Generic drugs are not exactly like brand names

Gianna at Bipolar Blast stumbled upon an article at the LA Times that outlines the FDA’s standard for generics:

In almost all cases, the FDA permits a generic drug to release 80% to
125% of an active ingredient into the bloodstream, compared to that
released in a single dose of the original medication.

Gianna makes a good point for tapering down on brand-name meds then switching to generics:

And definately too broad when I’ve been cutting down my only 10% at a
time. If the drug is 80% of what I’m taking that is a 20% cut without
intending a reduction. It of course can work the other way and make
coming off the drug a longer task and more difficult if it’s actually
125% of the brand name.

eek – that’s something to think about.

Loose Screws Mental Health News

I recently wrote about the MOTHERS Act and the unnecessary scare tactics surrounding it. A Dallas-Fort Worth TV station picked up on the story and provided a short one-sided view of the issue, continuing to purport that the bill is solely about drugging new moms. I don’t discount Ms. Philo’s terrible experience with her medication. In fact, I’d be against the act if its sole purpose was to force treatment on pregnant women – medicated or not. Again, I’d like to reiterate that the bill’s purpose is to educate moms about postpartum depression and postpartum psychosis – not to shove unnecessary pills down women’s throats.

If you have sleep apnea, your CPAP (Continuous Positive Airway Pressure) machine may alleviate depression symptoms. My husband has sleep apnea and hasn’t been able to use the CPAP machine because of sinus problems. When he doesn’t use it (he hasn’t for a while), he’s noticeably moodier and prone to depressive symptoms. But then again, anyone who doesn’t get good sleep for several days is pretty moody.

Seroquel XRAstraZeneca (AZ) is going after Teva Pharmaceutical Industries and Novartis AG’s Sandoz unit after the two companies applied to make cheaper version of Seroquel available. AZ’s patent on Seroquel expires in 2011. The trial date for patent litigation is August 11. In the meantime, according to the Bloomberg report, the FDA is considering approval of Seroquel XR for bipolar depression and bipolar mania.

What is it about the U.K. that they seem to take pharma’s power more seriously than the U.S.? The UK Medicines and Healthcare products Regulatory Agency (MHRA) charged GlaxoSmithKline (GSK), the maker of Seroxat (Paxil in the U.S.), with not fully disclosing their clinical trial data that downplayed serious side effects such as increasing suicidal tendencies among those 18 years and younger. The MHRA also asserts that Seroxat didn’t alleviate depression as much as GSK’s initial data showed. GSK, of course, denied manipulating the data to show favorable results:

GSK denies withholding data, claiming the risks did not come to light until the results of nine studies were pooled.

The UK minister of public health, Dawn Primarilo, promised to address the issue of Big Pharma hiding negative clinical trial data.

“Notwithstanding the limitations that may exist in the law, pharmaceutical companies should disclose any information they have that would have a bearing on the protection of health,” she says.

In other news, I shouldn’t be a successful writer or novelist. The correlation between creative writers and suicide is ridiculously high. More than 70 well-known writers and poets have successfully committed suicide. How much more “unknown” writers and poets have as well?

(Image from Monthly Prescribing Reference)

I hate to brag, but…

I hate to brag, but…

February 28, 2007
Pristiq's FDA Chances: Depression – Yea; Menopause – Nay

It wouldn't surprise me if they said yea to antidepressant use and nay to vasomotor use because of lack of evidence in improved symptoms.

April 19, 2007
Wyeth looking for Pristiq's FDA approval in 2008

I'll follow Pristiq as the information continues to trickle out but don't expect to hear much about it until next year when Wyeth becomes the proud papa of a brand new (and approved) product.

This is one of the few times I can actually say I was right. (Teenage-like "squee!" goes here.)

More recent posts from:

Loose Screws Mental Health News

Let’s start off small and build up, shall we?

A blog I came upon, Providentia, has a post on the suicide rate in Kentucky over a 10-year period. Male schizophrenics have the highest rate of suicide. The leading methods of suicide in the state are firearm use, overdose, and hanging.


Mary WinklerMary Winkler, the preacher’s wife who killed her husband, has been moved from jail to a mental health facility, where she will serve the remainder of her three-year sentence.


