Last week I reported that AstraZeneca (AZ) posted an ad for CRESTOR on its "AZ Health Connections" corporate blog (see "AstraZeneca's Timely CRESTOR Branded Blog Post: Did It Violate Its Own Policy?"). The post included the indication for CRESTOR and also the "Important Safety Information" (ISI) that is required by the FDA whenever a drug company talks about a brand and its approved indication.
I wrote about that only because it was the first time -- to my knowledge -- that a pharma corporate blog promoted a branded product and I wondered if such posts violated AZ's own posting policies (turns out that it may or may not depending upon what you mean by "may" -- see the post for details).
Today, I noticed an AZ Health Connections blog post that talked about another AZ drug - ARIMIDEX, which is approved for "adjuvant treatment (treatment following surgery with or without radiation) of postmenopausal women with hormone receptor-positive early breast cancer."
This time, however, the post (find it here; see screen capture above) did NOT mention the approved indication. It is, by FDA definition, a "reminder ad." According to the Pharma Marketing Network Glossary:
Reminder advertisements are identified as an exemption to the advertisement regulations, including provisions to provide a brief summary. Reminder advertisements " . . . call attention to the name of the drug product but do not include indications or dosage recommendations for use of the drug product. . . . and, optionally, information . . . containing no representation or suggestion relating to the advertised drug product." Reminder advertisements cannot make a representation about the product or suggest a use for the product.The AZ Health Connections post does "call attention to the name of the drug," but it also directs readers to ARIMIDEX Direct, which is a program that "allows eligible patients to receive ARIMIDEX delivered to their homes for $40 a month, including shipping and handling." Sounds like a good deal, although I did not investigate what the eligibility requirements were.
AZ deserves credit for reaching out to the online community to learn more about how it can make its drugs more accessible. Recall that AZ was the first pharma company to host a Twitter chat "to raise awareness about helping patients save money through prescription savings programs" (see "OMG! AstraZeneca Hosts Twitter Chat & World Does NOT End!").
PhRMA "forbids" Reminder Ads, But Not on Internet!
AZ's post raises some interesting questions regarding the promotion of Rx drugs on the Internet that neither the FDA nor the pharma industry has addressed. For example, PhRMA's "Guiding Principles for Direct-to-Consumer Advertising" (here) prohibit reminder ads on TV but NOT on the Internet:
Principle #10: "DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised." [Alos see "Reminder Ads - Pharma's Dodo?"]AZ, I believe, is a signatory to these voluntary guidelines. Since these guidelines only apply to TV advertising, AZ is not in violation. It's still the "wild west" on the Internet with regard to reminder ads; i.e., It's perfectly fine to run "reminder ads" on the Internet. This is usually the case when pharma companies buy Adwords (paid search ads) from Google, especially after the FDA came down on Adwords that included the indication with the brand name.
Another interesting issue is how pharma companies can manipulate "natural" (aka "organic") Google search results to display what is essentially a branded product ad that includes the brand name and indication, but no ISI.
Search Google for "arimidex" as I just did and you will find this:
The #4 (or #3, depending on how you count) search result leads you to the home page of the www.arimidex.com Web site. Note that the search result looks like an read more..
Monday, 4 June 2012
Health Connections-Corporate Blog-Search Result-Breast Cancer-Drug Product
Wednesday, 16 May 2012
Chief Executive-Dual Agency-Astrazeneca
Troubled drugs giant AstraZeneca calls in dual agency support
The UK’s second largest drug manufacturer is understood to have called in Tonic Life and Red Door Communications for its first UK list, following a seven-month procurement process.
However, industry insiders have questioned whether the contracts will last, given the news regarding job cuts and the chief executive’s departure, which came just days after the roster was confirmed.
A source said: ‘The future of AstraZeneca’s UK marketing operation is unclear. The whole exercise could be redundant.’
AstraZeneca would not comment on these claims, and said the agency shift comes as part of regular reviews of supplier relationships.
Simon Moore, the firm’s UK corporate comms director, said there were ‘no plans to change the UK comms team’ but would not be drawn on whether the firm’s global PR suppliers were to be reviewed.
He added: ‘The announcement in February regarding potential role reductions was part of an ongoing global restructuring programme. The potential impact for any particular geography is not confirmed at this stage, but this is not a factor in the way we manage our UK PR agencies.’
