Poor Wyeth — New drug delayed in FDA approval

From Forbes.com:

Wyeth Pharmaceuticals just can't seem to catch a break. The company is not only increasingly worried that it will lose a large chunk of its revenues to generic competition, it also faces the ongoing threat that its pipeline is starting to go dry. A further delay in the approval of its postmenopausal osteoporosis drug has become one more nail in the pharma company's coffin.

The drug, bazedoxifene, has had a hard time getting approval from the FDA since April 2007.  The FDA is concerned about bazedoxifene's effects on causing myocardial infarctions or blood clots.

This is some pretty disheartening (to say the least) news considering that Effexor will soon be going generic and Pristiq has received some less-than-stellar reviews.

My official position on pharmaceutical companies and psychotropic meds

In previous posts, perhaps I’ve come off a little bit as “I hate Big Pharma.” I did. For a while.

I’m not in love with pharmaceutical companies either. I’ve quoted it before but “to whom much is given, much is required.” As a result of accumulating knowledge through reading and research, I know a whole lot more about pharmaceutical companies, the treatment options they put out there, and what lengths they go to get those treatments out there. Most of the things I read are negative. Much of what I’ve said is negative. Perhaps “ignorance is bliss.” My husband said this recently:

“The Internet is the great bitching ground. No one’s going to talk about how great medication is. Everyone’s going to go on and just bitch about side effects and bad experiences.”

I agree. “Effexor really helped me feel better today” doesn’t make for an interesting blog post. No one pays attention to medication when it’s working, however, everyone will complain if something is going wrong. The most “positive” drug comments I’ve seen are on my seemingly “negative” posts from people who are being helped by a drug.

Take, for instance, the following comment from Suffering:

BJ Harroun left this comment for me on one of my posts Pristiq's FDA Chances: Depression – Yea; Menopause – Nay:

I have just completed my first two weeks on Pristiq. I have suffered from MDD for 35 years. I cannot take Effexor because it increases my appetite. Pristiq has really helped me. I have taken everything and I think I have finally found something that works for me. Don't dismiss this drug because it is an Effexor metabolite.

I didn't expect to see much of a difference between Pristiq and Effexor in terms of side effects since I figure since they're from the same class (SNRI). But I'm glad that Pristiq seems to be helping BJ. It would behoove me to take a look at the PIs for Effexor and Pristiq and check out the clinical trial data and see how they shaped out differently. But there's only so much time for me during the day.

The Effexor Chronicles: Lucky Her

One woman had a near trouble-free time getting off of Effexor.

I was taking effexor for about 4 months due to having a anxiaty attack one day.

One day I just felt like I was ready to get off of them.

I started by slowly bringing down my dosage. Did that for 2 weeks. The 3rd week I stopped taking them all together.

The worst sympton I felt was the dizzy feeling, I think they call it vertigo. That lasted for up to 2 weeks after stopping the medication.

I am proud to say I am now completly effexer free, with no side affects any longer. It can be done. Just go slow !

Good luck.

Wyeth Pushing Pristiq Hard

The Wall Street Journal reports that Wyeth, desperate to make money off of its Effexor XR-knockoff, Pristiq, says it will slash the antidepressant at a 20% discount compared to Effexor’s price. The price slash, CNN money reports, is a result of less-than-impressive clinical trial data on Pristiq’s “safety and effectiveness.”

Wyeth SVP Joe Mahady told analysts that Pristiq will sell for a flat $3.41 per tablet for both mid- and high-dose, Dow Jones Newswires’ Peter Loftus reports.

Wyeth, apparently, has done this in the past. Back when it was known as American Home Products, the company slashed its price on Protonix, its heartburn drug, to compete with AstraZeneca’s Prilosec. The drug generated $1.9 billion in profits for Wyeth last year. CNN Money reports that Teva Pharmaceuticals and Sun Pharmaceuticals began selling the generic version of the drug and handily cut into Wyeth’s profits: the company reported a 4.6% decline in profit and a 66% drop in sales for the drug for the first-quarter. What will happen with Pristiq remains to be seen. I’m not sure that doctors in 2010 will want to dole out prescriptions for Pristiq when they can save patients—and insurance companies—money by prescribing what will then be known as venlafaxine. WSJ also notes:

A month’s supply of sertraline (Pfizer’s old hit Zoloft) or fluoxetine (Lilly’s Prozac) goes for 50 cents a day at drugstore.com.

$3.41 or $0.50 per tablet. It wouldn’t surprise me if some insurance companies choose to exclude Pristiq from its list of covered drugs. Regardless, Wyeth expects sales of the drug to exceed $1 billion in its first year.

The drug will hit the shelves in May.

