Pharma's "me-too" drugs face skeptical docs and health insurers

As patents expire on a variety of drugmakers’ moneymakers, pharma companies have gone to great lengths to structurally reinvent the successful drugs then tout the benefits that differ from their predecessors.

InvegaCase in point — Johnson & Johnson’s Invega. Invega is the successor to the popular antipsychotic drug, Risperdal, and competitor to AstraZeneca’s widely used antipsychotic Seroquel. Scott Hensley at The Wall Street Journal’s Health Blog (WSJ) reports that Risperdal is going generic in June. Gianna at Beyond Meds recently said it will not. According to the Dow Jones Newswires (DJN), these “junior” drugs face skepticism from health insurers and doctors. California-based Kaiser Permanente and Minneapolis-based UnitedHealth Group Inc. (UNH) are example of companies that have somewhat discouraged use of the drug. Kaiser doesn’t cover Invega at all, and members of UNH are required to pay higher copays for the brand name. The wire reports New York-based psychiatrist Jeffrey Lieberman wasn’t “buying it” the difference between Invega and Risperdal.

Invega is “basically a me-too drug, and the company hasn’t done the studies that would be required to really distinguish it,” Lieberman, chairman of the psychiatry department at Columbia University’s medical school told Peter Loftus of Dow Jones Newswires.

Ouch.

The blog also quotes Daniel Carlat from the The Carlat Psychiatry Report.

Dan Carlat, a psychiatrist and a tough critic of Invega, wrote that J&J’s “marketing team apparently missed the fact that the word in the English language that sounds most like “Invega” is “inveigle,” meaning “to entice, lure, or ensnare by flattery or artful talk or inducements.’ ” He asked doctors: “Will you be doing your patients a favor by taking the plunge? Or will you simply be giving them the same wine in a fancier bottle?”

Even J&J’s Group Chairman of Pharmaceuticals, David Norton, admitted that Invega is a tough sell.

“We need to do a better job at drawing a differentiation in a difficult-to-treat population.

So far, Invega sales have been incredibly disappointing compared to the Risperdal blockbuster.

Wyeth (antidepressant Effexor XR cum Pristiq) and Shire (ADHD drug Adderall XR cum Vyvanse) face the same uphill battle. Wyeth’s Effexor faces generic competition from Teva Pharmaceuticals despite efforts to halt generic sales of the drug and the patent on Shire’s Adderall is set to expire next year.

Hensley, in his analysis, raises a question in which the answer remains to be seen:

Cheap generics abound to treat a broad assortment of illnesses these days. What’s the point, the critics ask, of paying more for drugs that are at best only slight improvements over tried and true medicines available at bargain prices?

It’s something that I’ve questioned myself.

In an attempt to have the “me-too” drugs compete with its derivative, both Wyeth and Shire are slashing their prices, or as the DJN reported, “emphasizing improved dosing for the newer drugs.” Although Pristiq’s efficacy comes at higher doses, it’s being priced 20 percent lower than Effexor.

[Deutsche Bank pharmaceutical analyst Barbara Ryan] thinks the odds of
Pristiq’s success are slim because it appears to offer few benefits
beyond those of Effexor.

That remains to be seen. So far, a few patients have commented on my blog that Pristiq has already begun to help them. I haven’t seen any DTC ads for Pristiq so I can only assume that drug reps are doing a fine marketing job at selling the different benefits of the drug to doctors.

Vyvanse, on the other hand, is looking promising for Shire, already having 7 percent of U.S. ADHD drug prescriptions. Chief Executive Matthew Emmens says the drug is chemically different from Adderall (aren’t they all?) and has better pricing. Shire expects to beat Adderall’s 26 percent peak market share. Seems like a lofty goal to me.

As for Invega, J&J is currently seeking FDA approval to use the drug for bipolar disorder and not just treatment for schizophrenia. It is also l0oking to get approval for an injectable Invega XR.

(Invega logo from Janssen.com)

Depression Overawareness and Overmedication Week

The Pursuit of Happiness

This post kicks off Depression Overawareness and Overmedication Week.

Two weeks ago, CLPsych and Gianna, among others, celebrated Bipolar Overawareness Week. To cap off Mental Health Awareness Month, I’ve declared this last week of May Depression Overawareness and Overmedication Week. Use this checklist to identify whether you may possibly be “overaware” and “overmedicated” for depression:

  • If you’re on Zoloft because you’ve never been sad or anxious.
  • If you get a prescription for Lexapro on Thursday because you had a bad day on Tuesday.
  • If you take Paxil because you’re never restless or irritable.
  • If you are on Pristiq as a result of sadness and guilt over your Wii-related injury (eg, throwing your shoulder out or tripping over the coffee table).
  • If you are on Celexa because you hate the job that you disliked anyway before you began the medication.
  • If you are on Cymbalta because you are tired after normal long, exhausting days at your job(s).
  • If you are on Effexor only because you overate during the holidays.
  • If you take Prozac because you’ve never had passing thoughts of suicide.

If you meet any of the criteria above, this is a medical emergency. You are overaware and overmedicated. Go see your doctor immediately and discuss treatment options that involve non-medication and/or talk therapy.

Now, the disclaimer.
The checklist above is satire. It is not intended to poke fun at those who suffer with real clinical depression (of which I am one). It is intended to mock the extremely high number of people in the U.S. who are diagnosed with depression and medicated with antidepressants. This is not a medically based checklist for anything. It is not a professional recommendation or intended for professional use. It is not intended to be serious. In fact, it is not intended to be seriously serious. If you take this to your doctor, he or she will probably diagnose you with something other than depression. If you have been offended by this post, don’t be; you shouldn’t come close to meeting the criteria above. And if you do, then you really should go to a doctor. While I meet the criterion for sadness over my Wii-related injury, I don’t take Pristiq for it. If you have something nice to say, click on the Comments link below. If you don’t have something nice to say, click on the Comments link below.

(comic from problogs.com)

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:

Continue reading “My official position on pharmaceutical companies and psychotropic meds”

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

PristiqThe 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.

Pristiq receives approval from FDA

PristiqMore 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)

Continue reading “Pristiq receives approval from FDA”

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.

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.