy, you have to take it seriously," said Jeff Perlman, exec VP of the American Advertising Federation.
Dan Jaffe, exec VP of the Association of National Advertisers, said drugs are sold over the counter precisely because there isn't as much of a safety issue as for prescription products.
"The whole point of having two categories is not to treat apples and oranges the same," he said. "To treat over-the-counter drugs and prescription drugs as equally dangerous we think is misguided."
He said he is hopeful the bills won't get a vote but also cautious.
"The people who are pushing this have to be taken seriously," he said.
Dick O'Brien, exec VP of the American Association of Advertising Agencies, said there is concern that whatever happens this year in Congress, any steps forward could increase the likelihood the measure will pass if a Democratic administration takes office next year.
A group of genes with known links to natural-killer cells -- the first to attack viruses, bacteria and malignancies -- are expressed at high levels in the blood of children with autism when compared to children without the disorder, according to a new study from the UC Davis M.I.N.D. Institute. Researchers also found gene expression distinctions in children with early onset and regressive forms of the disorder. The outcomes, published in the January issue of Genomics, offer hope that gene expression analyses can provide biological evidence of autism, currently diagnosed only through behavioral assessments, in some children. "What we found were 11 specific genes with expression levels that were significantly higher in the blood of children with autism when compared to the blood of typically developing children," said Frank Sharp, senior author of the study and professor of neurology with the M.I.N.D. Institute. "Those 11 genes are all known to be expressed by natural-killer cells, which are cells in the immune system necessary for mounting a defense against infected cells. We were surprised by our results because we were not looking for these particular genes. And while a number of studies have shown immune system dysregulation to be an important factor in autism, ours is one of the first to implicate these particular cells." In conducting the study, Sharp, molecular pathologist Jeff Gregg and their M.I.N.D. Institute colleagues used blood samples from 35 children diagnosed with autism, 14 with development delay but not autism and 12 typically developing children. The samples were subjected to gene expression analysis using microarrays and compared for common patterns. In addition to finding the 11 genes with natural-killer cell connections shared by all of the children with autism, they identified a pattern of 140 genes differentially expressed in children with the early onset form of the disorder and a pattern of 20 genes differentially expressed in children with the regressive form of the disorder. The team is the first to use genomic profiling of blood to observe differences in children with autism. A serious and increasingly prevalent neurodevelopmental disorder, autism is characterized by language impairments, social deficits and limited, repetitive behaviors. While some parents report they knew something was wrong with their child close to birth, others report their children progressed just like others and then lost social and/or language skills later, usually between the ages of 1 and 2. These separate experiences led clinicians to hypothesize that there are at least two types of autism -- early onset and regressive. This study offers biological evidence of those two subtypes. Microarrays are used to examine the expression levels of thousands of genes simultaneously. Because of its accuracy, the technology may become an important diagnostic tool for a variety of neurological conditions, including ischemic stroke and multiple sclerosis. To perform the analysis, RNA is isolated from cells in the blood. Complimentary strands of DNA (cDNA) are then created using the RNA as a template. Fluorescently labeled cRNA is next made from the cDNA and hybridized with the DNA on the array. Scanners using laser technology then read the array, revealing which genes are expressed and at what levels. In addition to being expressed by natural-killer cells, some of the 11 genes found to be expressed at higher levels in children with autism are also expressed by CD8+ T lymphocytes -- cells that target infected cells and, once bound to them, destroy them. It is not yet clear whether autism involves a primary problem in natural-killer cells, CD8+ lymphocytes or both. "What we are seeing can reflect something in the environment that is triggering the activation of these genes or something genetic that the children have from the time they were conceived," Sharp explained. "Such an immune response could be caused by exposure to a virus, another infectious agent or even a toxin. Another possibility is that these changes represent a genetic susceptibility factor that predisposes children to autism when they are exposed to some environmental factor." He added that the current study also does not identify whether or not the natural- killer cells are functioning abnormally, which further work by M.I.N.D. Institute immunologists will reveal. "If the natural-killer cells are dysfunctional, this might mean that they cannot rid a pregnant mother, fetus or newborn of an infection, which could contribute to autism." Gregg and Sharp consider the findings preliminary until they can be replicated, but still believe the study results point them in a new research direction that will shed light on the biological foundations of autism and eventually lead to new therapeutic targets. The study, "Gene Expression Profiles in Children with Autism," was funded by the National Institutes of Environmental Health Sciences and the U.S. Environmental Protection Agency through the UC Davis Center for Children's Environmental Health and the UC Davis M.I.N.D. Institute. A copy can be downloaded at www.sciencedirect.com.
Can anyone just have the guts to say it out loud: China is a horrible country, with horrible human rights abuses and horrible abuses of the planet, with repercussions we've only begun to feel? I know they own a lot of our (US) debt, but come on! If I were an Olympic athlete, I'd say, "Screw the medal" and save my health, even if the whole Tiananmen Square thing (which everyone seems to have forgotten) didn't bother me.
U.S. Olympians Devise Solution to Smog: Mask By JULIET MACUR COLORADO SPRINGS — As the lead exercise physiologist for the United States Olympic Committee, Randy Wilber has been fielding one bizarre question after another from American athletes training for the Beijing Games.
Should I run behind a bus and breathe in the exhaust? Should I train on the highway during rush hour? Is there any way to acclimate myself to pollution?
Mr. Wilber answers those questions with a steadfast, "No."
"We have to be extremely careful and steer them in the right direction because the mind-set of the elite athlete is to do anything it takes to get that advantage," he said. "If they thought locking themselves in the garage with the car running would help them win a gold medal, I'm sure they would do it. Our job, obviously, is to prevent that."
Mr. Wilber, a 53-year-old scientist based here at the United States Olympic Training Center, has spent most of the past two years vying with his counterparts from other nations to devise smarter, safer ways for athletes to face Beijing's noxious air.
To protect the athletes, Mr. Wilber is encouraging them to train elsewhere and arrive in Beijing at the last possible moment. He is also testing possible Olympians to see if they qualify for an International Olympic Committee exemption to use an asthma inhaler. And, in what may be a controversial recommendation, Mr. Wilber is urging all the athletes to wear specially designed masks over their noses and mouths from the minute they step foot in Beijing until they begin competing.
His multipronged strategy could give the United States team an advantage over teams from less-prepared countries. But the plan has a downside: it runs the risk of offending the host country, creating political tension.
Chinese officials say the air in Beijing, one of the most polluted cities in the world, will not be an issue when China's first Olympic Games start Aug. 8. They plan to limit vehicle use, close factories and do everything in their power to bring blue skies to Beijing. Jacques Rogge, the I.O.C. president, said he was confident the air would be clean because Chinese officials "are not going to let down the world."
Mr. Rogge and Peter Ueberroth, the U.S.O.C. chairman, recalled that pollution was a concern before the Summer Games in 1984 in Los Angeles and in 2004 in Athens, but that the air quality was not a problem when competition began.
But with the Olympics less than seven months away, scientists are skeptical about the air quality for these Summer Games. Olympic teams around the world are preparing for the worst.