AstraZeneca, which is grappling with rising drug development costs, suffered a 19 per cent fall in profits in the period from January to March of this year.
Chief executive David Brennan is standing down in June without a permanent replacement appointed.
http://www.prweek.com/uk/news/1131763/troubled-drugs-giant-astrazeneca-calls-dual-agency-support/? read more..
Monday, 14 May 2012
Cholesterol Levels-Health Connections-High Cholesterol-Corporate Blog-Astrazeneca
It's unusual for a pharmaceutical company to mention a product by brand name on its corporate blog. But AstraZeneca (AZ) has done just that on its "AZ Health Connections" corporate blog. The majority of the post "New CDC data shows drop in number of adults with high cholesterol" submitted by Tom Hushen, AZ's External Communications Manager, talks about CRESTOR, AZ's anti-cholesterol drug. The post may have been ghostwritten for "Dr Philip de Vane, Executive Director of Clinical Development at AstraZeneca," whose name appears at the bottom.
After briefly citing the results of the CDC (Centers for Disease Control) study (see below) in the first paragraph, Hushen dedicates the most of the remaining 309 words of the 377-word post to CRESTOR as in:
"AstraZeneca applauds this progress and we are proud that when diet and exercise alone aren’t enough, prescription medications like CRESTOR® (rosuvastatin calcium) are able to help patients reach their cholesterol goals. In adults, CRESTOR is prescribed along with diet to lower high cholesterol and to slow the buildup of plaque in arteries."Included in the post is the "fair balance" information required by law:
"CRESTOR is not right for everyone-like people with liver disease or women who are nursing, pregnant or may become pregnant. Tell your doctor about other medicines you are taking. Call your doctor right away if you have muscle pain or weakness; feel unusually tired; have loss of appetite, upper belly pain, dark urine, or yellowing of skin or eyes-these could be signs of rare but serious side effects. See www.CRESTOR.com"Although this is not earth-shaking or in violation of any law that I know of, it nevertheless is the FIRST time a pharmaceutical company has promoted a prescription drug on its official corporate blog. It's even more interesting considering the AZ Health Connections "Comment Policy" seems to preclude any comments about specific products:
"We want to make sure AZ Health Connections provides a good experience for all visitors. Therefore, we want to keep the content focused on the specific topics being addressed. Comments that don’t directly relate to AstraZeneca or the topics currently being discussed, or comments or questions about specific products (whether or not AstraZeneca products) or ongoing legal or regulatory matters may not be published or may be removed."Could it be that what's good for the "goose" (AZ) is not good for the "gander" (everyone else)? It seems that AZ has relaxed its comments policy, at least this one time. As proof of this, I submitted the following comment, which AZ published:
"I am one of those U.S. adults with high cholesterol that is having problems controlling it with just diet and exercise, which I don’t even try to do :-). But I am worried about taking powerful medicines such as CRESTOR because of the side effects that you mention."AZ published that comment made by this "gander." It is the only comment published so far, so I have no idea if other people have submitted comments that were NOT published. Maybe Tony Jewell, Senior Director of External Communications at AstraZeneca US, will tell us. NOTE: Jewel received the coveted "Pharmaguy Social Media Pioneer Award" in 2011 (see here).
Note: In a personal email, Jewell said: "This post was reviewed, as are all others that mention medicines or disease states. There have been many on the blog, Twitter and Facebook." Also see his comment to this post.
Why did AZ do this at this time? It seems to be very opportunistic considering that it coincides with the release of CDC data that shows improvement to cholesterol levels for many Americans. Also, Pfizer just announced it is no longer promoting Lipitor (see "Pfizer Throws In the Lipitor Marketing Towel" and "Lipitor R.I.P. Infographic").
Obviously, now is a good time for AZ to ramp up the promotion of CRESTOR, as it is positioned to take over the number one (or virtually ONLY) statin TOP sales spot ( read more..
Sunday, 13 May 2012
Pharmaceutical Companies-Research And Development-Pharmaceutical Company-Direct Marketing
Big pharmaceutical companies are drastically cutting back on research and development. The economics just do not support the model that has been the driving force of the drug industry over the past 15 years.
According to a Forbes analysis reported by Matthew Herper, "The average drug developed by a major pharmaceutical company costs at least $4 billion, and it can be as much as $11 billion" (see "The Truly Staggering Cost Of Inventing New Drugs").
