Health Supreme by Sepp Hasslberger

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January 31, 2005

Acne Medicine 'Accutane' Causing Birth Defects, Depression, Suicides

Accutane, a medicine for acne, is causing birth defects, depression and suicides, allege researchers. Dr. David Graham, associate director of the FDA's office of drug safety, named Accutane as one of the drugs he says should be restricted or withdrawn from the market, according to this article in the Washington Post. In a Tampa, Florida legal case against Hoffmann LaRoche, a host of documents on Accutane's effects has been produced by the drug maker. Unfortunately, federal judge James Moody ruled that documents filed in the case could not be "passed on" to others who have similar legal cases pending.

The drug has caused scores of birth defects, which are acknowledged by the company in its product information. According to a report of Vera Hassner Sharav of the Alliance for Human Research Protection, the FDA in 2002 had knowledge of 173 suicide reports associated with Accutane. The manufacturer says the drug is safe.

Hold on a minute. An acne drug associated with deadly side effects? Acne is by no means a life-threatening condition. Babies being born deformed for life, hundreds, and possibly thousands of young people committing suicide? What could induce our health authorities to allow deadly drugs such as Accutane on the market, when on the other side they are campaigning to limit the availability of vitamins, minerals and other nutrients?

Money? Double standard? I haven't been able to make sense of this...

- - -

Promoting Openness, Full Disclosure, and Accountability

Judge James Moody, A federal judge in Tampa, Florida, ruled against plaintiff lawyers who sought to share internal documents belonging to Hoffman-LaRoche that show the company knew about the increased suicide risk associated with the acne drug, Accutane.

The company’s own safety experts had recommended in 1997 changing the US label to reflect the evidence that Accutaine “probably caused” depression and other psychiatric illnesses in some patients.”  USA Today reported (December 7, 2004) that Hoffman’s head of regulatory affairs testified in court that the marketing division argued that such a warning would “impact on marketing strategy and product liability.” The marketing division prevailed and no such warning was issued.  (see:

Accutane is one of five drugs that FDA’s senior safety officer, Dr. David Graham, named in his Senate testimony as a possible candidate for withdrawal from marketing.

USA Today published a chronology of Accutane findings:

For example, in 1999, Roche told the FDA that none of the 168 reports of suicidal behavior can be directly linked to Accutane.

In 2000, during an FDA dermatology committee meeting, the agency confirmed that 147 suicides were linked to patients taking Accutane.

In 2002, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told a congressional committee that the agency had received reports of 3,104 adverse psychiatric events involving Accutane and that the FDA knew of 173 suicide reports associated with Accutane.

Furthermore, USA Today reported that in 1988, Godfrey Oakley, director of the Division of Birth Defects and Developmental Disabilities at the Centers for Disease Control, wrote that "40 infants born alive after first trimester exposure to Accutane have died ... because of the developmental errors that Accutane caused." Oakley argued that "we simply need to remove the drug from the market."

In 2004, The Alliance for Human Research Protection asked Keith Altman, Adverse Drug Reaction Statistics Analyst, to analyze FDA's Medwatch database for drug-linked suicides by children under 18 years of age.

He found that between 1989 and June 2003, there were 216 reported drug-linked suicides in under 18 year olds. Of these, 72 suicides were linked to Accutane. The next highest number of suicides - 55—involved Prozac.

Since MedWatch reflects approximately 1% of actual adverse drug events, 72 Accutane suicide reports represent 7,200 suicides. And 55 Prozac-related suicide reports represent 5,500 suicides.

The judge indicated that attorneys could ask the court to open up records if they discover a matter of public safety as they prepare their cases. One wonders what standard the judge uses to determine when a drug hazard is “a matter of public safety?”

One also wonders why the FDA had failed to require disclosure to physicians that Accutane posed an increased suicide risk?

Contact: Vera Hassner Sharav

Acne Drug Memos Kept Secret Despite Suits

January 28, 2005 8:49 PM EST

(go to original)

TAMPA, Fla. - Lawyers suing the makers of Accutane over allegations the acne drug increases the risk of suicide cannot share the company's internal memos and other documents with the public or federal regulators, a judge ruled Friday.

The attorneys had sought to make public as many as 1 million documents produced by Hoffman-La Roche Inc., saying the disclosure was needed as Accutane's safety comes under increased scrutiny by the U.S. Food and Drug Administration.

U.S. District Judge James Moody rejected the request, saying attorneys could ask the court to open up records if they discover a matter of public safety as they prepare their cases. But in a victory for the plaintiffs, he said the drug maker cannot redact documents before handing them over to the attorneys.

Moody, based in Tampa, is presiding over the management of dozens of lawsuits filed nationwide over Accutane, used by about 5 million Americans.

The drug, which has been dispensed in the United States since 1982, has been blamed for increased rates of suicide and gastrointestinal diseases in some users and birth defects in babies born to mothers who took Accutane.