Pollution levels on a typical day in Beijing, some researchers say, are nearly five times above World Health Organization standards for safety. The marathon world-record holder Haile Gebrselassie, who has allergies, and the world's No. 1 women's tennis player, Justine Henin, who has asthma, have expressed reservations about competing in the Olympics for fear that pollution will exacerbate their breathing problems.
Some athletes who competed in Olympic test events last year complained that the foul air made it difficult to breathe and caused upper-respiratory infections and nausea. Colby Pearce, 35, an Olympic hopeful in track cycling from Boulder, Colo., said he saw smog floating inside the velodrome in Beijing. His throat became scratchy and he developed bronchitis, he said, because of air pollution.
"When you are coughing up black mucus, you have to stop for a second and say: 'O.K., I get it. This is a really, really bad problem we're looking at,' " he said.
The United States boxing team, while competing in China last month, ran in the hotel hallways instead of on the streets because the air was "disgusting," said Joe Smith, the team manager.
To combat the problem of air quality, Mr. Wilber and his counterparts from countries with sufficient money have been in silent, clandestine competition, each trying to devise a better plan.
Jon Kolb, an environmental physiologist with the Canadian Olympic Committee, bristled when asked about Canada's plan, saying, "We would prefer to keep our strategies to ourselves." He did say, however, that Canadian athletes would not wear masks.
If Beijing is still badly polluted in August, the athletes most affected will be marathoners, triathletes and cyclists — endurance athletes who will compete outdoors for hours.
Mr. Rogge has announced a backup plan for those sports. If the pollution level on competition days poses a danger to athletes, those events will be rescheduled.
The Body's Reaction
The body's reaction to pollution exposure is immediate, said George Thurston, a professor of environmental medicine at N.Y.U. School of Medicine.
"Your body says, 'This air is bad; breathe less of it,' and that's a defensive mechanism," Mr. Thurston said. "For athletes, that means they will go into oxygen debt sooner and will start cramping up. At an event like the Olympics, that could be disastrous."
Pollution can also provoke allergic reactions, Mr. Thurston said, or set off an asthma attack. The risk of a heart attack rises on high-pollution days, he said.
He worries most about ozone and particulate matter, two of five major pollutants — carbon monoxide, sulfur dioxide and nitrogen dioxide are the others — that could affect an athlete's performance. Vehicle emissions, coal-fueled factories and construction sites in and around Beijing generate the high level of air pollution.
"Ozone directly affects the lungs, and at high-enough levels, it would cause fluid to come into the lungs," Mr. Thurston said. "Particulate matter is actually breathed in, and the particles deposit on the lungs and can actually pass through the lungs and into the bloodstream. Both can cause acute reactions in people exposed to them."
Recently, Mr. Wilber has become an expert on those pollutants. Since coming to the U.S.O.C. 15 years ago as a doctoral candidate at Florida State University, Mr. Wilber has helped athletes adapt to different environments: high altitudes, extreme cold, time-zone changes and, in the case of Beijing, high heat and humidity. In March 2006, his focus turned to the pollution in China.
Since then, he has traveled to Beijing three times to measure the pollution at each Olympic site. Along the way, he has bumped into some of his colleagues, all stealthily measuring the same air. He said none of them wanted to rely on the statistics provided by Chinese officials.
Mr. Wilber said his numbers were disturbingly high, with levels of certain pollutants "significantly higher" than they were at the 2004 Athens Games and at the 1984 Los Angeles Games. So Mr. Wilber scouted for possible alternate training sites in South Korea, Singapore, Japan and Malaysia for use in the days before the Beijing Games. The triathlon team will train in South Korea, and the canoe and kayak athletes will go to Japan.
"We've got to take a lot of precautions to keep our athletes away from the Olympic hoopla and out of the pollution before their event," said Chris Hipgrave, the Olympic high performance director at USA Canoe/Kayak.
Inhalers May Be Popular
The canoe/kayak athletes participated in Mr. Wilber's testing for exercise-induced asthma to see who may need an inhaler at the Olympics. The inhalers, which would help breathing by opening the airways, contain beta-2 agonists, a category of drug banned by the World Anti-Doping Agency. The I.O.C. would then review the documentation of the athletes who hope to use the inhalers. Mr. Wilber said that one-fourth of United States Olympic athletes since 1994 had tested positive for exercise-induced asthma.
"It's pretty rare to have a full-blown asthma attack because of pollution, but it will affect an athlete's performance, and our testing shows that," Mr. Wilber said. "You're not going to drop dead, but your oxygen transport is definitely being compromised. It could mean the difference between a gold medal and finishing in the back of the pack."
Tim Hornsby, an Olympic hopeful in sprint kayak who has exercise-induced asthma, said having an inhaler would be crucial for those with breathing problems. "It's frightening to feel like you can't breathe," he said.
Mr. Wilber's U.S.O.C. laboratory here helped design a mask featuring an activated carbon filtration system. He is secretive about the details, hesitant to show it or to have it photographed.
Roughly 750 to 1,000 masks, which cost about $20 to $25 each, will be part of the Olympic gear given to athletes. The masks filter 85 percent to 100 percent of the main pollutants, Mr. Wilber said, compared with paper masks, which filter 25 percent to 45 percent.
At the 2006 world junior track and field championships in Beijing, Mr. Wilber tested an early version of the mask, but it impeded breathing. After redesigns that Mr. Wilber would not describe, the new mask can be worn during training and competition.
The I.O.C. spokeswoman Sandrine Tonge said the international federation for each sport made the rules on what athletes can and can't wear in competition. So it is conceivable that some athletes will wear masks during their Olympic events, but Mr. Wilber said no Americans would do so.
"I think it would be a huge political issue and an embarrassment to the Chinese people and to the I.O.C. if American athletes wore masks in the event itself," Mr. Wilber said. "If that image was beamed around the world on TV, it would cause nothing but problems."
He added, "It's much more important to guard against the pollution beforehand and go to the line with clean lungs."
In an effort to do that, United States triathletes wore masks in China last September, but removed them before competing. They stepped off the bus looking like a group of incredibly fit surgeons or, as one triathlete put it, a gathering of Darth Vaders.
No other teams were wearing masks. Some opponents snickered.
"You do look kind of silly wearing it," said Jarrod Shoemaker, 25, of Sudbury, Mass., who had competed in Beijing twice before. "But I wore it before the race this time, and I didn't feel burning in my throat afterward. I could still taste the grit on my teeth, but I could actually talk and breathe. That wasn't the case in other years.
"For now, it looks like we're the ones with a huge advantage. We want to keep it that way."
I think this is both tragic and hilarious. First, tragic that we've f***ed up the oceans so badly that we can't eat tuna anymore. I mean, it's now to the point where it's hazardous to adults (not just pregnant women and small children). Second, it's funny that Sushi of Gari is one of the places named in this article, because my apartment is next door to the place, and up until about two months ago, they stored their food prep bowls and salad oils next to open garbage cans in the alley between our buildings. (Now, the bowls and oils are locked in a couple of cabinets ... next to the open garbage cans.) Anyway, if you weren't convinced by the mercury, you should be convinced by the garbage: Sushi of Gari is unsafe at any speed.
Tests find hazardous levels of mercury in tuna sushi in New York
By Marian Burros
Tuesday, January 22, 2008
NEW YORK: Recent laboratory tests performed for The New York Times found so much mercury in tuna sushi that a regular diet of even two or three pieces a week at some restaurants could be a health hazard for the average adult, based on guidelines set out by the Environmental Protection Agency.