Some pundits suggest that lowering the cost of performing clinical trials will help get more drugs to market faster. Andrew von Eschenbach, former FDA Commissioner and now employed as chairman of conservative think tank Manhattan Institute's Project FDA initiative, suggested that instead of the FDA asking pharma companies to complete "laborious clinical trials proving efficacy, after proof of concept and safety testing, the product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies" (see here).
However, Herper points out that the "main expense is failure. AstraZeneca (AZ) does badly by this measure because it has had so few new drugs hit the market." AZ spent about $59 billion on R&D between 1997 and 2011, but only managed to get 5 new drugs approved. According to simple arithmetic, that means each of these 5 drugs cost about $11.8 billion to develop.
That's an interesting number. A very similar number came up during last night's 60 Minutes segment on "Treating Depression: Is there a placebo effect?" (see it here). It turns out that antidepressants sales in the U.S. bring in $11.3 billion a year to pharmaceutical companies that sell them -- including AstraZeneca!
Could it be that the drug industry is merely "breaking even" in the anti-depressant market?
I suspect they are probably making a pretty good profit -- but that profit may be diminishing as more and more anti-depressants go off patent. In fact, it has been suggested that 60 Minutes dared to air this expose -- four years after the research was first published -- because the "news" can no longer harm the drug companies that CBS depends upon for advertising -- most of the drugs mentioned are off patent (see “You’re telling me this now?” Why the news is suddenly critical of statins and antidepressants).
I did a blog post about antidepressants and the placebo effect two years ago in January 2010 (read "A Common Goal of Research and Marketing: Fool the Doctor"). In that post, it was noted that clinical evidence suggests these drugs are not any more effective than a placebo in patients with less severe depression. But drug company marketing to physicians does not mention this. Thus, physicians are led to believe that the drugs ARE effective for all patients with depression.
As pointed out in the 60 Minutes piece, "a clinician who cares, who takes the time, who listens to you, who asks questions about your condition and pays attention to what you say, that's the kind of care that can help facilitate a placebo effect." That goes double if the clinician actually believes what he or she is prescribing is a drug with proven efficacy.
Consequently, marketing to physicians along with direct marketing to consumers can play a huge role in "facilitating" a placebo effect. Which leads me to this idea: pharmaceutical companies should be in the business of developing placebos rather than dangerous, ineffective chemical compounds. There would be no need for expensive clinical trials and it would be easy for FDA to adopt von Eschenbach's idea to approve these new "drugs" before they are proven effective. It will be up to marketing to make them effective by facilitating the placebo effect!
Of course, to be successful, this new approach to drug development must be done surreptitiously and the FDA must conspire with the drug industry (not too much of a stretch there). After all, if everyone kn read more..
Tuesday, 10 April 2012
Preliminary Injunction-Patent Expiration-Astrazeneca-Seroquel-Company
AstraZeneca's ($AZN) last-ditch effort to hold off generic Seroquel has failed. A U.S. judge denied the drugmaker's request for a preliminary injunction that would delay copycat rivals, saying the company didn't prove that it qualified.The company had aimed to keep the Seroquel market to itself until December. That's when exclusivity expires on safety data that, AstraZeneca argued, should be included in any generic drug label. The company sued the FDA over the labeling issue, after the agency denied its internal request.So, as the Seroquel patent expires today, generic versions will roll onto the market. Several billion in annual sales are up for grabs; Leerink Swann's Seamus Fernandez sees a dropoff of $3.9 billion in the first 9 months of generic competition. And as the Wall Street Journal points out, Seroquel's patent expiration is just the first of three biggies over the next 5 years."This is a company that is probably facing one of the worst patent cliffs in the industry," Morningstar analyst Damien Conover told the Delaware News Journal. "That, coupled with a pipeline that hasn't produced enough offsetting new products, has really put the company in a challenging spot."AstraZeneca says it's weighing its options in the FDA lawsuit. Meanwhile, it's cutting costs, pushing hard to boost sales of existing drugs, looking for strategic acquisitions and scrambling to develop new drugs, an effort that has hit some big snags recently. Despite CEO David Brennan's repeated assurances to the contrary, analysts are playing name-that-potential-AstraZeneca-buyout, tagging such companies as Shire and Amylin Pharmaceuticals as likely prospects. But spokesman Tony Jewell says AstraZeneca will succeed by sticking to the knitting it has already begun: "We knew this was coming, and we have a business strategy," Jewell told the News Journal.- read the News Journal piece
- get more from the WSJRelated Articles:
AstraZeneca sues FDA to block Seroquel copies
With Seroquel petition denied, AZ needs M&A
Is AZ aiming for a Forest buy? read more..
