The FDA's 'Protection' of the American Public

"Since 1962, people within the FDA itself and outside the agency have complained bitterly that FDA is unduly influenced by drug companies." Jonathan W. Emord, attorney successfully representing litigants against FDA

Courtesy: migraineblog.org

(MYRTLE BEACH, S.C.) - Several years ago, the FDA pulled a dangerous drug off the market after only 5 months called Palladone -- marketed by Purdue Pharma.

Glenn A. Oclassen, Pres. and CEO- Transcept Pharmaceuticals

The FDA needs to protect the American people against another potentially dangerous drug being pushed by Purdue Pharma called Intermezzo. Here is Intermezzo's scary story.

On November 30, Transcept Pharmaceuticals announced that Purdue Pharma (maker of OxyContin) will be launching a new drug called "Intermezzo" in the U.S. with plans to invest $100 million in sales and marketing during the first year.

"We are excited that Purdue will be launching and marketing Intermezzo in the United States," stated Glenn A. Oclassen, President and Chief Executive Officer of Transcept Pharmaceuticals.

"Purdue has one of the most accomplished primary care sales and marketing organizations in the industry. We believe their commercial expertise provides a strong foundation to establish Intermezzo as a successful brand in the insomnia category."

Howard R. Udell, the top lawyer for Purdue Pharma

Mr. Oclassen for you to say that Purdue Pharma's "commercial expertise provides a strong foundation" is as criminal as the charges they pleaded guilty to in 2007 when they admitted they lied about the addictive qualities of their drug, OxyContin. Their actions have unleashed death and addiction throughout the country. Shame on you for making a statement like this about criminals. Ask the Health and Human Services Agency why they took away the rights of Purdue Pharma's three CEO's, Michael Friedman, Paul Goldenheim, MD and Howard Udell, lead counsel to work in the pharmaceutical industry.

Dr. Paul D. Goldenheim, Purdue’s former medical dir.

On November 23, 2011, the "alleged watchdog" for the safety of the American consumer, U.S. Food & Drug Administration (FDA) approved Intermezzo (zolpidem tartrate - Ambien) sublingual tablet C-IV for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Intermezzo is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.

"Intermezzo provides an important new therapeutic option for physicians and patients for the treatment of insomnia characterized by middle-of-the-night awakening," said John H. Stewart, President and Chief Executive Officer of Purdue Pharma L.P. "This decision marks our entry into a new therapeutic area, and underscores the company's commitment to therapeutic advances to address unmet medical needs."

John H. Stewart, is the Pres. and CEO of Oxycontin maker, Purdue Pharma.

Mr. Stewart the only interest your company has in any type of commitment and "unmet medical needs" is to make money and lots of it -- as you did when your dangerous drug, OxyContin was approved by the FDA and unleashed death and addiction in unprecedented proportions throughout the U.S. and Canada.

Purdue will assume responsibility for activities and expense associated with Intermezzo sales and marketing, manufacturing, patent defense, and post-approval studies.

Intermezzo is formulated as a sublingual tablet that contains a bicarbonate-carbonate buffer and is intended to be placed under the tongue where it is allowed to disintegrate completely before swallowing. Intermezzo is to be taken in bed when a patient wakes in the middle of the night and has difficulty returning to sleep.

The recommended dose of Intermezzo for non-elderly patients is 1.75 mg for women and 3.5 mg for men, taken only once per night as needed if a middle-of-the-night awakening is followed by difficulty returning to sleep. The 1.75 mg dose is also recommended for patients over the age of 65.

I wonder if the FDA questionned why Intermezzo is to be taken in bed.  Seems very telling to me.

Citing safety concerns, the FDA had twice previously refused to approve Intermezzo. The FDA had one main worry -- that people might get up and try to drive before the drug fully wears off.  Studies clearly show that the drug badly impairs driving, and that this effect lasts longer in some people than in others.

