Thursday, 28 June 2012

Biopharmaceutical Company-Herborium Group Reports-Phase 2 Clinical Trial-Mycobacteria

Med Centro Becomes First SuccessEHS Client to Go Live in Puerto Rico

BIRMINGHAM, Ala., June 27, 2012 /PRNewswire/ -- On June 5, 2012, Med Centro became the first SuccessEHS client in Puerto Rico to go live with the SuccessEHS solution, expanding the vendor's existing coverage in 48 states and the Virgin Islands.The go-live on June 5 took place... read more..


Insmed Announces First Patient Dosed in TARGET-NTM Phase 2 Clinical Trial of ARIKACE® in Patients with Non-Tuberculous Mycobacteria (NTM) Lung Disease

MONMOUTH JUNCTION, N.J., June 27, 2012 /PRNewswire/ -- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced that the first patient has been dosed in the Company's U.S. phase 2 clinical study of ARIKACE® (liposomal amikacin for inhalation) in... read more..


Herborium Group Reports Record 6 Month Revenues

FORT LEE, N.J., June 27, 2012 /PRNewswire/ -- Herborium Group, Inc., ( HBRM) www.herborium.com, a Botanical Therapeutics® Company announces today that its revenues   from AcnEase®, all botanical, proprietary acne treatment, grew over 25 percent in  the first ... read more..

Post-Traumatic Stress Disorder-Triwest Healthcare Alliance-Reimbursement Revenue

Kick Off Summer Vacation With Five Simple Tips to Safely Store Medicines While Traveling

Kick Off Summer Vacation With Five Simple Tips to Safely Store Medicines While Traveling
As Americans Pack Their Bags, CDC and CHPA Educational Foundation Remind Families to Pack Medicines Safely, Too WASHINGTON, June 27, 2012 /PRNewswire-USNewswire/ -- With summer here and... read more..


TriWest Healthcare Alliance Stands With Military Partners In Recognizing Post-Traumatic Stress Disorder Awareness Day

PHOENIX, June 27, 2012 /PRNewswire/ -- While today marks Post-Traumatic Stress Disorder (PTSD) Awareness Day,  TriWest Healthcare Alliance remains firm in its commitment to stand alongside its U.S. military and TRICARE partners in the mission to prevent PTSD and the effects it has on... read more..


California Pathology Practice Increases Reimbursement by 40%

ATLANTA, June 27, 2012 /PRNewswire/ -- Today's pathology practices face increasing billing complexities. Coding regulations are complicated, and penalties can be stiff if errors are made. Some physician groups miss valuable reimbursement revenue for certain services because they... read more..

Paula Deen Does Not Know Her Blood Sugar-Blood Glucose Levels-Prevention Magazine

Paula Deen Does Not Know Her Blood Sugar Numbers

Paula Deen, the TV celebrity southern-style chef and spokesperson for Novo Nordisk's diabetes treatment Victoza (see "Novo Nordisk Defends Choice of Paula Deen Over Anthony Bourdain (for example) as Celebrity Chef Spokesperson"), recounted for Prevention Magazine how she learned she had type 2 diabetes. Deen is featured on the cover of the May 2012 issue of Prevention (see cover on left).
When asked "How high was that blood sugar reading?" during a routine doctor visit more than 3 years ago, Deen said "I don't know. They just said it was high." Then her doctor said, "I'm going to start you on some medicine," and wham, bam, thank y'all ma'am, Deen started her secret life as a diabetic.
Furthermore, Deen does not remember her doctor saying anything about lifestyle changes. "Now, she might have," said Deen diplomatically, "but I don't recall coming out of that visit with a lot of literature. She just started me on the drug."
It's hard to believe any doctor worthy of treating a wealthy celebrity would not have given her a bit more education regarding living with diabetes. One important bit of education is "Know Your Blood Sugar Levels." That's the title of a National Institutes of Health National Diabetes Education Program pamphlet (see here). "If you have diabetes," says NIH, "keeping your blood glucose (sugar) numbers in your target range can help you feel good today and stay healthy in the future."
After Novo Nordisk approached her to be a spokesperson, Deen "asked the doctor if I could switch over from the [combo drug]" to Victoza. Of course, her doctor complied because Deen knows best, although she doesn't know her numbers (or choses not to say what they are). Or perhaps the doctor was also "approached" by Novo Nordisk.
Whatever! Deen is now taking not only Victoza but also metformin and "a small dose of Actos." I'm not an expert on diabetes treatments, but because Deen is on multiple drugs and because she hasn't revealed her initial high blood glucose reading, we will never know if Victoza is really helping her control her diabetes.
Deen has the right to keep her blood glucose levels and other medical information confidential. She also has the right not to reveal how much money Novo Nordisk is paying her. "I am being compensated for my time and work," said Deen.
But should pharmaceutical companies be required to reveal how much they pay celebrity spokespeople just as they are now required to reveal how much they pay physicians (celebrities or otherwise)? If Nike reveals that it paid Tiger Woods $105 million, why shouldn't pharma companies reveal how much they pay celebrities (including Phil Mickelson who is a paid ENBREL spokesperson; see here)? What are they hiding?
BTW, there seems to be a pattern of pharmaceutical celebrity spokespeople defending themselves in consumer magazines like Prevention. Mickelson, for example, "opened up" in an interview published in Arthritis Today (see "Phil Mickelson 'Opens Up" to Arthritis Today Magazine"). Of course, these magazines also make a lot of money from drug advertising. In fact, there is a nice 2-page ad spread for Victoza featuring Paula Deen in the same issue of Prevention as her less than "tell all" interview. In the ad, Deen is NOT depicted creating her famous bacon, cheeseburger, Krsipy Creme donut sandwich! (See the video of THAT here).
In a recent survey, I asked respondents to say whether they agreed or disagreed with the following statement: "Each pharmaceutical company should be required by law to publicly disclose how much money it pays every celebrity for being a spokesperson." 38% (N=112) said they "strongly agreed, " another 21% said the "somewhat agreed," and 36% said they strongly or somewhat disagreed.
One pharmaceutical company employee respondent made this comment: "What is the point of all this pharma reporting? If I tell you that Paula Deen is making $10M or $1M, what difference does it make? I'm sure she's ma read more..