East meadow, a poster on the drugs.com message board, asks about Lexapro’s correlation to suicide. Her sister committed suicide while on Lexapro and questions whether the Lexapro might have affected her in that way. As a former Lexapro user, I can empathize with the change in her sister’s behavior.


The Depression Calculator: see how much depression is costing your company and see if treatment is worth your while. I went through it for kicks and basically, I walked away feeling like it cost too much to hire someone with depression, especially if I were running a small business. Blah.


Apparently, bipolar disorder is covered under the Americans with Disabilities Act (ADA). Starbucks is settling an $85,000 lawsuit with Christine Drake, a former Starbucks employee who suffers from bipolar disorder. It seems that Drake’s first manager was willing to work with her “psychiatric impairment” and allow her to gain “extra training and support.” Then, get this:

“But, during her third year, new management told her she was “not Starbucks material,” refused to continue the accommodation and ultimately fired her for discriminatory reasons, the agency alleged.”

Starbucks probably put up one helluva fight, but in the end, they’ve tried to put a good face and good spin on the situation:

Starbucks agreed to pay Drake $75,000 and donate another $10,000 to the Disability Rights Legal Center, which provides legal representation for low-income people with disabilities facing discrimination, as part of the settlement.

“The facts of this case illustrate how relatively minor accommodations are often all that disabled people need to be productive members of the work force,” said the EEOC’s San Francisco district office director, Joan Ehrlich. “It is important that all of Starbucks’ managers understand their legal duties regarding disabled employees and provide them with the tools necessary to succeed. This is in everyone’s best interest.”

Ms. Drake, who seems to be more than capable of handling a job well, has probably eeked out several years of a barista’s salary from the Starbucks suit.


I’m amused, but it’s not necessarily a good thing.

RisperdalJohnson & Johnson is gearing up to put Risperdal for children on the market. I’m sure other blogs have beat me to the punch on this, but I just came across this info and found it absolutely retarded. (But what do drug companies care?)

The FDA has approved “expanded use” for Risperdal in teenagers who suffer from schizophrenia and the short-term treatment of bipolar mania in kids ages 10-17. I’m leery enough about antidepressants in kids let alone antipsychotics.

“J&J said the agency has not requested the company perform any additional studies, implying that it need only agree with the FDA on acceptable labeling for the expanded uses in order to gain final approval.”

I wasn’t sure what “expanded use” was so I looked it up. This was the best I could come up with:

“Applications for a new or expanded use, often representing important new treatment options, are formally called “efficacy supplements” to the original new drug application.”

Well, I didn’t know what efficacy supplements were so I looked that up too:

“The legislative history indicates that this provision was directed at certain types of efficacy supplements (i.e., supplemental applications proposing to add a new use of an approved drug to the product labeling).”

So – correct me if I’m wrong – it sounds like the studies performed that led up to this “expanded use” are not as rigorously evaluated by the FDA as the initial studies that allowed the drug to be released on the market in the first place. It just seems like a company and the FDA simply need to agree on “acceptable labeling.” So if we’re following the theory that I’m still correct, the FDA doesn’t follow up on the clinical trials performed on these children, they just agree with J&J on the “acceptable labeling.” Doesn’t that thought make you feel all warm and fuzzy inside about your health?


Christopher PittmanOn the subject of children and psychotropic medications, 12-year-old Christopher Pittman shot and killed his grandparents and then set their house on fire in November 2001 all while on an adult dosage of Zoloft. It looks like the drama is still playing out in June 2007.

According to CourtTV.com, Pittman suffered from hallucinations while on the 200 mg dose and while in jail, displayed symptoms of mania.

“Three years after the killings, Pittman was tried in adult court and convicted of murder. He was sentenced to 30 years in prison. He was then 15 years of age.”

No doubt Pittman should be held responsible for what occurred, especially if he admitted to the killings (which he did). However, the situation raises a few questions. First of all, why was he on 200 mg of Zoloft when he was TWELVE? Why wasn’t he considered mentally ill and placed in a mental health facility? I could go on and on. While Pittman “did the crime and needs to do the time,” why isn’t the doctor who prescribed this not present in any of the reported stories? If this incident was 2001, it can only be worse for antidepressants and other psych meds today.