Hoffman-La Roche contends the drug is safe, although it recommends that users be screened for depression. The company notes that teenagers and young adults, the groups most likely to use the drug, have higher suicide rates than the general population.

The documents at issue include internal company discussions about the safety of the drug and how to handle allegations of an increased suicide risk.

Hoffman-La Roche attorney Ed Moss said the company fought the release of the documents mostly out of concern for protecting Accutane's "recipe," and that federal officials already have internal documents relating to the drug's safety.

"We are not trying to hide documents from the public," Moss said. "We have given everything in the world to the FDA."

FDA scientist David Graham testified before Congress last year that Accutane was one of five dangerous drugs that should be restricted or removed from the market. In November, federal regulators toughened rules on Accutane, requiring doctors and pharmacists who dispense the drug to register patients on a central database.

Among the Accutane cases is a $70 million lawsuit brought by the mother and grandmother of Charles Bishop, the 15-year-old who stole a small airplane and crashed into a Tampa high rise in January 2002. His family blames his use of the drug for bringing on the dramatic suicide, but the company contends that he was a troubled young man and it is not to blame.

Hoffman-La Roche Inc., based in Nutley, N.J., is the United States prescription drug unit of the Swiss drug maker Roche Group.

See also:

Roche puts Accutane profits over Lives of Consumers
In 1985, Accutane's package insert directed at doctors first mentioned reports of depression in patients taking the acne drug, which means that more than 20 years ago, Hoffman-LaRoche at least suspected there might be a risk of depression and suicide by persons taking the drug.

However, Roche's financial records show that the company is not about to let a little thing like the death of its customers get in the way of corporate profits, because the drug is still a best seller and young people with no history of depression who take it are still killing themselves.

One Man's Quest to Uncover the Toxic Secrets Behind Accutane

FDA puts stricter controls on acne drug
By Ricardo Alonso-Zaldivar - Los Angeles Times
WASHINGTON — Federal regulators yesterday unveiled a high-tech system to restrict distribution of Accutane, an acne drug taken by thousands of Americans. The drug has been particularly effective against severe acne, but has long been known to cause birth defects and is now being studied for a possible connection to teenage suicides.

22 August 2005: FDA poses stricter regulations for the acne drug Accutane
It is hoped that birth defects and miscarriages associated with the skin care drug Accutane will decrease under tight new laws from the FDA.

Family blame acne drug for death
From BBC News - 20 September 2005: The family of a student who hanged himself have blamed a drug he was taking to treat acne. David Roberts, 21, had been taking Roaccutane for two months when he hanged himself near his Liverpool home. Coroner Andre Rebello recorded a narrative verdict and said there was not enough evidence to link the death with the drug. Roaccutane's manufacturer Roche insists there is no proven relationship between the drug and depression. However, Mr Roberts' father, Fred Roberts, said he could think of no other explanation for the tragedy.

Accutane - Another Case of Too Little Too Late
Accutane is prescribed to treat a type of severe acne called nodular acne which causes red, swollen, tender lumps to form under the skin. Accutane is supposed to be used only when all other treatments, including antibiotics, have failed. The treatment usually lasts 4 or 5 months, at a cost of about $3000, including lab tests and doctor's visits. The drug is manufactured by Roche Pharmaceuticals and is also marketed under the generic names Amnesteem, Claravis, Isotretinoin, and Sotret. The FDA estimates that about 100,000 prescriptions for the drug are written in the US each month. Accutane has many side effects. Patients have been known to develop serious mental health problems and the FDA has acknowledged reports of suicide or suicide attempts associated with use of the drug...

Accutane linked to heart, liver risk
Accutane, the powerful acne drug already known to cause birth defects, seems to raise the risk for potential heart and liver problems more than doctors had expected, according to a new study.
The findings came from lab tests on 13,772 patients taking the popular acne drug and underscore the need to closely monitor people taking isotretinoin, which is sold as Accutane. Abnormal results for cholesterol and liver function were more common than expected.

Research shows link between acne treatment and depression
The first scientific evidence of a link between a drug for severe acne and depression was unveiled yesterday, following years of denials by the manufacturer that the prescription medicine could be in any way responsible for suicides. Roaccutane has been linked to more than 100 suicides and attempted suicides worldwide.