Lung Cancer Deaths-Breast Cancer Risk-Moderate Exercise-Recurrent Strokes

Even Moderate Exercise Might Cut Breast Cancer Risk: Study

MONDAY, June 25 -- Women who exercise may cut their risk of breast cancer by as much as 30 percent, a new study suggests.Weight gain, however, may undermine the benefit of exercise, the researchers noted."Our study showed that moderate... read more..


Are Statins Less Helpful for Women?

MONDAY, June 25 -- The cholesterol-lowering drugs known as statins may be less effective for preventing death and recurrent strokes in women than in men, a new study suggests.A review of 11 trials found that statins such as Lipitor and Crestor... read more..


Lung Cancer Deaths Rise Among 'Boomer' Women in South

TUESDAY, June 26 -- Although the overall lung cancer rate in the United States has been declining in recent years, new research shows a troubling increase in lung cancer deaths among baby boomer women living in some southern and Midwestern... read more..

Wednesday, 27 June 2012

Low Vitamin D Levels-Bacterial Vaginosis-Harmful Bacteria-Hiv Transmission-Heart Problems

Low Vitamin D Levels Linked to Weight Gain in Older Women

TUESDAY, June 26 -- Older women with low levels of vitamin D, also known as the "sunshine vitamin," may be more likely to gain weight, a new study indicates.Researchers from the Kaiser Permanente Center for Health Research in Portland, Ore., said... read more..


Bacterial Vaginosis Increases Female-to-Male HIV Transmission Risk

TUESDAY, June 26 -- HIV-positive women with bacterial vaginosis, a disruption in the normal balance between healthy and harmful bacteria in the vagina, are three times more likely to pass HIV on to male sexual partners, according to a new... read more..


'Atkins'-Type Diets May Raise Risk of Heart Problems: Study

TUESDAY, June 26 -- Women who regularly eat a high-protein, low-carbohydrate diet may be raising their risk of heart disease and stroke by as much as 28 percent, a new study suggests.Although the absolute increase in risk is small -- four or five... read more..

Tuesday, 26 June 2012

Pharmaceutical Industry-Advisory Comments-Dissemination-Storyboards-Shire

Shire Seeks to Maintain YouTube 'Loophole' in FDA's Draft Guidelines for TV Ads

FDA has received several comments from the pharmaceutical industry regarding the agency's "Draft Guidance for Industry Direct-to-Consumer Television Advertisements." In past posts I reviewed comments from PhRMA (the drug industry U.S. trade association) and Sanofi (see here and here). In this post, I report on comments made by Shire (find Shire's comments here).
Shire, like Sanofi, Novo Nordisk and Boehringer Ingelheim (BI), believes that submission of a final recorded version of a TV ad for FDA approval prior to being aired would be "burdensome." Shire specifically cites the optional two-step process FDA suggested; i.e., first submit an annotated storyboard and then a final recorded version of the ad. "This sequential two-submission process would double the time and resource burden on sponsors as well as the Agency," says Shire.
Serial OPDP Review Blues
BI also mentioned the "burden" of a two-step process in its comments to the FDA (find them here). But BI was referring to the need to resubmit a new version of the ad after receiving critical comments from the FDA concerning the first version submitted for review. "BIPI is concerned with the incremental time and cost that would be incurred by sponsors to routinely produce and submit multiple broadcasts for the purpose of OPDP [FDA's Office of Prescription Drug Promotion] pre-dissemination review," says BI. "BIPI is similarly concerned that the repeated submissions of storyboards to capture serial sets of OPDP suggestions (i.e., the submission of modified storyboards for advisory comments following integration of initial advisory comments) would greatly increase the time, if not the cost, of producing DTC broadcast ads." BI says that it "behooves sponsors to ensure storyboards submitted for advisory comments are representative of the final ad and to ensure that the Agency's comments are incorporated into the filmed version." In other words, BI suggests FDA just look at storyboards and trust that the sponsor will create a final "filmed" ad that is revised according to FDA comments.Shire, however, was the only pharma company to point out a "loophole" that I revealed on Pharma Marketing Blog in March (see "A Loophole (?) in New FDA Guidance on Pre-Dissemination Review of TV Direct-to-Consumer Ads"). In that post, I said:
"FDA does not define what exactly it means by 'dissemination.' Perhaps it has defined this term elsewhere in it regulatory archives, but I assume in this case it means airing the ad on mass market TV. Does that include uploading the video to YouTube? A drug company could upload a video of a pre-approved ad to YouTube at the same time that it submits the video to FDA for 'pre-dissemination' review. The video can then be embedded in the drug.com website or promoted via Twitter."Shire pointed out the same lack of clarity in its comments. "...there has been increasing availability and use of vehicles other than broadcast TV to present video advertising, such as on-demand viewing via the Internet," says Shire. "Shire recommends that FDA affirm that the scope of the guidance includes only DTC advertisements disseminated through broadcast television."
FDA and the drug industry continue to see no need to issue any mandatory or even voluntary guidelines specifically for drug promotion via the Internet. Shire points out, for example, that there already is an "advisory review process" that applies to video advertisements disseminated through "other viewing platforms' (i.e., the Internet). That process (see here) says "a sponsor may voluntarily submit advertisements to FDA for comment prior to publication."
However, if "dissemination" is defined according to Shire's rules, then it is possible for a drug company to run a video ad on YouTube months before it airs the same ad on TV without having to submit anything to the FDA for review -- the current "advisory review process" that Shire refers to is voluntary.
As part of that process (e.g., su read more..