Responding to FDA concerns, Transcept changed the Intermezzo label to state that the drug should only be taken when people have at least four hours of sleep time remaining. And the label tells people not to drive for at least one hour after waking and at least five hours after taking Intermezzo. Moreover, people should not take Intermezzo if they've been drinking alcohol or if they've taken other sleep aids.

Important Safety Information About Intermezzo

In a driving study, healthy subjects who received Intermezzo with fewer than four hours of bedtime remaining had evidence of impaired driving. The risk of next-day driving impairment (and psychomotor impairment) is increased if Intermezzo is taken with less than 4 hours of bedtime remaining; if higher than recommended dose is taken; if co-administered with other CNS depressants; or co-administered with other drugs that increase the blood levels of zolpidem. A small negative effect on SDLP (standard deviation of lateral position, a measure of driving impairment) may remain in some patients 4 hours after the 1.75 mg dose in women, and after the 3.5 mg dose in men, such that a potential negative effect on driving cannot be completely excluded.

Abnormal thinking and behavior changes have been reported to occur in association with the use of sedative-hypnotics, including decreased inhibition, bizarre behavior, agitation, and depersonalization, as well as visual and auditory hallucinations. Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a sedative hypnotic with amnesia for the event) have been reported in sedative-hypnotic-naïve as well as in sedative-hypnotic-experienced persons. Although behaviors such as "sleep-driving" have occurred with zolpidem alone at therapeutic doses, the co-administration of zolpidem with alcohol and other CNS depressants increases the risk of such behaviors, as does the use of zolpidem at doses exceeding the maximum recommended dose.

Discontinuation of zolpidem should be strongly considered for patients who report a "sleep-driving" episode. The emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation. Other complex behaviors (e.g., preparing and eating food, making phone calls or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with "sleep-driving," patients usually do not remember these events. Amnesia, anxiety and other neuro-psychiatric symptoms may also occur. Patients should not drive or undertake other dangerous activities after taking Intermezzo until they are fully awake. Patients should be cautioned about possible combined effects with CNS-depressant drugs. Intermezzo should not be taken with alcohol.

The potential market of sleep aids to treat middle of the night awakenings is estimated to be worth $1.9 billion to $3.4 billion.

This is what Matthew Edlund MD author of "The Power of Rest" says about Intermezzo --

It's not every day the FDA approves a new drug -- especially a new sleeping pill.  Intermezzo is a term that refers to a separate piece that plays in between acts -- especially for a musical performance like opera. And now it's being repositioned to name a "new" kind of sleeping pill -- one to use in the middle of the night.

Yet Intermezzo is not a new drug and may create more of the problem it's supposed to solve.

What is Intermezzo? Nothing more than smaller doses of the old generic sleeping pill zolpidem (Ambien).  Zolpidem is very popular -- especially among women -- and is famous for provoking bizarre sleepwalking for those who don't immediately jump into bed.

Intermezzo will come out in two doses -- 1.75 mg -- recommended for women -- and 3.5 mg for men. The lowest available dose of zolpidem is 5 mg. People wanting Intermezzo can just get generic zolpidem from their doctors and cut the pills into thirds. Voila -- an old drug has become a new one -- at what will presumably be far less cost.

Assuming the cost of using is worth it.

How Is Intermezzo Meant to Be Used?

Only in the middle of the night for people who cannot get back to sleep and have four or more hours of expected sleep yet to come.

That's a real problem.

One of the banes of insomniacs is clock watching

-- looking at the clock throughout the night.  Most insomnia doctors and researchers will tell you that clock watching is a great way to keep people up all night.

Not only do insomniacs who watch the clock keep themselves awake -- through exasperation they make themselves even more aroused and sleepless. And clock watchers often find themselves waking up in the middle of the night at exactly the same time -- night after night.

They've reset their biological clocks, and caused themselves to wake up.

Behavioral Alternatives

Lots of people wake in the middle of the night -- pretty much close to all of us. Most times we don't know that. Sleep itself causes amnesia, and our awakenings are so short we don't recall them.  But if you do fully wake in the middle of the night there are plenty of alternatives to taking a pill.

Like reading and music.