Eight of the 44 pieces of sushi The Times purchased from local restaurants and stores in October had mercury levels so high that the Food and Drug Administration could take legal action to remove the fish from the market.
Although all the samples were gathered in New York City, experts believe similar results would be observed elsewhere. "Mercury levels in bluefin are likely to be very high, regardless of location," said Tim Fitzgerald, a marine scientist for Environmental Defense, an advocacy group that works to protect the environment and improve human health. Most of the stores and restaurants in the survey said the tuna The Times had sampled was bluefin.
In 2004, the Food and Drug Administration joined with the Environmental Protection Agency to warn children and women who may become pregnant to limit their consumption of certain varieties of canned tuna because the mercury it contained might damage the developing nervous system. Fresh tuna was not included in the advisory. The tuna sushi in The Times sample contained far more mercury than is typically found in canned tuna.
Over the past several years, studies have suggested that mercury may also cause health problems for adults, including an increased risk of cardiovascular disease and neurological symptoms.
Dr. P. Michael Bolger, a toxicologist who is head of the chemical hazard assessment team at the Food and Drug Administration, said the agency was reviewing its seafood mercury warnings. Because it has been four years since the advisory was issued, he said, "we have had a study under way to take a fresh look at it."
Tuna samples from the restaurants Nobu Next Door, Sushi Seki, Sushi of Gari and Blue Ribbon and the food store Gourmet Garage all had mercury in excess of one part per million, the "action level" at which the FDA can take food off the market. (In recent years, the FDA has rarely, if ever, taken any tuna off the market.)
The European Union can take tuna and other predatory and long-lived fish off the market at the same mercury concentration, one part per million.
Both Drew Nieporent, a managing partner of Nobu Next Door and Andy Arons, an owner of Gourmet Garage, were shocked by the Times' findings.
"I'm startled by this," said Nieporent. "Anything that might endanger any customer of ours, we'd be inclined to take off the menu immediately and get to the bottom of it."
Arons, whose stores stock yellowfin, albacore and bluefin, depending on the available quality and price, said, "We'll look for lower-level-mercury fish. Maybe we won't sell tuna sushi for awhile, until we get to the bottom of this."
At Blue Ribbon Sushi, Eric Bromberg, an owner, said he was aware that bluefin tuna had higher mercury concentrations. For that reason, he said, the restaurant typically tells parents with small children not to let them eat "more than one or two pieces."
Scientists who performed the analysis for The New York Times said they had been "frankly surprised" at the results and had run the tests several times to be sure there was no mistake in the levels of methylmercury, a form of mercury tied to health problems.
"No one should eat a meal of tuna with mercury levels like those found in the restaurant samples, more than about once every three weeks," said Dr. Michael Gochfeld, professor of Environmental and Occupational Medicine at the Robert Wood Johnson Medical School in Piscataway, New Jersey, who analyzed the sushi for the Times with Dr. Joanna Burger, professor of life sciences at Rutgers University.
The work was done at the Environmental and Occupational Health Sciences Institute, in Piscataway, New Jersey, a partnership between Rutgers and the Robert Wood Johnson Medical School. Gochfeld is a former chairman of the New Jersey Mercury Task Force. He also treats patients with mercury poisoning.
More than half of the restaurants and stores surveyed sold sushi with so much mercury that eating just six pieces a week would exceed the amount the Environmental Protection Agency says can be safely consumed by an adult of average weight, which the agency defines as 154 pounds, 70 kilograms. People weighing less are advised to consume even less mercury.
In general, tuna sushi from food stores was much lower in mercury. These findings reinforce results in other studies showing that more expensive tuna usually contains more mercury because it is more likely to come from a larger species that accumulates mercury from the fish it eats.
In the Times survey, 10 of the 13 restaurants said at least one of the two tuna samples purchased had been bluefin. (It is hard for anyone but experts to tell whether a piece of tuna sushi is bluefin by looking at it.) By contrast, other species, like yellowfin, bigeye and albacore, generally have much less mercury. Several of the stores in the Times sample said the tuna in their sushi was yellowfin.
"It is very likely bluefin will be included in next year's testing," said Dr. Bolger of the FDA. "A couple of months ago, FDA became aware of blue fin tuna as a species Americans are eating."
Studies have found high blood mercury levels among people eating a diet rich in seafood. According to a 2007 survey by the New York City Department of Health and Mental Hygiene, the average level of mercury in New Yorkers' blood is three times as high as the national average. The report found especially high levels among Asian New Yorkers, especially foreign-born Chinese, and people with higher incomes.
The report noted that Asians tended to eat more seafood and speculated that wealthier people favored certain fish, like swordfish and bluefin tuna, with higher mercury levels.
The city has warned children and women who are pregnant or breastfeeding not to eat any fresh tuna or Chilean sea bass or several other fish it describes as "too high in mercury."
Kate Mahaffey, a senior research scientist in the office of science coordination and policy at EPA who studies mercury in fish, said she was not surprised by reports of high concentrations.
"We have seen exposures occurring now in the United States that have produced blood mercury a lot higher than anything we would have expected to see," she said. "And this appears to be related to consumption of larger amounts of fish that are higher in mercury than we had anticipated."
Many experts believe the government's warnings on mercury in seafood do not go far enough. "The current advice from the FDA is insufficient," said Dr. Philippe Grandjean, adjunct professor of environmental health at the Harvard School of Public Health and head of the Department of Environmental Medicine at the University of Southern Denmark. "In order to maintain reasonably low mercury exposure you have to eat fish low in the food chain, the smaller fish, and they are not saying that."
Some environmental groups have already sounded the alarm. Environmental Defense, the advocacy group, says no one should eat bluefin tuna.
Others take a less absolute position. "I like to think of tuna sushi as an occasional treat," Gochfeld said. "A steady diet is certainly problematic. There are a lot of other sushi choices."
Your average American will leap all over the idea of anything that will (sing it with me if you know the words) "break our dependence on foreign oil." However, your average American hasn't thought about (1) what a bad idea it is to drive up the price of corn; (2) what a bad idea it is to incentivize Monsanto to make more genetically modified corn, which makes pests stronger in the long run; and (3) what a bad idea it is to incentivize poor nations to grow only one crop (corn).
BANGKOK, Thailand (AP) -- The world's rush to embrace biofuels is causing a spike in the price of corn and other crops and could worsen water shortages and force poor communities off their land, a U.N. official said Wednesday.
Speaking at a regional forum on bioenergy, Regan Suzuki of the U.N.'s Food and Agriculture Organization acknowledged that biofuels are better for the environment than fossil fuels and boost energy security for many countries.
However, she said those benefits must be weighed against the pitfalls - many of which are just now emerging as countries convert millions of acres to palm oil, sugar cane and other crops used to make biofuels.
"Biofuels have become a flash point through which a wide range of social and environmental issues are currently being played out in the media," Suzuki told delegates at the forum, sponsored by the U.N. and the Thai government.
Foremost among the concerns is increased competition for agricultural land, which Suzuki warned has already caused a rise in corn prices in the United States and Mexico and could lead to food shortages in developing countries.
