The Bitter Pill

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Roche Puts Accutane Profits Over Lives of Consumers

Evelyn Pringle August 31, 2006

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.

On November 14, 2004, BBC News reported that Jon Medland, 22, in the final year of medical school at Manchester University, hanged himself at his student lodgings on January 13, 2004 while on Accutane.

When questioned about the incident, Roche told BBC News that the drug carried a warning of possible mood changes and depression, but said “no causal link had been established between the drug and either depression or suicide.”

Less than a year later, in September 2005, BBC News reported that David Roberts, 21, had been on the drug for two months when he hanged himself near his Liverpool home.

And once again, according to BBC News, “Roche insists there is no proven relationship between the drug and depression.”

However, David’s father, Fred Roberts, said he could think of no other explanation for the tragedy. “David was the most happy-go-lucky, carefree lad you could ever hope to meet. He had plenty of friends, he enjoyed going out, he had a happy family life.”

“His acne wasn’t severe at all. He had a few spots and, like any young person, he wanted to get rid of them.”

“The change in him was so sudden,” Mr Roberts said, “there’s no other reason for it than the effect of this drug.”

On January 15, 2006, 15-year-old Justin Zimmer, of Menasha, Wisconsin, shot himself and his parents blame Accutane.

Justin’s parents and a friend told the Appleton Post Crescent on July 18, 2006, that he gave no indication that he was depressed and that he was all excited about getting his driver’s license in a couple of weeks.

Roche’s comments to the BBC are clearly dishonest considering that in 1986, doctors were notified that Accutane users who became depressed saw their depression lift when they stopped taking the drug but return when they were placed back on the medication. Doctors were also informed that simply stopping Accutane therapy might not be sufficient to treat the depression and that follow up on the depression might be necessary.

In 1998, the FDA notified doctors that Accutane, “may cause depression, psychosis, and rarely, suicidal ideation, suicide attempts and suicide.”

The agency issued a MedWatch alert in February 1998, that said due to the adverse event reports received, the FDA felt there was sufficient cause to strengthen the warning on the Accutane label to include the risk of psychosis and suicidal thoughts and actions.

The February 23, 1998, FDA Memorandum, “Isotretinoin and Depression: Spontaneous Report Data,” listed 31 cases of suicide, suicide attempt or suicide ideation associated with Accutane. Of those cases, 12 were suicides, 9 were male, 2 were female, and 1 unknown, and the average age was 17. The event occurred on average, 88 days after the patient started taking the drug.

The FDA acknowledged in the memorandum that for “the majority, there was no antecedent history of depression and the patients were not noted or known to be depressed in the time period prior to their suicide.”

During a US House Oversight and Investigation Subcommittee hearing on the Safety Issues Relating to Accutane, on December 11, 2002, internal documents from the nation’s regulatory agencies were entered into the record that revealed that public health officials had been voicing concerns about patients committing suicide while on Accutane for well over a decade.

For instance, a 1998 memo from the FDA’s medical officer in charge of Accutane states: “Given all the pieces of evidence available, it is difficult to avoid the conclusion that Accutane can adversely affect the adult human brain in clinically significant ways and that Accutane use is associated with severe psychiatric disease in some patients.”

The memo recommends “active consideration of removal of Accutane from the market.”

But instead of removing the drug from the market, on February 25, 1998, the FDA required Roche to add the following bold-face warning to drug’s physician package insert:

“WARNINGS – Psychiatric Disorders: Accutane may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide. Discontinuation of Accutane therapy may be insufficient; further evaluation may be necessary. No mechanism of action has been established for these events.”

“ADVERSE REACTIONS – In the postmarketing period, a number of patients treated with Accutane have reported depression, psychosis and rarely, suicidal, ideation, suicide attempts and suicide. Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy.”

In perverse twist of logic, in the same year, Roche began actively marketing Accutane as a treatment for depression, under the theory that it could help people who were suffering from depression due to poor self-image as a result of acne.

On March 5, 1998, Roche received a letter from the FDA stating that such promotion was false and misleading, and that Accutane had never been approved for the treatment of depression, and that in fact, just the opposite was true. The letter stated in relevant part:

“Roche … has not systematically studied the ability of Accutane to modify or prevent such illnesses as depression and has presented no basis for asserting that Accutane is effective in improving the psychosocial and emotional well-being of such patients.

“This claim is particularly troublesome in light of information recently presented in a Dear Doctor letter, that Accutane may cause depression, psychosis, and rarely, suicidal ideation, suicide attempts and suicide.”

The FDA also instructed Roche to “prominently disclose information about the psychiatric disorders described in the warnings section of the revised labeling” in Accutane advertisements.

