An increasing number of type 2 diabetes patients in the US are being treated by an increasingly complex mix of therapies, according to a study in the Archives of Internal Medicine, which questions whether the meds are actually going to improve outcomes.

Between 1994 and 2007, the estimated number of yearly patient visits to treat diabetes increased from 25 million to 36 million. During the period reviewed by the study, the number of doctor visits in which only one drug was prescribed decreased from 82 percent to 47 percent, and the average number of medications prescribed per treated patient rose from 1.14 to 1.63.

By 2007, biguanides (54 percent of treatment visits) and glitazones (28 percent of visits) were leading therapeutic classes. Increasing use of glitazones, newer insulins, sitagliptin phosphate, and exenatide largely accounted for recent increases in the mean cost per prescription ($56 in 2001 to $76 in 2007) and aggregate drug expenditures ($6.7 billion in 2001 to $12.5 billion in 2007). Avandia and Actos are glitazones, by the way, and so perhaps expenditures may slow, given recent warnings.

The upshot: “Increasingly complex and costly diabetes treatments are being applied to an increasing population,” the authors write. “The magnitude of these rapid changes raises concerns about whether these more costly therapies will result in proportionately improved outcomes” (here is the full study).

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Such as? Scarring and tissue damage, among other serious complications. That’s what an FDA advisory panel concluded at a meeting to review products from Allergan and Medicis Pharmaceuticals. FDA staffers told the panel that current prescribing info inaccurately describes most side effects as quickly noticeable and temporary, Bloomberg News writes.

About 1.36 million women and 84,000 men opted last year to get injections of animal collagens or chemicals to smooth facial skin and reduce signs of aging, according to the American Society for Aesthetic Plastic Surgery. Briefing documents filed with the FDA listed 930 side effect reports between January 2003 and September 2008 (please see page 23) with such products as Medicis’ Restylane and Allergan’s Juvederm. Actual numbers could be higher, of course, because reporting can be cumbersome.

“The labeling should be modified to reflect what we’re learning further about the products” through post-approval studies and reported side effects, panel member Mary McGrath, a professor of surgery at the University of California in San Francisco, said at the meeting. The panel, however, didn’t take a formal vote, and recommendations are not binding on the FDA.

The injections are generally given by doctors who have the responsibility to spell out risks and benefits to patients. Some injections that resulted in side effects may have been performed “by untrained personnel or in settings other than health clinics or doctors’ offices,” the FDA said in briefing documents released before the meeting.

An executive with the device maker reveals that a subpoena was issued by the US Department of Justice concerning unapproved use of its Infuse Bone Graft product, Dow Jones reports. The disclosure comes on the same day Medtronic reported soft spinal-product sales in its recently concluded fiscal second quarter, due in part to flat Infuse sales.

The product is specifically approved for use in the lower back but has commonly been used in other areas. Sales in the recent quarter were hurt by a public-health notice warning against off-label use. Also, “related negative press coverage and payer pushback created some significant new hurdles,” Bill Hawkins, Medtronic’s chairman and chief executive, told analysts on a teleconference call today.

Last month, you may recall, two Senate committees wrote Medtronic seeking info about consulting contracts given doctors over its Infuse Bone Graft, which is approved for use in the lower spine, but has been linked to life-threatening complications. There are also questions about complications suffered by patients who underwent off-label procedures involving use in other parts of the spine (back story).

The move comes after news broke of a lawsuit brought by a former Medtronic lawyer, who alleged the device maker gave surgeons all sorts of interesting goodies to use its spinal implants, including regular entertainment at a Memphis strip club, trips to Alaska and patent royalties on inventions they played no part in devising (back story). The relationships with docs generated another lawsuit brought by two other former Medtronic employees, who filed complaints against docs, specifically.

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Yes, we are still very much here. But we are spending time reviewing interesting story possibilities and meeting with interesting people. However, we do not want to let interesting items get away from us - or you. So here are a few worth noting…

The House Energy & Commerce Committee is now also investigating an FDA no-bid public relations contract awarded a firm with ties to one or more FDA personnel. You can read the letter to FDA commish Andy von Eschenbach here.

Johnson & Johnson passed on the chance to renew its lucrative global sponsorship deal with the Olympics. The International Olympics Committee confirmed that the health care giant would not renew its top-level sponsorship, which worth up to $100 million, according to Sports Business Journal.

AstraZeneca named Rich Fante president of its US business, replacing Tony Zook, who was recently named president of MedImmune, which the drugmaker acquired last year. Zook also is ceo of AZ North America and head of global marketing. Fante previously led marketing for all AZ brands in the US as vp brand strategy and portfolio operations.

…you’ve seen them all? A review for the American College of Physicians finds that there is no clinically significant difference in efficacy, effectiveness, or quality of life among different antidepressants - SSRIs, SNRIs, SSNRIs, or other second-generation pills - for treating an acute bout of major depressive disorder. Just think of all the marketing money spent to differentiate one pill from another.

The findings, which were compiled after reviewing 200 studies and are published in the Annals of Internal Medicine this week, form the basis for new guidelines for physicians, who are advised to select a second-generation antidepressant on the basis of adverse effects, cost, and patient preferences.