She also said China and India could face worsening water shortages because biofuels require large amounts of water, while forests in Indonesia and Malaysia could face threats from the expansion of palm oil plantations.
"Particularly in the Asia-Pacific region, land availability is a critical issue," Suzuki said. "There are clear comparative advantages for tropical and subtropical countries in growing biofuel feed stocks but it is often these same countries in which resource and land rights of vulnerable groups and protected forests are weakest."
Initially, biofuels were held up as a panacea for countries struggling to cope with the rising cost of oil or those looking to reduce greenhouse gas emissions. The European Union, for example, plans to replace 10 percent of transport fuel with biofuels made from energy crops such as sugar cane and rapeseed oil by 2020.
But in recent months, scientists, private agencies and even the British government have said biofuels could do more harm than good. Rather than protecting the environment, they say energy crops destroy natural forests that actually store carbon and thus are a key tool in the fight to reduce global warming.
Some of those doubts were on display Wednesday at the U.N. forum, with experts saying many countries in Asia have rolled out plans to mandate biofuels for transport without weighing the potential risks.
Thailand, for example, is considering delaying the introduction of diesel blended with 2 percent biofuel for two months until April because of palm oil shortages, while the Philippines is considering shelving a biofuels law over concerns about the negative environmental effects.
India is facing criticism that its plans to plant 30 million acres of jatropha trees by 2012 for biofuel could force communities from their land and worsen deforestation. There are also concerns that it will be unable to find the 100 million acres of vacant land it needs to grow the shrub-like plants.
Varghese Paul, a forest and biodiversity expert with the Energy and Resources Institute in India, said dependence on a single species is dangerous.
"An outbreak of pests and diseases could wipe out entire plantations in one stroke," Paul said.
Excellent work by Dow on making the Saginaw River undrinkable (and fish from that river unfit for consumption) for God knows how many years! Just to put this in perspective, the EPA found the concentration of dioxin in the Saginaw to be 1.6 MILLION parts per trillion. In laboratory tests, dioxin doubles the risk that a mouse will die at a concentration of ONE part per trillion (see my previous blog post here: http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!196.entry). This is why I will never eat fish again. (Well, this and the mercury.)
A dioxin find at the bottom of Michigan's SaginawRiver could be the highest level of such contamination yet discovered in U.S. rivers and lakes, according to a federal scientist involved in cleanup efforts downstream from a Dow Chemical Company plant.
A crew testing the Saginaw and Tittabawassee rivers discovered the sample, which measured 1.6 million parts of dioxin per trillion parts of water, the Saginaw News and the Detroit News reported last week.
That level is about 20 times higher than any other find recorded in the U.S. Environmental Protection Agency archives.
"There may be more surprises out there," said Milton Clark, a health and science expert for the EPA. "I'd be surprised if there's not more surprises out there."
State guidelines require corrective action on contamination above a thousand parts per trillion.
Dioxins are toxic byproducts of the manufacture of chlorine-based products, and some have been linked to cancer and other health problems.
Dow is already removing three dioxin concentrations along a six-mile (ten-kilometer) stretch of the Tittabawassee, a SaginawRiver tributary that winds through Dow's plant in Midland, Michigan.
The company also plans to remove the latest find, Dow spokesperson John C. Musser said.
"We don't believe there's any imminent or significant human health or environmental threat," Musser said.
Michigan health officials were worried enough about last week's announcement that they extended a fish consumption advisory already in effect for the TittabawasseeRiver to include the entire SaginawRiver and a portion of Lake Huron's SaginawBay, where both rivers' water ends up.
The advisory warns against eating carp, catfish, and white bass—fish that feed near the riverbed where contaminants are buried. It also suggests women of childbearing age and children avoid eating certain other types of fish.
Dioxin, a byproduct of pulp-and-paper chlorine bleaching and the manufacture and incineration of PVC plastic (vinyl), can cause cancer, disrupt hormonal systems, and produce developmental defects in humans, according to a new draft report from the EPA. Children's dioxin intake is proportionately much higher than adults' because the chemical accumulates in animal fats, including breast milk and dairy products. For those who eat large amounts of meats, fish and dairy products, the risk of developing cancer could be as high as 1 in 100, ten times higher than the agency's previous estimate. Reproductive effects were underscored by a report in Lancet finding that dioxin lowered the birth rate for male children in Seveso, Italy, the site of an explosion that rained dioxin.
While EPA recommends that mothers continue to breastfeed, as benefits outweigh health risks, it advises that all Americans reduce consumption of fatty animal foods.
Sources: Science News, 6/3/00; Washington Post, 5/17/00.
Very interesting--and disturbing. It seems that there is an association between living near power lines and developing childhood leukemia, at distances of up to 600 meters. The commentary by the British Medical Journal editor is calm and reasonable, and suggests possible explanations for this phenomenon. Just as you always suspected, it's a bad idea to live under power lines--or, as it turns out, even just somewhat close to them.
A major new study found that children whose birth address was within 200 meters of an overhead power line had a 70% increased risk of leukemia. Children living 200 to 600 meters away from power lines had a 20% increased risk. This indicates the danger from power lines is appreciably further from the lines than had been identified in previous studies. The study, which was partially funded by the power-line industry, mapped how far each child lived from a high voltage overhead power line. It compared the children who had cancer with a control group of 29,000 children without cancer, but who lived in comparable districts, Appearing in the June 2005 British Medical Journal, the study concludes there is a statistical link between EMF from power lines and leukemia. The study – a collaboration between the Childhood Cancer Research Group at the University of Oxford and National Grid owners, Transco – looked at cancer data or children aged up to 15 years old in England and Wales between 1962 and 1995.
I threw up so often when I was pregnant with my daughter that I couldn't imagine drinking coffee--I think I drank two cups of decaf during the whole pregnancy--but here's another reason to quit using the last legal drug while you're pregnant.
Pregnant women have been warned to lay off the coffee after US researchers found that those who "drink two or more cups of coffee a day have twice the risk of having a miscarriage as those who avoid caffeine".
The study led by Dr De-Kun Li of Kaiser Permanente Division of Research, which appears in the American Journal of Obstetrics and Gynecology, concludes that an intake of 200 milligrams or more per day, representing two or more cups, "significantly increases the risk of miscarriage".
Li told Reuters: "There has been a lot of uncertainty about this. There was no firm advice from professional societies to say what a pregnant woman should do about caffeine intake."
He duly cautioned: "Women who are pregnant or are actively seeking to become pregnant should stop drinking coffee for three months or hopefully throughout pregnancy."
Li explained that while other studies have demonstrated a link between caffeine and miscarriage, the link had been "clouded by the fact that many pregnant women avoid caffeine because it makes them nauseated, which could skew the results".
Accordingly, Li and his team legislated for that possibility during their study of 1,063 pregnant women who were members of the Kaiser Permanente health plan in San Francisco from October 1996 to October 1998, and who "never changed their caffeine consumption during pregnancy".
The link between caffeine and misscarriage may be, according to Li, that the chemical stresses the unborn child's immature metabolism and possibly decreases blood flow in the placenta.
Dr Tracy Flanagan, director of women's health at Kaiser Permanente Northern California, backed Li's call to cut out the coffee, concluding: "So many causes of miscarriage are not controllable. This is an opportunity to do something active."