Monday, 25 June 2012

Inactive Ingredients-Active Ingredients-Rick Perry, Texas-Hamburger Meat-Social Media

Will Pharma Experience It's Own 'Pink Slime' Social Media Crisis?

No doubt you have heard about "pink slime," the beef additive made from leftover trimmings. According to an article in today's Wall Street Journal (here), "the additive, which has long been used as a cheap filler in hamburger meat without anyone knowing or caring, has become the latest example of a product to fall prey to a social-media feeding frenzy after celebrity chef Jamie Oliver detailed how it is made in a TV special. Facebook, Twitter and other social media sites took it from there. Supermarkets and school districts across the country have been shunning it after mounting public pressure."
To counteract that "public pressure," which Tyson Foods Chief Operating Officer Jim Lochner said is merely a "two-week event," USDA and governors from several "pink slime" producing states (eg, Rick Perry, Texas) are mounting a counterattack. Iowa Gov. Terry Branstad said "We're going to consume it. We'll do everything we can to set the record straight."
"This is so clearly a movement that's been driven by consumers," said Willy Ritch, a spokesman for U.S. Rep. Chellie Pingree (D., Maine), who is pushing for a ban of the filler in school lunches.
USDA chief Tom Vilsack pointed to the difficulty of getting ahead of opposition to a product -- even if it is deemed safe by the government -- in a world fueled by social media. He also highlighted a disconnect that continues to grow between people and where their food comes from.
It's possible that the drug industry will one day face it own "pink slime" crisis because there is also a "disconnect" between consumers and where their drugs come from and the ingredients they contain.
Recently, we have seen cases where active ingredients in medicines have been replaced by miscellaneous substances having no medical benefit and cases where manufacturing problems have led to contamination such as Johnson and Johnson's problems with children's medicines (see, for example, "Unsafe Drugs: Is It Counterfeiters or the Supply Chain That's the Problem?").
These problems may be glitches in an otherwise safe drug supply chain, but did you know that up to 80 percent of the active ingredients in drugs used in the United States are made overseas? Hopefully, those ingredients meet high standards. Yet up to 149 Americans died in 2007 and 2008 after taking heparin, a blood thinner, contaminated during the manufacturing process in China.
What's often not mentioned, however, are the "inactive" ingredients in the pills we take. Viagra, for example, contains the following inactive ingredients:

  • microcrystalline cellulose
  • anhydrous dibasic calcium phosphate
  • croscarmellose sodium
  • magnesium stearate
  • hypromellose
  • titanium dioxide
  • lactose
  • triacetin
  • FD & C Blue #2 aluminum lake
Patients are warned to discontinue taking medicines if they are allergic to any of the ingredients.
These ingredients are the "pink slime" of the drug industry. But whereas "pink slime" only constitutes a small percentage of ground beef, these "inactive" ingredients comprise the bulk of the pill's weight and volume.  AND they are probably made overseas with very little FDA supervision.
One of these ingredients may be as controversial to patients as "pink slime" is to hamburger eaters. In fact, this was the case with Johnson and Johnson's baby shampoo that consumers learned contained cancer-causing chemicals. That issue was big on social media for a while until J&J promised to phase out the product in the U.S. (it has been completely pulled from the shelves in other countries).
The food industry is blaming "misinformation" amplified via social media as the main cause of the consumer backlash against "pink slime." They have launched a two-pronged campaign to deal with the crisis: (1) issue "corrective" information, and (2) warn of higher prices if "pink slime" is no longer used in hamburger meat.
This sounds similar read more..