In September 1998, the FDA presented an Advisory Panel with 37 cases of suicide attributed to Accutane since 1983. However, the number was later changed to 44 suicides after Roche corrected its calculations.

The Adverse Event Reporting System (AERS) is a computerized database of post-marketing adverse events, designed to support the FDA’s post-marketing surveillance program of all approved drugs.

The reports in AERS are evaluated by agency reviewers in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to detect safety signals and to monitor drug safety.

The results of a review of AERS by congressional staffers working on behalf of Congressman, Bart Stupak (D-MI), revealed during an October 5, 2000, hearing, reported 54 more suicides by persons on Accutane after the FDA issued its MedWatch in 1998.

In 2004, the Alliance for Human Research Protection, asked Keith Altman, an Adverse Drug Reaction Statistics Analyst, to analyze the FDA’s Medwatch database for drug-linked suicides by children under the age of 18. The analysis found that between 1989 and June 2003, there were 216 reports of drug-linked suicides, and 72 were associated with Accutane.

The Alliance points out that MedWatch reflects approximately 1% of actual adverse events, so 72 Accutane suicide reports could represent as many as 7,200 suicides.

Congressman Bart Stupak, lost his son, BJ, to suicide on Mother’s Day, May 14, 2000, at the age of 17, from a self-inflicted gunshot wound and BJ was on Accutane at the time of his death.

On December 11, 2002, Rep Stupak told the audience at the Safety Issues Surrounding Accutane Hearing that, “Anyone who knew BJ could not understand why a young man with such an outgoing personality and bright future would end his own life.”

“BJ taking his own life,” Rep Stupak said, “is contrary to everything he believed in!”

After his suicide, BJ’s mother, Laurie, checked out Accutane on the Internet and found many adverse events associated with the drug that they was never told about.

But the most disturbing find she said, was the February 1998 MedWatch stating, “The FDA is advising consumers and health care providers of new safety information regarding the prescription anti-acne drug Accutane (isotretinoin) and isolated reports of depression, psychosis, and rarely suicidal thoughts and actions.”

“After we found the MedWatch,” Rep Stupak said, “I wondered why the FDA put out this warning, 18 years after the drug was approved?”

“More important,” he continued, “why weren’t these warnings on BJ’s Accutane package which had been revised 4 months after the MedWatch was issued?”

Two other couples testified at the hearing about their sons who had no history of depression, but yet committed suicide while taking Accutane. The spontaneity of the suicides became the center piece of discussion between committee members and witnesses during the hearing.

Susan and Martin Turney from Watertown, New York testified about their 16-year-old son, Matthew, who took his own life on March 14, 2001, and was on Accutane at the time of his death.

In retracing the days leading up to Matt’s death, nothing indicated that anything was wrong. The night before the suicide, everything was normal his parents recalled. The family had a nice dinner together, talked about the day’s events and joked and laughed with each other like always.

The next morning, Matt got up for school as usual. Before leaving to catch the bus, he looked at his father, smiled and said “Good Bye,” and yelled, “Good Bye Mom. I love you,” to his mother who was in another room, just like he did every morning.

By all accounts, Matt was fine at school that day. He talked to his guidance counselor about a program she had recommended for the next year. He asked a girl to a dance and she agreed to go. He took a couple of tests and did well.

On the bus ride home, Matt sat with his friends and laughed and fooled around just like any other day. He got off the bus and stopped to pick up the newspaper and mail as usual. He took off his shoes in the entryway, placed the mail and newspaper on the kitchen counter as he always did, and went into his room and hung up his coat.

His parents say it is at this point that Matt’s normal routine changed. He did not turn on the TV, or get a snack or check his email as usual. Instead, he apparently went into the master bedroom, unlocked the gun case, took out a gun and shot himself.

His father came home from work and yelled “Hello” to Matt, but got no response so he went looking for him and found Matt on the floor of the bedroom with no heartbeat.

While answering questions from police at the hospital, Matt’s parents were asked if Matt was taking any medication and they said Accutane. As soon as they answered, they remembered a TV Dateline program about the parents whose son committed suicide while on Accutane.

After watching the program Matt and his mother had went to the Dermatologist to discuss the story and their concerns about Accutane. The Dermatologist said that there had been a couple of unsubstantiated cases of depression and suicide, but that there was no scientific proof that Accutane could cause it and that Matt “didn’t fit the profile anyway.”

Matt’s parents told the committee how they later found out that Accutane was supposed to be reserved for the most severe cases of nodular, cystic acne and provided the panel with a school picture of their son taken about 2 weeks before he started on Accutane that showed he did not have a severe acne problem.