Wow, what a surprise that frequent exposure to radiation could be detrimental to your health? I remember the first time someone's mobile phone went off during a lecture when I was in college (circa 1998). The first thought that crossed my mind was, "Who the hell are you that you're so important that you need to have your phone on during class? You're a college kid, for crying out loud." Maybe more kids need to spend more time with their phones off.
Radiation from mobile phones damages sleep and causes headaches, according to a study by telephone makers.
People using a handset before going to bed take longer to reach deeper stages of sleep and spend less time in them, researchers found.
This gives their bodies less time to repair wear and tear during the day, and gives them headaches.
The findings are particularly alarming for children and teenagers, most of whom, surveys suggest, use their phones late at night.
The young need plenty of sleep and failure to get enough can lead to depression and poor academic achievement.
The scientists concluded: "The study indicates that during laboratory exposure to 884 MHz wireless signals, components of sleep, believed to be important for recovery from daily wear and tear, are adversely affected.
"Moreover, participants that otherwise have no self-reported symptoms related to mobile phone use appear to have more headaches during actual radio frequency exposure."
The research, funded by the Mobile Manufacturers Forum, which represents the main handset companies, has caused serious concern among sleep experts.
The study, involving 35 men and 36 women aged between 18 and 45, was carried out by scientists from Uppsala University in Sweden and Karolinska Institute and Wayne State University in Michigan, USA.
Actually, Monsanto's genetically engineered corn is probably doing some of the work, too, but this article from Penn State University researcher Maryann Frazier shows (complete with citations) exactly which Bayer-produced pesticides are known to be toxic to honeybees. Great job, Big Pharma! You're not just killing bees--you're killing us.
You may be wondering why the mainstream press (including the Times) hasn't found Ms. Frazier's article, and the answer seems to be that (once again) money talks. How much does Bayer give to our government? Let's just see... (http://www.capitaleye.org/bio-bayer.asp):
Aspirin-maker Bayer has expanded into the world of biotechnology. Although the company sells a few biotech drugs, its main interest is in genetically modified crops. Bayer acquired its crop science division from Aventis, which sold it shortly after some of its genetically modified corn, not approved for human consumption, somehow got into the food supply. Bayer CropScience produces genetically modified corn and canola, and plans to have biotech rice on the market within the next few years. The company contributed to the campaign to block Oregon's proposed food labeling law in 2002 and has lobbied the Bush administration to pressure the European Union to accept biotech foods.
Pharmaceutical giant Eli Lilly is promoting Sarafem as a miracle pill for women suffering from PMDD, a ‘mental disorder’ not yet proved to exist. What’s more, Eli Lilly admits that Sarafem has the same active ingredient as Prozac, complete with the same dangerous side effects.
Australian-born singer Helen Reddy’s 1972 hit song “I Am Woman” has been called a feminist battle hymn. Many a male disc jockey at the time refused to air it until the song became part of the soundtrack to a movie and catapulted to the top of the Billboard charts. Taking a look at the song today, it’s hard to imagine the furor generated by the lyrics from the lady down under:
“Oh, yes, I am wise, but it’s wisdom born of pain. “Yes, I’ve paid the price, but look how much I gained. “If I have to I can do anything. “I am strong. I am invincible. I am woman.”
Nearly three decades since the release of this feminist anthem the lyrics neither threaten nor offend — if they ever did — but seem to acknowledge pride in feminine strength. As if it needed to be said, historians agree on the significance of women in the building of this nation. The Jamestown settlement, for instance, was a disaster and on the brink of failure until women were added to the new colony. The West was won by men and women working side by side, and the United States triumphed over its enemies in World War II with the help of nearly 500,000 women in the ranks and millions more in the factories.
Not surprisingly, women achieved these feats completely unaware that a few days out of each month they were suffering from a mental disorder. That’s right. The Food and Drug Administration (FDA) recently approved the use of Sarafem (fluoxetine) for women suffering from a mental disorder just three or four days a month — in the “luteal phase” or just before the onset of menses.
This “mental disorder” — which the American Psychiatric Association (APA) has not yet accepted, but which is listed in the appendix of the APA’s Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) — is called premenstrual dysphoric disorder, or PMDD. It’s a new-and-improved version of premenstrual syndrome (PMS), which also has not made it to the hit parade of the official APA list of mental illnesses. The fact that PMDD is listed only in the diagnostic manual’s appendix reflects the APA’s desire for further research before accepting it as a full-fledged mental disorder.
According to the DSM-IV and the FDA, a woman must experience five or more symptoms before the diagnosis can be made. The unofficial mental disorder is said to be characterized by the following symptoms:
* Markedly depressed mood * Marked anxiety * Marked affectivity * Decreased interest in activities * Feeling sad, hopeless or self-deprecating * Feeling tense, anxious or “on edge” * Persistent irritability, anger and increased interpersonal conflicts * Feeling fatigued, lethargic or lacking in energy * Marked changes in appetite * A subjective feeling of being overwhelmed or out of control * Physical symptoms such as breast tenderness, swelling or bloating.
Eli Lilly and Co., the Indianapolis-based pharmaceutical company that makes Sarafem, has been marketing the “new” treatment with such gusto that there are jokes about the company exhibiting obsessive-compulsive disorder. It seems there isn’t a magazine to be picked up or a channel to be surfed that isn’t running a Sarafem advertisement.
These ads show women expressing many things. One TV spot depicts a woman trying to button her slacks and looking angry and agitated. Another scene shows a woman snapping at her husband, “Just leave me alone,” while still another involves a woman slumped on the couch sobbing. Then there is the slogan: “Sarafem — More like the woman you are.”
Lilly reports in its ads that now, “Doctors can treat PMDD with Sarafem — the first and only prescription medication for PMDD.” The ad further states that, “Sarafem contains fluoxetine hydrochloride, the same active ingredient found in Prozac.” But both Sarafem and Prozac are fluoxetine hydrochloride. According to Laura Miller, marketing associate for Eli Lilly, “Fluoxetine hydrochloride is the same active ingredient in Sarafem as in Prozac.” Again and again Insight asked, “Then is it the same thing?” Again and again Miller only repeated that the two identical doses of fluoxetine hydrochloride have the same active ingredient.
Miller refused to acknowledge that Sarafem is just Prozac repackaged, or that the pill color was changed from green to feminine pink and lavender to market it for a not-yet-approved “mental disorder” that never before existed. The Lilly representative did say the difference in the treatments is in “how women react to the drug.”
Never mind that all this dramatic hype, supported by millions of dollars in marketing, has occurred just before Lilly loses its exclusivity on Prozac in August.
“We asked women and physicians,” says Miller, “about the treatment of PMDD, and they told us they wanted a treatment option with its own identity that would differentiate PMDD from depression. [Prozac is the most common treatment for depression and has been available since 1987.] PMDD is not depression. As you know, Prozac is one of the best-known trademarks in the pharmaceutical industry and is closely associated with depression. They wanted a treatment option with its own identity.”
But what is the difference, Insight asked Miller, if a woman takes 20 milligrams (mg) of Prozac (fluoxetine hydrochloride) for depression or 20 mg of Sarafem (fluoxetine hydrochloride) for PMDD? “The difference,” explains Miller, “is that PMDD is a distinct clinical condition different than depression. PMDD is not depression.”