Wyeth reps no like Pristiq

Oof. I'm just starting to read The Carlat Psychiatry Blog and stumbled upon this post about Wyeth drug reps trashing Pristiq. Wow. Carlat pulled an excerpt of a Wyeth rep mocking Pristiq's new marketing slogan: "People, Passion, Performance… Pristiq!"

"PEOPLE – 1/2 of you will be gone in less than 27 days

PASSION – There is no passion now, but for those that remain with Wyeth, we will bribe the passion out of you by taking you to Vegas for 4 days.

PERFORMANCE – You thought it was hard to reach your performance incentive before? Wait until 2nd quarter

PRISTIQ – Good luck selling both Effexor XR and Pristiq at the same time. So Dr., would you like to hear about my antidepressant that has been around for 12 years, with proven efficacy with the ability to titrate the dose as need to better care for each patient's needs that will have generic competition in 4 months, or would you like to hear about my brand new antidepressant with one dose, less indications and less evidence of efficacy? You want me to choose, let me check with my bonus plan to see which one pays more."

Carlat:

If this is the typical attitude within the Pristiq sales force, Wyeth may end up a little shy of the blockbuster they were hoping for!

I couldn't have said it better myself.

Pristiq receives approval from FDA

More than a year ago, I promised to keep tabs on Wyeth’s new (renamed, rather) drug Pristiq. So I’m living up to it.

On February 29, 2008, the FDA granted Wyeth approval to move forward with putting the drug out on the market.

Wyeth said the company planned a big sales effort to introduce the product to psychiatrists and primary care doctors.

There’s a problem with that sentence. I’ll give you a second to figure out what’s wrong with it. Haven’t got it yet?

Primary care doctors. PCP should not be in the business of prescribing or providing psych meds. I’ve gone on and on about it at length before, but I’ll mention it again. PCPs are trained to treat overall conditions that have no need of referral to specialists. Think about it this way: If your psychiatrist prescribed anti-inflammatory medication because you mentioned that you’ve been having problems with your foot, you’d be taken aback, right? If a dermatologist prescribed heartburn medication after a patient mentioned he’d been having heartburn trouble, that would seem almost illogical, wouldn’t it?

(Pristiq logo from Pristiq.com)

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.

Dr. 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.

Dr. 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.

Wyeth looking for Pristiq's FDA approval in 2008

Depressed Americans will be spared of Pristiq for 1 year. According to an article from Reuters, "positive" data has raised investors’ hopes in Wyeth’s future star drug.

"The trial data showed low doses of Pristiq were effective against both depression and hot flashes and caused less nausea than was seen in prior studies of higher doses. Although the new data will take more time for regulators to analyze, it could bolster prospects for eventual approval and commercial success of the drug."

My best guess? Pharma reps will push Pristiq at higher dosages and doctors will prescribe it at higher dosages with a minimal warning of nausea. I’d like to know the highest dosage tolerated with the least amount of nausea. And really, what is considered a low dosage anyway? The difference between 37.5 mg of Effexor and 300 mg of Effexor is significant despite the fact people told me that the dosages didn’t compare to that of Lexapro’s. (It was supposedly less powerful than Lexapro.)

Anyway, I’ll stop my rants. 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.

Tips for proper self-withdrawal from medication(s)

Gianna, a reader of this site, has a great and informative blog, Bipolar Blast. In a recent post, she gives some tips for proper psych drug withdrawal. This is particularly helpful for those dealing with severe antidepressant withdrawal effects. For me, Effexor comes to mind. I also think about "Honey’s" experience with Zoloft. Not only does Gianna emphasize diet and nutrition as an important part of the process, but she also delves into proper titration. (Many people think that the diet and nutrition thing is obvious, but many people overlook that important piece of recovery.)

I understand that many people – especially in the psych world – think Peter Breggin’s a wack job, but he can have some good points. Gianna refers to Breggin’s 10% rule:

"Breggin suggests what has come to be known the 10% rule. Any given drug should not be reduced anymore than 10% at a time. Once a taper is complete the next taper should not exceed 10% of the new dose. Therefore, the milligram, then fraction of milligram amount decreases with each new taper. I’ve found that I have to sometimes go in even smaller amounts. As low as 5% and sometimes people go as small as 2.5%–for people on benzodiazepines it is not unusual to go in even smaller amounts. Cutting pills is not always enough. Sometimes liquid titration is necessary. This may involve dissolving the smallest dose pill in water, club soda or even alcohol, which can then be diluted with water, then using a syringe to cut down milliliters at a time. Medications also sometimes come in liquid form and can be gotten by prescription. It should be noted that some medications should not be dissolved. Especially time released medications. This would be extremely dangerous."

Gianna clearly knows what she’s talking about. Head on over to her site to read the rest of the post.