Acne drug 'linked to depression and suicide'
The new study suggests the drug may disrupt serotonin production in the brain, leading to feelings of despair. Roaccutane (Acutane in the US) has been linked with at least 15 deaths in the UK and more than 200 in the United States, and bereaved parents have previously called for the drug to be taken out of use.


posted by Sepp Hasslberger on Monday January 31 2005
updated on Friday November 16 2007

URL of this article:


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November 15, 2003 - Sepp Hasslberger

In the FDA we trust?
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August 12, 2004 - Sepp Hasslberger

FDA Waffles Over Antidepressants Causing Suicides
According to an article in the New York Times, officials of the FDA are now acknowledging that antidepressants do cause children and teenagers to become suicidal, but the FDA is not taking the steps it should - ban the drugs for use in children, as the UK has already done. The major preoccupation seems to be that if antidepressants are removed or carry strong warnings, there is nothing left to... [read more]
September 15, 2004 - Sepp Hasslberger

Eli Lilly Knew Prozac Causes Suicides, Violence - FDA Closed Both Eyes
Prozac, called fluoxetine by generic name, is a psychiatric drug prescribed to over 50 million people including millions of children. The drug was linked to increased suicides and violence as early as 1988, in a recently emerged document. Apparently the evaluation was known to Prozac's maker Eli Lilly as early as the 'eighties, but was never even given to the FDA. This is the preoccupying picture that emerged just days... [read more]
January 01, 2005 - Sepp Hasslberger

Vioxx Shows: FDA Unable To Protect Public From Deadly Medical Drugs
According to recent congressional testimony, "the FDA as currently configured is incapable of protecting America against another Vioxx. We are virtually defenceless," said David Graham, associate director of the agency's Office of Drug Safety. The quote is from an article published in South Africa, titled Doctor: FDA is too cosy with drug firms. The FDA is the national food and medicines regulatory agency of the US but it has been... [read more]
November 23, 2004 - Sepp Hasslberger




Readers' Comments

It is really scary when many of the most heavily advertised pharmaceuticals, are the same ones that cause the most damage. I would liken it to a year-round hunting season, where these chemical "baits" are offered through the major media, hoping for a "bite" from gullible patients. And it is fed by the sometimes-messianic trust that people often place upon their doctors. But since it is also fed like a cancer with government intervention, we need to remove that from the picture. If the Medicare-Medicaid programs were simply reformed so that patients chose where their dollars went, this could cut out some of the abuses. In the meantime, we just have to work double-time to get out the message that nutrition (and improved lifestyle habits) are the real answers. Since I cured my asthma that way, you can also start miracles in your own life -- and save your loved ones from needless pain and departure.

Posted by: Visionaerie on February 1, 2005 11:28 PM


New (May 2005) development on Accutane, as reported by the Boston Globe, with a comment from Vera Hassner Sharav of the ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)


Posted by: Sepp on May 19, 2005 12:56 PM


its sept 28, 2007, we have a family member in a psych ward right now in new jersey, he is using accutane. hes 16. what and who do i contact for legal advise.


Posted by: darren lopaciuk on September 27, 2007 08:54 AM



try the people at MindFreedom.


contact information:

Posted by: Sepp on September 27, 2007 09:38 AM


My daughter used Accutane in 7th grade for a bad acne problem. Every month, before she was allowed her series of pills, she had to take a pregnancy test. It was a lot of trouble, but it was worth it. Her face became smooth and she has had clear skin ever since that day, minus the small breakouts due to periods. This is a miracle drug and as a high school teacher who sees boys and girls lose all sense of self esteem when their faces look ravaged, I say that with careful supervision, Accutane is the best thing out there.

Posted by: Cordy Reagan on April 23, 2008 12:54 PM


Why do I have a feeling that your are shilling for a pharmaceutical company?

Posted by: Sepp on April 23, 2008 01:36 PM


Beware of toxic medications (Accutane) What is Accutane? Accutane is the brand name for isotretinoin, a drug prescribed for acne which is rapidly being exposed as a public health threat. According to the manufacturer, "Isotretinoin is a retinoid, which …inhibits sebaceous gland function and keratinization. The exact mechanism of action of isotretinoin is unknown.â€?? Accutane usage has been linked to severe psychological disorders and even suicide. Although accounts vary, "More than 200 people have taken their lives while taking Accutane…" Accutane Related Websites: (scroll midway down the page in that website for the info) A voluntary organisation which is run and financed by individuals and families of individuals who have suffered severe side effects from the drug. Created for the Australians that have been injured by the acne medication Roaccutane (Accutane in USA) produced by Roche. The Accutane section of Roche's website (the manufacturer of Accutane.) ACCUTANE Statement of Rep. Bart Stupak October 5, 2000 Dr. Mercola - "Accutane is not the miracle cure-all for acne that it is promoted to be. It causes birth defects in nearly 100 of pregnant women." US Congress Hears Testimony Accutane Link to Depression and Suicide The US Food and Drug Administration (FDA) issued a statement February 24 advising physicians and consumers about reports of "depression, psychosis, and rarely suicidal thoughts and actions" related to use of the acne drug isotretinoin (Accutane). Rep. Burton also blasted the American Academy of Dermatology for not notifying all of its members of Accutane's mental health risks. Accutane also causes severe birth defects.

Posted by: sally on April 29, 2008 08:43 PM


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