What’s the difference if it’s the same drug? “PMDD,” continues Miller, “is cyclical — women suffer from PMDD up to two weeks before their menses, and the other two weeks of the month they don’t have the symptoms of PMDD.” Hmm, so they are crazy “up to” half the time! In any case, if the Lilly representative is correct, ask critics, why is Sarafem/Prozac prescribed for every day of the month for as long as it takes to eliminate the PMDD symptoms — which could be years.
Pressed to explain the difference in the two drugs, not the disorders, Miller suggests Insight speak with women who have PMDD. She flatly refuses to clarify any pharmacological difference between Sarafem and Prozac. More importantly, how can one offer a treatment for a mental disorder (PMDD) before it is determined that it exists?
According to Lilly’s own literature there is no science to support the diagnosis. “While it is unknown what causes PMDD, many doctors believe it may be related to an imbalance in a natural chemical in the body called serotonin. The actions of Sarafem on serotonin may explain its effects in improving the symptoms of this condition.”
The “science” that Lilly forwarded to Insight included a position paper from the American College of Gynecologists (ACOG) citing several clinical studies and an article published last year in Lancet, a prestigious British medical journal. The ACOG paper, “Premenstrual Syndrome,” and the Lancet article, “Efficacy of Selective Serotonin-Reuptake Inhibitors (SSRIs) in Premenstrual Syndrome: A Systematic Review,” suggest the efficacy of treating PMDD in women with SSRIs (Sarafem/Prozac).
The point is that when asked if Lilly has the science to prove that PMDD exists and that Sarafem is anything but a mind-altering drug, Lilly responded instead by pointing to controlled clinical trials involving SSRIs and placebos. While there are many trials supporting the efficacy of SSRIs in making women said to have PMS/PMDD “feel better” in the two weeks before menstruation, no indication is provided that this effect is anything but a psychotropical masking of discomfort.
According to Renay Tanner, a respected researcher in the field who holds a bachelor’s degree in biological sciences, a master’s in sociomedical sciences and is finishing her doctorate in sociomedical sciences at Columbia University, “PMDD is a socially constructed disease. There is no MRI [magnetic resonance imaging], X-ray, blood test, etc. [to confirm that it even exists]. There is nothing scientific about this.” Women feel differently when on SSRIs, Tanner explains, “because of what are commonly known as the side effects of these drugs. This does not indicate that the patient is ‘better’ by any scientific standard. How can a drug that is used to treat separation anxiety in dogs also be used to treat PMDD? This is an insult to women. It’s almost mind-boggling that all these physicians are playing along.”
Tanner tells Insight that promotion of fluoxetine hydrochloride to treat PMDD as a mental disease “is an example of a health-care system driven by the maximization of profits, not by what works. The patient has be-come a commodity. The bigger picture is that such greed-centered medicine is leading to human- and civil-rights abuses at a phenomenal rate, ranging from disability discrimination in the workplace and educational institutions to coerced drugging of individuals by the legal system. Prozac is being prescribed for everything: It’s like snake oil. They have a drug, they come up with a disease and then they come up with the science to justify using the drug as treatment. There is something very wrong with this.”
Robert Whitaker is an award-winning author of a series written for the Boston Globe about research, pharmaceutical companies and the mentally ill, as well as author of the soon-to-be-released book Back to Bedlam — a look at the failure of modern medical treatments of schizophrenia. He tells Insight, “This sort of thing is becoming very common. With PMDD you’re talking about the extreme end of something normal in life — regular ups and downs. But you see it time and again.” Sarafem, explains Whitaker, “is a mind-altering drug, and it has all kinds of adverse side effects — the most immediate being sexual dysfunction, but the primary effect is altering emotion. No one knows how the brain reshapes itself in response to the drug, and let’s remember we’re talking about symptoms of a type that are very common.”
The drug, Whitaker further explains, “cannot differentiate the diagnosis in the brain. Whether you have depression, PMDD or no mental disorder, this drug will make you feel different. The reduction in symptoms is a subjective measurement in the sense that there is no easy way to measure irritability. Calling it Sarafem rather than Prozac is misleading and unethical. It hides what is known about the side effects of Prozac. It is profound intervention. This is at least in part about selling drugs — making sure you have a flow of patients who have been taught that they should have a miracle pill. Today we believe in mind pills —it’s a kind of worship of the day. But people know about Prozac, and they know it has serious consequences.”
Just how serious are the adverse effects of Prozac? Houston attorney Andy Vickery of Vickery & Waldner (www.justiceseekers.com) has spent a great deal of time researching what he believes is a deadly serious question. Vickery has represented numerous clients in lawsuits where Prozac was alleged to be the cause of violent deaths, including Forsyth v. Eli Lilly.
“Lilly” says Vickery, “has avoided all but two trials out of hundreds of lawsuits by settling out of court or having the suits dismissed.”
Bill Forsyth spent two days on Prozac and was taken to the hospital by his son, who testified that his father reported having weird thoughts about knives and had mentioned this while being admitted to the hospital. Forsyth remained in the hospital for seven days, where the Prozac was continued, and then was released. He returned home, stabbed his wife of 37 years 15 times, then impaled himself on a butcher knife and died.
In April 1999, Lilly won in the Forsyth case. However, the Forsyth family has filed a new lawsuit to set aside the judgment on the grounds that it was obtained by defrauding the court. According to a press release put out by Vickery & Waldner, “The suit alleges that critical information was withheld from the judge and jury.”
Specifically, the new lawsuit notes that Lilly agreed to pay $90 million for a patented new Prozac molecule to reduce certain side effects of the original Prozac, including “nervousness, anxiety, insomnia, inner restlessness, suicidal thoughts, self-mutilation and manic behavior.” But, contends the lawsuit, a Lilly in-house patent lawyer sat mutely in the courtroom while Lilly’s trial counsel told the judge and jury that suicide is not a side effect of Prozac.
In other words, Lilly consistently has denied that Prozac causes suicidal thoughts, but has a new Prozac patent to improve the original by eliminating its potential to cause suicidal thoughts. According to Vickery, who also has filed suit against Lilly for fraud, the pharmaceutical company now has dropped interest in the new patent.
It also was during the Forsyth trial’s closing arguments that Vickery first made public a time line of Lilly’s internal documents, obtained in discovery, that he says confirms Lilly has been aware of Prozac-induced suicidal thoughts and violence. The time line begins in 1978 and continues until 1998 — a year before the judgment in the Forsyth case. Perhaps the most revealing internal document is one dated Jan. 30, 1999, that Vickery explains is a letter giving sales representatives a heads-up on a forthcoming article regarding Prozac and suicide.
It instructs them as follows: “Because these issues [suicide] are not part of our current marketing plan, you should not initiate discussions on these articles. ... Again, because these issues are not part of our current marketing plan, discussions should not be initiated by you.”
Asked if this information was made available to the FDA during the approval process for Prozac, FDA Public Affairs Specialist Susan Cruzan tells Insight, “The issue was thoroughly investigated by the FDA, and the safety and effectiveness is taken into consideration. All side effects and safety information are taken into consideration.”