“After talking to all of Matt’s friends, family, teachers, and co-workers,” his father told the committee, “we confirmed what we had already known, Matthew was not depressed!”

“His sudden death came as a shock to every person who knew Matt, including us, his parents,” he said. Matt’s suicide was “spontaneous,” his parents said:

“There was no depression. There was no warning. There was nothing for us to look for. There was no reason for his death, other than Accutane.”

Michael and Caroline Bencz also testified at the hearing about how their son, James, committed suicide without any sign that he was depressed or troubled. They told the panel that at the time of his death, he had everything to live for stating:

“James was not the person anyone would expect to commit suicide. He had friends and family. He had financial and personal success. He had plans for the future – both near and long term.

“The week James died, he was to leave on a skiing trip to Austria with a few of his firefighter buddies. James had plans for his future, and death was not in that plan.”

“He was witty, humorous, talented, a great sportsman, intelligent, and highly competitive,” his parent said, “but most of all, above all that, a wonderful human being.

In late 2001, they told the panel, they learned that a doctor prescribed Accutane for James. These parents also provided the committee with a picture of their to show that he never had a severe acne problem. All they could figure out was that maybe the skin diving suit he wore may have irritated his skin on his neck and back.

The last day they heard from James, on February 23, 2002, he called to say he did not feel well, that he had a headache. His last words to his parents were: “I don’t feel too good, I’m going to try to get some sleep.”

Over the next few days they did not hear from James which was very unusual. It was not like him, his parents said, to disappear for days at a time without letting anyone know where he was.

When he did not turn up, a massive man hunt was conducted, and he was eventually found on March 4, 2002, at the bottom of a lake, with a 44 pound barbell strapped to his body. A lake where James and his sister used to sit as children skipping rocks.

He died, his father told the committee, “under circumstances so bizarre for someone like James – a diver, a firefighter, and an athlete – with so much to live for, and so many future plans.”

“We wish every minute of every day that we had never heard of that drug,” they told the committee. “It took our son, our life as we know it, and left us with huge craters in our hearts that can never be filled in again.”

These reports of inexplicable suicides were alarming to members of the committee. “Is it possible that this medication has an effect, an action that results in spontaneous, impulsive, self destructive behavior that is different from that which occurs from a clinical depression?,” Congressman Ted Strickland (D-OH), who has a PhD in psychology, asked.

“I know of no clinical concept of depression that has an instantaneous onset and what we’ve heard described are people who are emotionally,” Rep Strickland said, “psychologically healthy with none of the clinical signs of depression spontaneously doing something to themselves.”

“So I’m wondering,” he concluded, “if we are dealing here with something other than depression, and that we ought to recognize that.”

The FDA Office of Drug Safety keeps a monthly cumulative count of psychiatric adverse event reports in AERS. According to Dr Janet Woodcock, Director of the Center for Drug Evaluation and Research, at the hearing, as of November 30, 2002, AERS contained 3,104 reports with at least one reported psychiatric event.

The FDA is aware of 173 reports of suicide in association with Accutane, she told the panel. She noted that the FDA had requested quarterly summaries of psychiatric events from Roche and said the most recent summary through August 2002 indicated approximately 6,000 additional reports that include psychiatric events

Because the 173 cases of suicides ware based on self reporting, experts say that figure is highly suspect and that being as few as 1% of suicides are reported as adverse events, it could mean that the actual number of suicides may be as high as 17,000.

During his December 11, 2002 statement to the committee, Congressman Stupak pointed the finger of blame directly at the FDA when stating:

“Accutane is a powerful, dangerous drug with devastating consequences for some patients. The birth defects caused by Accutane are horrific. The FDA’s response to the birth defects and psychiatric events has been inadequate, irresponsible and unacceptable. Thousands of babies, teenagers, and young adults have died prematurely.

“While the FDA has been aware of the birth defects since at least 1982 and the psychiatric injuries since 1985, their responsibility to protect the public has been inconsistent and without direction.”

There is no debate about whether Accutane is a moneymaker. According to the Associated Press on August 21, 2006, patients usually take it for up to a year at a cost of $10 to $15 per day. And in the December 11, 2002 hearing, Congressman Stupak turned the attention of the committee to Roche’s conduct of putting profits before people and stated:

“They have done everything possible to prevent the American people from learning of the psychiatric injuries and deaths associated with Accutane. Even, today … Roche will deny any casual effect of Accutane with the abortions, deaths, and suicides caused by their product.”

“We cannot allow the drug manufacturer and the FDA to continue to turn a blind eye to the lives lost, families devastated and dreams dashed by an acne drug,” he said.