Women & Antidepressants

Pink, a magazine for business women, has an article in its April/May 2007 issue titled, “The Magic Pill.” (The only way to read this article is to get a hard-copy of the mag.) No, this isn’t about birth control. The subhead: “Antidepressants are now used for everything from migraines to menopause. But are women getting an overdose?”

Good question. The article, well-written by Mary Anne Dunkin, does a nice job of trying to present both sides of the coin. One subject, Pam Gilchrist, takes tricyclic antidepressants to relieve her fibromyalgia symptoms. “One of the [antidepressants] that allows her to keep going” is Effexor (venlafaxine). God forbid the woman should ever have to come off of that one. (It works well when you’re on it, but withdrawal is sheer hell.)

The other subject mentioned in the article, Billie Wickstrom, suffers from bipolar disorder, but had a therapist who diagnosed her with obsessive-compulsive disorder. The psychiatrist she was referred to promptly put her on Anafranil (clomipramine). We all know what antidepressants tend to do for those with bipolar disorder. Wickstrom blanked out at an interview that she says she normally would have aced. In another incident, she veered off-course after leaving town and spent the night on the side of the road with her daughter. “Search parties in three states” were out looking for them.

“Three years and three hospitalizations later, Wickstrom is finally free of clomipramine and has a job she loves as PR director for a $300 million family of companies. She says she’s happy, she’s focused and she feels great – consistently.”

Dunkin’s article uncovers a large, problematic use – by my standards, anyway – of off-label usage by doctors.

“Gilchrist… is one of the estimated one in 10 American women taking some type of antidepressant medication. And a considerable percentage of these prescriptions, particularly those for tricyclic antidepressants, are not used to treat depression at all.

A growing number of doctors today prescribe antidepressants for a wide range of problems, including anxiety, chronic pain, insomnia, migraines, high blood pressure, irritable bowel syndrome, premenstrual syndrome, menopausal hot flashes and smoking cessation.”

I’m sure the list goes on, but magazines have but oh so much space.

Melissa McNeilDr. Melissa McNeil at the University of Pittsburgh points out three things:

  1. Since depression is a prevalent (see common) condition, doctors are better detecting it.
  2. Since antidepressants have proven their safety and efficacy, primary care physicians have no reservations prescribing them.
  3. Clinical studies are finding that antidepressants can aid a number of medical issues apart from depression.

My take on McNeil’s points (I’ll try to keep them brief):

  • Depression is way too common to be abnormal. If a woman has a rough patch in life for 2 weeks or more, she’s got depression. As for doctors being better at detecting depression? Studies consistently show that doctors are great at overlooking depression in men.
  • Antidepressants haven’t proven jack squat. Placebos have proven more safety and efficacy than antidepressants. PCPs have no reservations prescribing them because they only know about the positive facts that pharma reps tell them instead of researching the potential side effects.
  • Clinical studies aren’t finding all those things out. Seroquel has FDA-approval to treat psychiatric symptoms (psychosis, for one). As far as I know, Seroquel is not FDA-approved to treat insomnia or crappy sleeping patterns. There are no specific clinical studies to see if Seroquel can treat insomnia. Seroquel is prescribed to treat insomnia/restless sleep because doctors have found that a major side effect of the drug is somnolence. If this is the case, Effexor should be prescribed for weight loss. It’d be the new Fen-Phen.

Dunkin cites two widely used antidepressants for nonpsychiatric uses: Wellbutrin (bupropion) and Prozac (fluoxetine). Zyban, used for smoking cessation is, well, bupropion. Sarafem, used to treat PMS symptoms is – you guessed it – fluoxetine.

Viktor BouquetteDr. Viktor Bouquette of Progressive Medical Group thankfully takes a more cautious approach:

“The widespread use – mostly misuse – by physicians of antidepressants to treat women for far-ranging symptoms from insomnia, chronic fatigue and irritability to PMS and menopause is merely another unfortunate example of the pharmaceutical industry’s tremendous influence on the practice of modern medicine. Take enough antidepressants and you may likely still have the symptoms, but you won’t care.”

Kudos to Dunkin for landing that quote. Since Bouquette is part of an alternative medicine group, he’s got a good motive for slamming pharma companies.

McNeil goes on to sound anti-d happy in the article. Not that it matters, but she is also a section editor for the Journal of Women’s Health, which has several corporate associates representing pharmaceutical companies. (She is also the only source in the article who sings anti-d’s praises.) Dunkin tracked down Dr. Scott Haltzman, a clinical professor at the Brown University Department of Psychiatry, who advocated patient responsibility.