And what about suicidality? The review found that “no particular drug has an excess risk compared with any other drug in this class.” However, patients receiving SSRIs had an increased risk for nonfatal suicide attempts. SSRIs would include Lilly’s Prozac, Pfizer’s Zoloft and Glaxo’s Paxil.

Several of the experts who reviewed the 200 studies, by the way, have ties to Glaxo, which also sells Wellbutrin, among other drugmakers.

Twice this year, Cephalon has sharply raised the price of its Provigil narcolepsy drug, which is now 28 percent more expensive than in March and 74 percent more expensive than four years ago, and the drugmaker said recently it plans to continue raising the price, The Wall Street Journal writes.

The Provigil price increases - the average wholesale price is now $8.71 a tablet - are an extreme example of a common tactic drugmakers employ in the US to boost profits and steer patients away from cheaper generics, the paper continues.

Here’s how it works: Knowing that Provigil will face generic competition in 2012 as its patent nears expiration, Cephalon is planning to launch a longer-acting version of the drug called Nuvigil next year. To convert patients from Provigil to Nuvigil, Cephalon has suggested in investor presentations it will price Nuvigil lower than the sharply increased price of Provigil, the Journal writes.

By the time generic versions of Provigil arrive, Cephalon hopes that most Provigil users will have switched to the less-expensive Nuvigil, which has patent protection until 2023. Meanwhile, Cephalon will have maximized its Provigil revenue with the repeated price hikes, the paper explains.

“You should expect that we will likely raise Provigil prices to try to create an incentive for the reimbursers to preferentially move to Nuvigil,” Chip Merritt, Cephalon’s vp of investor relations, told a recent health care conference, according to a transcript. Cephalon acknowledges regularly increasing prices, although until this year, the drugmaker says Provigil prices were rarely raised and offers a patient assistance program, but that couldn’t accommodate everyone who sought help.

Interestingly, just last week, Cephalon ceo Frank Baldino told a biotech conference that drugmakers should lower prices to avoid being in the crosshairs of the federal government. “It’s time to reconsider the pricing model,” he said, according to Dow Jones. “Perhaps it’s time to move toward a volume model” in which higher sales volumes make up for lower prices.

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Now that the US Supreme Court has heard her case (this is the transcript), the Vermont musician is getting more assertive about publicizing her plight and the issues involved. We interviewed her earlier this year (take a look), but now everyone has a chance to ask Levine the loss of her right arm in a clinic after being administered Wyeth’s Phenergan. She sued for inadequate labeling and won; Wyeth is appealing.

At issue is the notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. The court’s decision, therefore, will be closely watched because its ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.

The live chat takes place at 3 pm EST today and you can join by going to FireDogLake. Be advised that you must register, free of charge, in order to comment. The discussion is being arranged by the Alliance for Justice, which recently released a documentary about preemption that features Levine.

A jury in an Illinois state court awarded the money to the family of Janice DiCosolo, 38, who died in February 2004, because the patch she was wearing delivered a fatal dose of the fentanyl narcotice, which is the main ingredient in Duragesic, Bloomberg News reports.

This if J&J’s fourth loss in as many trials over the past two years and it took the jury less than two days to deliberate. The patch, by the way, is made by Alza and distributed by Janssen Pharmaceutica, and generated $1.16 billion in sales last year for J&J, making Duragesic one of its best-selling products, the news service writes.

“We disagree with the jury’s verdict,” a J&J spokesman writes Bloomberg. “We are considering our options for an appeal.”

The lawsuit was filed by DiCosolo’s husband, John, 45, and the couple had three children. The trial began Oct. 29, one day after a jury in Sanford, Florida, awarded more than $13 million to the family of Susan Hodgemire, a 34-year-old mother of five who died after using a Duragesic patch in 2002.

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We are reminded to again share with you a favorite saying of the morning mayor: Every brand new day should be unwrapped like a precious gift. So go ahead, tug on the ribbon. And then, digest a few items while we hustle the short people off to the schoolhouse…

Fitch Slashes Merck Outlook To Negative (Press Release)

Most Zyrtec Users Didn’t Switch To OTC (Medical Marketing & Media)

Genentech Reports Another PML Case With Raptiva (PharmaTimes)

Judge Tosses Paxil Case (The Legal Intelligencer)

Novartis Fund Is Not A Venture Capitalist (Xconomy.com)

Merck Drug Fails To Slow Alzheimer’s (Yahoo/Reuters)

Recession Won’t Hurt CROs In India (The Economic Times)

Forever known as the big melting pot, New York City is where who-knows-how-many different languages are spoken. So it stands to reason that it just may be useful to have prescription info available in something other than English.

So after an investigation by New York State Attorney General Andrew Cuomo, two big drug chains, CVS and Rite-Aid, will now provide spoken and written translations to customers in Spanish, Chinese, Italian, Russian, French and Polish. (Sorry, no Korean, Hebrew, Arabic, Greek or Swahili, among others, so those folks will have to know English or pray they can avoid allergic reactions and side effects).

This raises a couple of thoughts. One: who should or will take responsbility for these translations? Imagine the concerns among pharmacists and drugmakers over legal liability. The other is this: what about those of us who already speak English? Shouldn’t there be a translation that makes it easier to understand product labeling? Skip the irony. Those abbreviated print-outs don’t cut it.

Hat tip to PAL blog