“The American people, our children,” he said, “are not collateral damage in the scheme of corporate profits!”

Filed under: 2006, Accutane, Birth Defects, Hoffman-LaRoche, prices, suicide

Accutane still a Top Seller for Hoffman-LaRoche

Evelyn Pringle August 25, 2006

Accutane, manufactured by Hoffman-LaRoche, was FDA approved in 1982, only to treat the most severe form of acne. Yet by 1998, the medication was the company’s second-largest-selling drug, with about $800 million in sales.

Accutane (Isotretinoin) entered the market in the US in 1982, and has been at the center of one firestorm after another ever since. It was never intended to treat a large number of patients. The FDA approved the drug for the treatment of severe nodular cystic acne, a type of acne that is painful, disfiguring, and will not respond to other forms of treatment.

The FDA approved labeling specifically points out that the drug is not to be considered a treatment of first choice:

“Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.”

The original labeling issued in 1982, designated the drug as Category X, meaning it was to be avoided by all pregnant women. Yet by 1983, babies were being born with birth defects to mothers who used the drug during pregnancy.

Alarmed by these reports, in September 1983, the non-profit consumer advocacy group, Public Citizen, submitted a petition to the FDA requesting patient package inserts and a black box warning label be added to Accutane describing the risk of birth defects and mental retardation.

Looking back, Public Citizen has been warning the FDA about the risks of serious harm to fetuses exposed to Accutane for more than 20 years. In 1984 the group sent a letter to the FDA advocating for improved pregnancy surveillance and lower dosing regimens.

During an FDA Advisory Committee meeting in 1988, the group described isotretinoin as an imminent public health hazard and urged the panel to remove the drug from the market unless tighter and effective restrictions were implemented.

The next year the group testified again and asked the FDA to withdraw isotretinoin from the market unless the previously proposed restrictions were adopted immediately.

In 1989, the CDC testified before an FDA Advisory Committee, and stated that the birth of babies with defects caused by fetal exposure to Accutane was unnecessary and called the FDA’s decision to allow the marketing of Accutane, a “failed regulatory experiment.”

At a December 11, 2002 House Oversight and Investigation Subcommittee hearing on the Safety Issues Relating to Accutane, internal documents from the nation’s regulatory agencies were placed in the record that showed public health officials had been expressing serious concerns about Accutane and birth defects for well over a decade.

For instance, a 1990 internal FDA memo stated, “Accutane poses an imminent hazard to public health, and as such should be withdrawn immediately from the market.”

A 1990 report by the FDA said, “The magnitude of fetal injury and death has been great and permanent, with 11,000 to 13,000 Accutane-related abortions and 900 to 1,100 Accutane birth defects.”

In August 1997, the FDA issued a warning letter to Roche for failing to submit serious adverse event reports in a timely manner and Roche claimed its computer systems were responsible for delays of up to eight years in complying with the law.

A February 1998 FDA memo stated that Roche “had not acted in good faith to truly and accurately answer questions relating to Accutane use in women and pregnancy exposure.”

The memo goes on to recommend “active consideration of removal of Accutane from the market.”

A 1998 letter to the FDA from an official at the Centers For Disease Control compared Accutane to the infamous cancer and leprosy drug, Thalidomide, known for causing of birth defects, and stated, “we simply need to remove the drug from the market.”

In response to calls for the withdrawal of Accutane, Roche proposed a patient education program on the risk of birth defects, that included patient materials and informed consent forms for women to sign before receiving the drug.

In September, 2000, because the number of prescriptions to women of child-bearing age had tripled from 70,000 a year in 1989, to almost 210,000 in 1999, there was more concern over the increasing number of pregnant women exposed to the drug so FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee held a meeting to discuss what measures might help prevent further fetal exposure.

Public Citizen once again testified at the hearing and recommended that a Patient Medication Guide be issued and again urged the FDA to remove Accutane from the market unless restrictions were implemented and proven to be effective.

As a result of recommendations made by the Advisory Committee following the hearing, Roche agreed to develop a program designed to prevent pregnancies in women using Accutane.

The “System to Manage Accutane Related Teratogenicity,” or SMART program, was implemented in April 2002, and required women to have 2 pregnancy tests before starting on Accutane, to get a pregnancy test each month before refilling a prescription, to receive counseling on birth control, and to agree to use two forms of birth control simultaneously while using Accutane.

The Adverse Event Reporting System (AERS) is a computerized database of post-marketing adverse events for all approved drugs, designed to support the FDA’s post-marketing safety surveillance program.

The reports in AERS are evaluated by agency reviewers in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to detect safety signals and to monitor drug safety.