“Just because antidepressants work for depression does not mean they should always be used. People need to learn skills to manage their depressive symptoms instead of depending on medication. When you take medicine for every complaint, you lose the opportunity to learn how to regulate your mood on your own.”

Oh, for more doctors like Haltzman and Bouquette.

UPDATE: Uh, alleged fraud suit pending against Progressive Medical Group. Bouquette is now part of Progressive Medical Centers of America.

Loose Screws Mental Health News

In one of the scariest articles I’ve read in a while, Ms . Jane Brody in the NYT explains the symptoms and results of an illness called serotonin syndrome. And yes, too much of it can be fatal. Key symptoms to watch out for:

  • Cognitive-behavioral symptoms like confusion, disorientation, agitation, irritability, unresponsiveness and anxiety.
  • Neuromuscular symptoms like muscle spasms, exaggerated reflexes, muscular rigidity, tremors, loss of coordination and shivering.
  • Autonomic nervous system symptoms like fever, profuse sweating, rapid heart rate, raised blood pressure and dilated pupils.

(link attribution: Furious Seasons)

doggieIn another story that I find appalling, the FDA has approved a drug for carsick dogs. Yes, that’s right. Carsick dogs. soulful sepulcher first wrote about it and linked to the original story. How long before kids start taking this stuff to get high or something? You know something’s wrong when dogs can die from serotonin syndrome and feel better off of FDA-approved drugs. *shakes head* He’s cute, but he’ll just have to throw up.

Clinical Trial Phases: Handy to Know

Some of my readers may not have any clue about the difference between Phase I, II, or III of clinical trials, except that they’re, uh, different. Here’s info courtesy ClinicalTrials.gov:

"Study Phase
Most clinical trials are designated as phase I, II, or III, based on the type of questions that study is seeking to answer:

    * In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
    * In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
    * In Phase III
studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
    * In Phase IV studies, the post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations."

I’m sure a pharma blog will pick up on Pristiq soon enough.

Pristiq's FDA Chances: Depression – Yea; Menopause – Nay

As more info on Pristiq continues to roll out, I'll do my best to track them quite closely.

While Wyeth scrambles to resolve issues in its Puerto Rico plant to meet FDA standards, Ms. Kathleen Kerr of Newsday recently reported on Pristiq's potential to be approved for use in depression and hot flashes resulting from menopause. I was so excited to see some decent reporting on a mental health issue in a paper other than the NYT. It was also nice to see that it didn't end with "Shares of Wyeth fell 38 cents Friday to close at $51.50 on the New York Stock Exchange."

"If Pristiq wins Food and Drug Administration approval, it will be the first antidepressant and only non-hormonal remedy marketed specifically for hot flashes. But Pristiq isn't without problems – it poses rare suicide risks in young people."

Continue reading “Pristiq's FDA Chances: Depression – Yea; Menopause – Nay”

Pristiq gains ground with FDA

FDA approval for Pristiq (I'll refer to it as Pq occasionally) is contingent upon Wyeth's handling of "quality control problems… made to the satisfaction of federal inspectors." As I'd previously mentioned before, Wyeth has built an amazingly similar medication based on Effexor. Wyeth is trying to market Pristiq as an antidepressant and treatment for vasomotor symptoms (hot flashes during menopause). Wyeth is significantly banking on Pristiq since their $3.5 billion Effexor XR will lose its patent in a few years, allowing other companies to make venlafaxine generics.

Some of the "quality control" problems Wyeth is experiencing:

  • unclear whether Pq keeps depressive episodes at bay
  • efficacy at low doses and in young kids
  • severe nausea in 50 percent of patients in the clinical trials

Reuters' article notes this, though:

"But the studies do not need to be completed prior to approval of the new depression pill."

While Wyeth has admitted that Pq is "structurally related" to Effexor, it "has not yet disclosed if Pristiq has any advantages over Effexor XR, other than to say it would be an alternative to existing treatments."

But it has acknowledged the newer drug caused nausea in about one-half of patients in clinical trials.

Wyeth is banking on patients sticking out the nausea for one week (it supposedly subsides after that) or a 50 mg pill that would be more effective than the whopping 400 mg they used in earlier phases of the clinical trials.