The internal documents presented in the Forsyth case are not the only indication that there may be a strong association between Prozac and suicidal behavior. Psychologist Blake Tracy, a Ph.D. who is author of Prozac: Panacea or Pandora (www.drug
awareness.com), reports that, “according to FDA spokespersons, there have been more adverse-reaction reports on Prozac than any other medical product. As of October 1993, a total of 28,623 complaints of adverse side effects had been filed with the FDA, including 1,885 suicide attempts and 1,349 deaths.”
Tracy further reported that the “FDA’s general rule of thumb for estimating the true figures is that these reports represent only 1 to 10 percent of the actual figures.” Insight requested updated information from the FDA on the number of adverse reactions reported on Prozac but was told it would not make that information available until requested in writing under the Freedom of Information Act.
Paula Caplan is an affiliated scholar at Brown University’s Pembroke Center for Research and Teaching on Women, and the author of nine books including, They Say You’re Crazy: How the World’s Most Powerful Psychiatrists Decide Who’s Normal. She tells Insight that, “I’ve written and said it many times: There is no such thing as premenstrual mental illness.” Caplan says, “No one has ever found any evidence that PMDD exists, let alone PMS. Why do we focus on women’s cycles even though there is no data to support that women get more angry or aggressive than men at a certain time of the month? And why are they blaming it on serotonin instead of hormones?”
According to Caplan, “Prozac has been prescribed for everything — anorexia, depression, obesity, obsessive-compulsive disorder. Apparently it’s good for whatever ails you. But to say that a large number of women are crazy once a month is demonizing and demoralizing to women.”
It also is highly profitable for Eli Lilly, which is spending millions to hype that idea in a way that will sell Sarafem. And the fact is, according to the Wall Street Journal last year, 84 percent of women who ask their physician for a drug by name leave the office with a prescription for it.
Antidepressants Under Scrutiny Over Efficacy Sweeping Overview Suggests Suppression of Negative Data Has Distorted View of Drugs By DAVID ARMSTRONG and KEITH J. WINSTEIN January 17, 2008; Page D1
The effectiveness of a dozen popular antidepressants has been exaggerated by selective publication of favorable results, according to a review of unpublished data submitted to the Food and Drug Administration.
ACCENTUATE THE POSITIVE
A review of research submitted to the FDA: • Of 74 studies reviewed, 38 were judged to be positive by the FDA. All but one were published, researchers said. • Most of the studies found to have negative or questionable results were not published, researchers found. Source: The New England Journal of MedicineAs a result, doctors and patients are getting a distorted view of how well blockbuster antidepressants like Wyeth's Effexor and Pfizer Inc.'s Zoloft really work, researchers asserted in this week's New England Journal of Medicine.
Since the overwhelming amount of published data on the drugs show they are effective, doctors unaware of the unpublished data are making inappropriate prescribing decisions that aren't in the best interest of their patients, according to researchers led by Erick Turner, a psychiatrist at Oregon Health & Science University. Sales of antidepressants total about $21 billion a year, according to IMS Health.
Wyeth and Pfizer declined to comment on the study results. Both companies said they had committed to disclose all study results, although not necessarily in medical journals. GlaxoSmithKline PLC, maker of Wellbutrin and Paxil, said it has posted the results of more than 3,000 trials involving 82 medications on its Web site, and also has filed information on 1,060 continuing trials at a federal government Web site.
Schering-Plough Corp., whose Organon Corp. unit markets Remeron, and Eli Lilly & Co., which makes Prozac, said their study results were indeed published -- not individually, but as part of larger medical articles that combined data from more than one study at a time. The New England Journal study counted a clinical trial as published only if it was the sole subject of an article. "Lilly has a policy that we disclose and publish all the results from our clinical trials, regardless of the outcomes from them," a Lilly spokeswoman said.
Pharmaceutical companies are under no obligation to publish the studies they sponsor and submit to the FDA, nor are the researchers they hire to do the work. The researchers publishing in the New England Journal were able to identify unpublished studies by obtaining and comparing documents filed by the companies with the FDA against databases of medical publications.
"There is no effort on the part of the FDA to withhold or to not post drug review documents," an FDA representative said. For newer drugs, information is posted online "as soon as possible." Older documents aren't always available online and efforts to add those files to the Web are slowed by "a lack of resources," the agency said, acknowledging that there is a backlog in complying with records requests.
A total of 74 studies involving a dozen antidepressants and 12,564 patients were registered with the FDA from 1987 through 2004. The FDA considered 38 of the studies to be positive. All but one of those studies was published, the researchers said.
The other 36 were found to have negative or questionable results by the FDA. Most of those studies -- 22 out of 36 -- weren't published, the researchers found. Of the 14 that were published, the researchers said at least 11 of those studies mischaracterized the results and presented a negative study as positive.
Five Trials
For example, Pfizer submitted five trials on its drug Zoloft to the FDA, the study says. The drug seemed to work better than the placebo in two of them. In three other trials, the placebo did just as well at reducing indications of depression. Only the two favorable trials were published, researchers found, and Pfizer discusses only the positive results in Zoloft's literature for doctors.
One way of turning the study results upside down is to ignore a negative finding for the "primary outcome" -- the main question the study was designed to answer -- and highlight a positive secondary outcome. In nine of the negative studies that were published, the authors simply omitted any mention of the primary outcome, the researchers said.
The resulting publication bias threatens to skew the medical professional's understanding of how effective a drug is for a particular condition, the researchers say. This is particularly significant as the growing movement toward "evidence-based medicine" depends on analysis of published studies to make treatment decisions.
Colleagues' Questions
Dr. Turner, who once worked at the FDA reviewing data on psychotropic drugs, said the idea for the study was triggered in part by colleagues who questioned the need for further clinical drug trials looking at the effectiveness of antidepressants.
"There is a view that these drugs are effective all the time," he said. "I would say they only work 40% to 50% of the time," based on his reviews of the research at the FDA, "and they would say, 'What are you talking about? I have never seen a negative study.'" Dr. Turner, said he knew from his time with the agency that there were negative studies that hadn't been published.
The suppression of negative studies isn't a new concern. The tobacco industry was accused of sitting on research that showed nicotine was addictive, for instance. The issue has come up before notably with antidepressants: In 2004, the New York state attorney general sued GlaxoSmithKline for alleged fraud, saying it suppressed studies showing that the antidepressant Paxil was no better than a placebo in treating depression in children. Glaxo denied the charge and eventually settled with the attorney general. The company later posted on its Web site the full reports of all of the studies of Paxil in children.
But publication of negative studies is an issue that cuts across all medical specialties. And it has engendered some strong reactions in the medical-research world: To make it harder to conceal negative study findings, an association of medical journal editors began requiring in 2005 that clinical trials be publicly disclosed at the outset to be considered for publication later. The system isn't foolproof, since manufacturers often run exploratory studies without registering them and can selectively disclose favorable results. The rule only applies to studies intended for publication in a medical journal.
Some studies that don't eventually get published are registered with online trial registries, including the federal government's www.clinicaltrials.gov. Nonetheless, many studies still aren't being registered or reported, says Kay Dickersin, the director of the Center for Clinical Trials at the Johns Hopkins Bloomberg School of Public Health. "We need something more meaningful," she said. "The average person has no idea that www.clinicaltrials.gov is not comprehensive."