During the December 11, 2002 hearing, Roche claimed that only 2,300 pregnancies had occurred among Accutane users since its introduction in 1982. However, Congressman Bart Stupak (D-MI), refuted that assertion, by citing a 1999 company report indicating that in a single 3 month period that year, 93 unwanted pregnancies were reported and 42 abortions occurred.

According to Dr Janet Woodcock, Director of the CDER at the hearing, AERS contained almost 23,000 adverse event reports for Accutane from the time of its approval in 1982 to December 2002.

For 2002 thus far, she said, AERS contains just over 1,100 adverse event reports. During 2002, she told the panel, the five most frequently reported reactions are, in descending order, depression, pregnancy, induced abortion, suicidal ideation, and headache.

Dr Woodcock explained that the Office of Drug Safety (ODS) within CDER maintains a quarterly cumulative count of reports of Accutane-exposed pregnancies and outcome, if known, based on Roche’s quarterly submission.

The latest update as of June 2002, she said, “shows a total of 2,350 Accutane-exposed pregnancies and 172 babies born with a congenital defect or anomaly in the U.S. since the product was approved in 1982.”

According to testimony by Dr Nancy Green, medical director of the March of Dimes Birth Defects Foundation, Associate Professor of Pediatrics and Cell Biology at the Albert Einstein College of Medicine, the major birth defects include a syndrome that includes mental retardation, hydrocephalus, microcephaly, cleft lip and palate, cardiovascular anomalies, and ear and limb abnormalities.

Lynn Martinez, Manager of the Organization of Teratology Information Services (OTIS), a national group that tracks prenatal birth defects exposure, informed the committee that OTIS was still receiving reports from women who had become pregnant while taking Accutane, despite the SMART program.

To measure compliance with the SMART program, researchers surveyed 34 women who had called a member service of the OTIS between April 2002 and September 2004 because they had become pregnant while taking isotretinoin.

The survey revealed that only 24% of the women received contraception counseling and while SMART required women to use two forms of birth control simultaneously while taking Accutane, only 62% of the women reported using any birth control and only 29% of those women reported using two forms.

According to the rules, women were required to have two negative pregnancy tests before receiving a prescription, but 76% said they did not have a second pregnancy test

When asked about the requirement of receiving a pregnancy test each month before refilling a prescription, 35% of the women surveyed said they did not have monthly pregnancy tests.

In addition, only 53% of the women reported signing the informed consent required by SMART prior to taking the drug.

Julia Robertson, coordinator of the Birth Defects and Genetics Program at the Utah Department of Health in Salt Lake City, and lead author of the study, said the failure to avoid pregnancy had resulted in a high rate of abortions and at least one baby born with severe birth defects.

The survey confirmed that the SMART program was not being followed by women or doctors, mainly because the program was not mandatory. The results of the study appeared online on October 14, 2005, in the journal Birth Defects Research (Part A): Clinical and Molecular Teratology.

The survey also revealed that the majority of women were prescribed Accutane off-label for less severe acne than is recommended by the SMART program.

At the December 11, 2002, hearing, the subcommittee discussed the problem of “off-label” prescribing to patients without severe cystic acne and some experts estimated it to be as high as 90% among women.

During the hearing, Roche’s North American president and CEO, George Abercrombie, denied promoting Accutane for patients not suffering from severe acne. When confronted with print advertisements that featured teenage models with little or no visible acne, Mr Abercrombie pointed out that the ads did not specifically mention Accutane and said they were intended to make consumers aware that there were treatments for severe acne.

That statement went over like a lead balloon. “What you just said is not a truthful statement,” Congressman Peter Deutsch (D-FL), told him. “You’re beyond the straight-face test, I’m sorry.”

Due to the failure of the SMART program, and the continuation of babies born with birth defects, in March 2006, the FDA implemented the iPledge program, which basically follows the same rules as the SMART program, but doctors and patients are no longer on the honor system.

IPledge requires a woman to have two pregnancy tests before the initial prescription for Accutane is written, and to have a monthly pregnancy testing before each refill. But now, the prescribing doctor is required to register the test results in the computerized iPledge system, and the woman must fill her prescription within seven days.

In addition, the woman must agree to use two forms of birth control while using the drug and she must also register with the iPledge system to certify that she is using two forms of contraception.

It could be said that Roche has between 300 and 450 good reasons to keep selling Accutane off-label to as many women as possible each month, because according to an August 21, 2006 article by the Associated Press, the daily pill costs between $10 to $15 a pop.

Filed under: 2006, Accutane, Birth Defects, FDA, FDA hearing, Hoffman-LaRoche, prices, suicide

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