So if you can't sleep after what you estimate is 5-10 minutes, get out of bed.  Go to a different room or at least a chair -- you don't want to condition yourself to staying in bed if you're not sleeping.

Next, read or listen to music. There are many play lists to help you sleep.  Middle-of-the-night books should prove neither boring nor enthralling. Poetry knocks out many; history works for more than a few, as do travel books, art history, books on music, autobiographies and memoirs. When in doubt, read a book you should have read in high school -- but didn't.

By encouraging clock watching and drug use during the middle of the night, Intermezzo may provoke people to wake in the night in order to take a pill. That may create more chronic insomnia than it will treat.  Low dose zolpidem may work for some, especially shift workers.  But there are plenty of alternatives for middle-of-the-night insomnia before you reach for a sleeping pill -- and they're much safer.

Palladone was pulled from the market

A few years ago, a drug Palladone (Purdue Pharma's next blockbuster narcotic to reap them billions of dollars) was pulled from the market by the FDA after just 5 months. Palladone was a pain relief medication designed for patients who needed moderate to severe pain relief over a 24 hour period. Palladone was a once a day pain medication and operated on what was known as an extended relief system. Palladone was particularly dangerous when taken with alcohol. Alcohol disturbs or even stopped Palladone's extended relief system. In other words, it doesn't work as effectively, causing the patient to take more medication. This is known as dose dumping and with Palladone could have been a serious risk to someone's health.

Being that Palladone was only needed once a day, it caused large amounts to be released into the bloodstream at one time. If this was disrupted and the patient required more, then overdosing was made quite easy.

Palladone was available in various strengths 12, 16, 24, and 32 milligram dosages were prescribed. However, the FDA concluded that dose dumping even at the lowest dosage could produce potentially fatal results. The FDA further acknowledged that all pain relief drugs posed potential dangers if used incorrectly, especially with alcohol. They went on to further say that Palladone was a particular danger due to the high amount of pain medication hitting the bloodstream at one time. The symptoms could range from shortness of breath to death.

Purdue Pahrma, the creators of Palladone did place warnings on the package informing users about the dangers when mixed with alcohol. However, the FDA stated that the risk was still too great and label warnings were not enough to guarantee safety because of how the drug works.

I emailed and faxed members of Congress and Attorney Generals of the dangers of Palladone. I will be emailing and faxing members of Congress and Attorney Generals of the dangers of Intermezzo. The FDA acted responsibly several years ago in pulling Palladone off the market. They need to act responsibly again with Intermezzo and ask -- Would they feel safe knowing the driver commuting to work next to them, or a family member, may have ingested an Intermezzo 4 hours prior to getting behind the wheel of a car and worse possibly not even knowing they were behind the wheel of the car?

The FDA owes the American people a responsibility to save lives and pull Intermezzo off the market before it is too late. The FDA cannot use the Michael Jackson mentality -- Sleep at any cost, even if it results in death.

LP - For the best 16 months of our lives, I award you love, peace, faith and laughter -- and I'll throw in the popcorn too! Told you it would never be boring.

Marianne is a nurse having graduated in 1991 as president of her graduating class. She also has a Paralegal certification. Marianne served on a Community Service Board for the Courier News, a Gannet newspaper in NJ writing articles predominantly regarding AIDS patients and their emotional issues. She was awarded a Community Service Award in 1993 by the Hunterdon County, NJ HIV/AIDS Task Force in recognition of and appreciation for the donated time, energy and love in facilitating a Support Group for persons with HIV/AIDS.

Marianne Skolek
National Activist for Victims of OxyContin and
Purdue Pharma - a criminally convicted pharmaceutical company
Staff Writer, Salem-News.com www.purduepharma.com/pressroom/app/news_announc/USGovt_reponse_Main.pdf

judiciary.senate.gov/hearings/testimony.cfm?id=2905&wit_id=6612

i.bnet.com/blogs/sebelius-response.pdf

www.vawd.uscourts.gov/PurdueFrederickCo/default.asp

www.oxydeaths.com