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)

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Loose Screws Mental Health News

If the state gets its way, hundreds of children could be put in foster homes, in what could be a wrenching cultural adjustment that may require intensive counseling.

Wow. That's all I can say. How do you place 400 different children in foster homes and ensure they'll get proper care? You can't.

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.

Johnson & Johnson subpoenaed

RisperdalI was reading the business section of my Metro paper this morning and noticed that Johnson & Johnson was subpoenaed in Boston, San Francisco, and Philly. According to the Associated Press, it is in relation to “sales and marketing of three drugs.”  The drugs? Risperdal, Topamax and Natrecor. Risperdal is used for schizophrenia and bipolar mania, Topamax is an epilepsy drug (if not approved for bipolar use, probably used off-label for that purpose), and Natrecor is used for patients with heart disease.

The latest subpoenas seek information about the corporate supervision and oversight of J&J’s Janssen, Ortho-McNeil and Scios subsidiaries, which sell the drugs, J&J said.

J&J posted Risperdal sales of $4.18 billion last year, an 18 per cent increase from 2005. In November 2005, Janssen received a subpoena from the U.S. Attorney’s Office in Philadelphia seeking information about Risperdal marketing and adverse reactions to the drug.

Topamax sales were $2.03 billion last year, a 21 per cent increase from 2005. Ortho-McNeil received a subpoena from the U.S. Attorney’s Office in Boston in December 2003 seeking documents relating to the drug’s marketing, including alleged “off-label” marketing, J&J said in the SEC filing. Doctors often prescribe drugs for uses not described on U.S. Food and Drug Administration-approved labels, but pharmaceutical companies cannot market products for off-label usage.

Do we have another Zyprexa case on our hands?

Between the Risperdal investigations, the Zyprexa lawsuits, the Seroquel lawsuits, BMS’s recent mysterious settlement with the US Attorney in New Jersey (it’s not clear if that was related to Abilify, but I bet it was), plus the pending Congressional investigation of Zyprexa and Seroquel, it looks like the wonder drugs are in a world of trouble. In my adult life, I cannot recall a class of drugs that have ended up in such a pickle before. Nor have I seen such a class of drugs that were once touted as cures turn into such duds. The whole thing is just weird.

The wonder drugs are probably in trouble, but they won’t get pulled off the market and I doubt they’ll get more coverage than how the situation affects the company’s stocks. (This is one area where I’d like to be wrong.) But I agree with Dawdy’s assessment that a class of drugs have never been more criticized than atypicals. There have been individual instances of investigations within a class of drugs, but not a whole slew of them. What leads companies to shady practices in this area when it comes to mental health? Perhaps it’s because the drugs have not been conclusively proven to be the savior they are touted as. Or maybe it’s because the hypotheses – that’s really what the explanations of how these drugs work are – have enough of an effect from clinical trials to market and make a substantial profit. I’d venture to say that psych drugs are the only class of drugs that are marketed based on hypothesis only and not conclusive evidence.

Read more at Furious Seasons.

Loose Screws Mental Health News

NAMI is touting a new atypical… in the press release for Johnson & Johnson. Michael J. Fitzpatrick, executive director of NAMI lent a statement  in J&J’s pr about Risperdal’s sibling, Invega. *sniff, sniff* Something smells fishy about this. Makes me wonder if these non-profits bag money from Big Pharma under the table… (source: Furious Seasons)
An electronic ping sent from Sprint to the police helped save the life of a college student who tried to commit suicide, according to Newsday. A ping also helped save the lives of James Kim’s wife and children after getting stuck in the mountains of Oregon. This ping thing is interesting. Especially since Newsday needs to put quotes around it because ping isn’t a real vocabulary word… yet.

Merry Christmas to all and to all a good night.

ADDENDUM: Oooh, ooh, ooh – just found out: Any family that has a minor who may have consumed Paxil or Paxil CR is eligible for a stake in a $63.8 million settlement with GlaxoSmithKline. More info about the settlement at paxilpediatricsettlement.com. Apparently, it seems as though GSK covered up information about the medications’ safety and efficacy. This is one I’d like to learn more about considering I’ve been on Paxil. Not as a minor but the settlement raises questions  regarding GSK withholding information about Paxil’s safety and efficacy regarding adults.

Is it now fashionable to sue pharma companies for not making all of their information public?