"The company said it will not launch Pristiq until it obtains results from the low-dose trials. Moreover, Wyeth said the timing of the launch also will depend on progress of the FDA's ongoing review of Pristiq as a possible non-hormonal treatment for hot flashes. The FDA is scheduled to decide on the hot flashes indication in April."

Wyeth wants to be absolutely sure they can cover all of their bases in an effort not to lose a single portion on their market share — from those who can tolerate low doses at 50 mg to those who need to go 400 mg and up.

"A G Edwards analyst Joseph Tooley has predicted Pristiq will garner annual sales of $1.4 billion by 2011 — about $1 billion from use against depression and the remainder for menopausal symptoms."

Getting not only psychiatrists to prescribe the drug, but also OB/GYNs is a clever move on their part.

Loose Screws Mental Health News

Yay for the New York Times! Alex Berenson, doggedly keeping up on the Zyprexa story, has written an article about how state prosecutors in Vermont and Illinois are now demanding that Eli Lilly submits documents to them about their marketing practices of Zyprexa. Something I didn’t know:

“Federal prosecutors in Philadelphia have also recently accelerated their own investigation into Lilly’s marketing of Zyprexa.”

My residence in the Philly area has prompted me to follow this closely now. More juicy information:

“In a statement yesterday, Lilly said it would cooperate with the investigations and had done nothing wrong. ‘We intend to cooperate with the Illinois attorney general’s civil investigative demand relating to Zyprexa,’ the company said.

While the investigation being led by Illinois is civil, other investigations into Lilly’s conduct are both civil and criminal. [emphasis mine] Attorneys general in California and Florida may seek to recover Medicaid payments that the states made for Zyprexa. Any fine or cost recovery could be sizable, because Zyprexa has been a commercial success.”

Because investigators need to search through more than 10,000 documents relating to Zyprexa and its marketing and talk to former and current employees about the matter, it could take years for anything to happen. Berenson’s last paragraph at the end brought my excitement to a quick halt:

“As long as drug makers comply with federal requirements to provide data about their products to the Food and Drug Administration, companies have a relatively strong defense against criminal prosecution, according to lawyers who are experts in drug marketing.”

Great. So as long as Lilly complies with the FDA and state and federal prosecutors, they can escape criminal prosecution. Please don’t tell families who have loved ones who died over this medication. Lilly’s settlements are nice and all, but money is never restitution for someone’s death. I’ll soon have a post up about how Pfizer had this issue with Neurontin from 2002-2004. They, too, had to pay more than $430 million to settle lawsuits on civil and criminal charges. Pfizer plead guilty; let’s see if Eli Lilly follow suit (no pun intended).

Andre WatersI’ve been a little late on the bus with this, but I’ve previously written about Andre Waters who killed himself in November. Despite theories of depression surrounding his suicide, a neurologist has claimed that Waters sustained brain damage from playing football which triggered his depression and led to his death. Dr. Bennet Omalu, an expert in forensic pathology, says that Water’s brain tissue “had degenerated into that of an 85-year-old man with similar characteristics as those of early-stage Alzheimer’s victims.” Omalu gets pretty grim though:

“If [Waters] had lived, within 10 or 15 years ‘Andre Waters would have been fully incapacitated.'”

The NFL has no comment.

doggieAs I’ve been trying to tell my husband recently, pets can relieve symptoms of depression. Come on, who can be sad when you’ve got an happy little dog wagging its tail at you with bundles of love? (I’m thinking cute little Yorkies or friendly Golden Retrievers.) Owning a pet can have great mental health benefits:

  • Can reduce anxiety
  • Induce social contact
  • Promote a better quality of life
  • Help kids develop higher self-esteem and lower levels of fear

The only downside: animals can cause stress. But it seems like the stressors can be addressed, i.e. animal training, neutering. (source: The Trouble With Spikol)

Also linked to by Liz Spikol, another interesting mental illness combatant: sports therapy. It seems that it can help those suffering from PTSD, abuse, amnesia, and shyness. Italian doctors, however, a testing to see if soccer can treat illnesses like depression and schizophrenia. This should be interesting.

Oh, and NOTHING to do with mental illness, but I found this NYT article on weight loss and maintaining it quite interesting.