The New England Journal study also points to the need for the FDA to disclose more information about the studies it receives, says Robert Hedaya, a professor of clinical psychiatry at Georgetown University Hospital. He said it was "disturbing" that the information on the negative studies wasn't made widely available by the FDA.
The FDA does post information, including unpublished studies, for some drugs on its Web site, says Dr. Turner. But information that hasn't yet made it online is hard to come by. Dr. Turner said he made public records requests for information not on the Web site more than a year ago, but the requests have gone largely unfulfilled. He said he was able to get some of the FDA's information on unpublished studies from other researchers who acquired it from the agency through their own record requests.
The 'Effect Size'
In this week's study, the researchers found that failing to publish negative findings inflated the reported effectiveness of all 12 of the antidepressants studied, which were approved between 1987 and 2004. The researchers used a measurement called effect size. The larger the effect size, the greater the impact of a treatment.
The average effect size of the antidepressant Zoloft rose 64% by the failure to publish negative or questionable data on the drug, the researchers found.
Nice job, guys! Telling women they're crazy for having a natural response to a hormonal change, just so you can extend your patent for anti-depressants. Good to know, also, that Big Pharma reps take part in creating new mental illnesses (see the highlighted portions of the article below).
Researchers, physicians and psychologists fall on various sides of the debate over premenstrual dysphoric disorder.
BY JENNIFER DAW Monitor staff
"I'm so bloated." "I'm so depressed." "I'm so irritable." "One minute I'm fine, the next I'm crying." "I'm so tired."
The list of complaints that goes with many women's menstrual cycle can be long. Most women--and men for that matter--are quick to diagnose these symptoms as premenstrual syndrome (PMS)--a catchall diagnosis that's tossed around to describe all sorts of minor mood and menses-related maladies in women.
But approximately 3 to 9 percent of women experience premenstrual changes so severe they can't keep up their daily routines. Some experts say these women suffer from premenstrual dysphoric disorder (PMDD), a condition characterized by intense emotional and physical symptoms that occur between ovulation and menstruation. In other words, PMDD is like supercharged PMS.
Eight years ago it was included in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). But many health professionals say PMDD does not exist, that it can be confused with other mental health disorders, such as depression. Psychologists in this camp contend women shouldn't have to be diagnosed with a mental illness in order for others to believe they are uncomfortable or unhappy or to get help and support.
"PMS and PMDD are both 'culture-bound' syndromes," says Joan Chrisler, PhD, a psychology professor at ConnecticutCollege and president of the Society for Menstrual Cycle Research. "There is no evidence [that PMDD exists], though people have to find such evidence," says Paula Caplan, PhD, author of "They Say You're Crazy" (1995, Perseus Books). "It is really appalling that using PMDD for women who want recognition for discomfort is a very clear message that goes something like: 'OK, OK, we'll believe you are feeling bad if we get to call you mentally ill for feeling bad.' Can you imagine if we did that to men?"
"Women are supposed to be cheerleaders," she adds. "When a woman is anything but that, she and her family are quick to think something is wrong."
Jean Endicott of Columbia Presbyterian Medical Center and a panel of experts determined in 1999 that PMDD is a distinct clinical entity, based on studies they examined that suggested that PMDD sufferers have "normal functioning of the hypothalamic-pituitary-adrenal axis, show biologic characteristics generally related to the serotonin system, and a genetic component unrelated to major depression." The roundtable group--which included psychiatrists, psychologists and a representative from Eli Lilly--also cited studies that showed that at least 60 percent of patients respond to selective serotonin reuptake inhibitors (SSRIs) as evidence of PMDD's distinct clinical entity.
Interestingly, a 1998 (American Journal of Obstetrics and Gynecology, Vol. 179, No. 2) study showed that calcium carbonate could improve PMDD symptoms. Out of approximately 500 women, 55 percent experienced some relief from some symptoms within three months.
Bad for women?
Some feminist psychologists like Caplan believe that the language surrounding PMDD is misleading and that its classification as a psychiatric disorder stigmatizes women as mentally ill and covers up the real reasons of women's anguish. "It's a label that can be used by a sexist society that wants to believe that many women go crazy once a month," Caplan explains.
By including PMDD in the DSM-IV, she says, emotional displays that are considered normal in men are seen as a mental disorder in women. "Any normal hormonal change in people of either sex can exacerbate migraines, thyroid problems, etc., but no one suggests calling...men's hormonal changes kinds of mental illness."
Chrisler agrees, noting that not only is the diagnosis part of a "backlash against feminism," it undermines women's self-concepts and feeds into stereotypes about women. "It's convenient for women to use this," says Chrisler. "The discourse is me, not me, my real self, my PMS self. It allows you to hold onto a view of yourself as a good mother who doesn't lose her temper."
Caplan cites research by Sheryle Gallant and colleagues "that demonstrates without question that the category of PMDD is neither valid nor helpful to women." The study (Psychosomatic Medicine, 1992) asked women--a group that said they had severe symptoms and a group with none--to keep a checklist of PMDD symptoms. In the end, the checklist responses failed to differentiate the two groups.
Perhaps most interesting, some men were asked to participate in the study and their checklist results didn't differ from the women's. Caplan says that's "dramatic proof" that classifying PMDD as mental disorder is "unjustified."
Chrisler and Caplan say that health professionals are all too ready to diagnose women with PMS or PMDD. "The diagnosis is vastly overextended," Chrisler says. "The definition says it has to be severe and interrupt your life. No one thinks about that anymore."
Caplan says that when someone believes they have PMDD, a psychologist should say, "'Yes, maybe that's it. But let's look at your life, maybe it's something else.'"
Indeed, some research seems to show that many women who seek treatment for PMS or PMDD are often abused. At the least, Chrisler says, they might be experiencing stress that exacerbates premenstrual changes--but they don't really have PMDD. She adds: "We're conditioned to want a pill. Instead of something you might need more, like a nap or a divorce, or the ERA."
Enter the drug treatments
Two medications are approved by the Food and Drug Administration to treat PMDD: Sarafem (fluoxetine) and Zoloft (sertraline HTL). Sarafem--repackaged Prozac--was marketed heavily by its manufacturer, Eli Lilly, for PMDD treatment after it acquired another patent--Prozac's patent was due to expire. Lilly spent more than $33 million promoting the drug to consumers. In the seven-month period after the medication's approval, physicians doled out more than 200,000 prescriptions for Sarafem.
And this year, Zoloft, manufactured by Pfizer, was also approved to treat the condition.
But drug treatments for PMDD draw controversy. Critics like Caplan think drug companies are taking advantage of women's health concerns and fears to increase their bottom lines. She thinks the decision to accept Sarafem as a treatment for PMDD just furthers "the misleading and dangerous assumption that the condition even exists"--women's underlying problems, such as depression or abuse go untreated, she says. Caplan also asserts that many drug companies have funded studies, "then insisted that, as reported by the editors of major medical journals in the past two years, researchers publish only those studies that showed their drug works, and they have suppressed the publication of others." And she notes that if a company does enough studies, "one will by statistical chance get some that seem to show the drug makes a difference.
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