Sunday, 8 April 2012
Cholesterol Level-Bionic Legs-Astrazeneca-Doctor
via uk.reuters.com By Ben Hirschler and Sinead Cruise Posted via email from Jack's posterous read more..
Bionic legs helps the user walk up steps, up or down slopes
New Zealand-based Rex Bionics sells bionic legs, which can be used by people with paralysed limbs to walk. (Source: The Economic Times Healthcare and Biotech News) read more..
Aztor 10 should i continue or not
Iam was taking aztor 10 for 2 years daily as prescribed by my cardiologist.The Doctor advised me to continue taking Aztor 10 through out. He also advised me for 4 kms walk ever day.
I started parcticising Suryanamaskaram & Practiced yoga and lost 7 kg body weight though iam not overweight and my LDL and Total Cholesterol is within the limits. I stopped taking Aztor 10. will my Cholesterol level increase. should i continue Aztor 10 even if my Cholesterol level and LDL is in control - 12 Replies read more..
Tuesday, 27 March 2012
'Tis The Season-David Brennan-Astrazeneca-Seroquel
'Tis the season for executive pay raises, and AstraZeneca's ($AZN) David Brennan is no exception. Last year, Brennan won an 11% increase in overall compensation to £3.37 million, from £3 million in 2010, the Financial Times reports. For those of us who think in dollars, that's $5.89 million and $4.77 million, respectively.The FT makes the point that Brennan's raise comes at a challenging time for AstraZeneca, with Seroquel's patent expiring today and three more significant expirations over the next 5 years (see our Seroquel story for more). It has also seen some R&D disappointments recently, dismaying investors who were hoping that a few late-stage drugs could jump into the patent-cliff gap.But stacking up Brennan's pay alongside his Big Pharma brethren, $5.89 million comes in toward the bottom. U.K. rival GlaxoSmithKline's ($GSK) boss got a 24% raise to £6.7 million, or $10.5 million, while Bristol-Myers Squibb ($BMY) chief Lamberto Andreotti clocked a 27% increase to almost $15 million. It can certainly be argued that these companies have better short-term prospects than AstraZeneca does, particularly Bristol-Myers, which has an impressive recent record on the R&D side. But the fact remains that Brennan is far from the highest paid pharma exec out there--and given AstraZeneca's current problems, that raise could be considered hazard pay.- read the FT story?Related Articles:
With patent running out, AZ loses bid to block Seroquel copies
Abbott execs take pay cuts, but White still nabs $24M
J&J's Weldon due for $143M retirement package
After big hike in 2011, GSK CEO's pay set to jump again read more..
Sunday, 11 March 2012
Antipsychotic Drug Seroquel-Astrazeneca
The FDA has officially denied AstraZeneca's petition to hold off generic versions of its antipsychotic drug Seroquel. The agency turned down AZ's ($AZN) request that it withhold final approval of any knockoff version that didn't bear the same safety warnings as the branded drug. Seroquel is expected to face generic competition after the company's pediatric exclusivity expires later this month.Credit AstraZeneca for trying: Seroquel is a multibillion-dollar drug, and watching those sales erode will be painful for the drugmaker. Indeed, the FDA's decision only underscores how needy AstraZeneca soon will be. The company has announced another big round of cost cuts, but cutting can't continue forever. Analysts are expecting the company to go on an acquisition spree, to make up for the fact that its internal pipeline has offered up several disappointments lately.And apparently, the company has the same idea. Research chief Martin Mackay told Reuters that AZ is "actively talking to a number of companies," both biotech prospects and "peer-to-peer" opportunities. "I will be disappointed if we do not do some deals this year that the market will be pleased by," Mackay said.Bernstein's Tim Anderson listed a few prospects, as the Philadelphia Inquirer reports: Amylin Pharmaceuticals ($AMLN), which recently won approval for its long-lasting version of the diabetes drug Byetta, a deal that could run $4.5 billion. Shire, the growing U.K. drugmaker, a much bigger deal at $30 billion. Or Abbott Laboratories' ($ABT) soon-to-be-split-off drug business at $52 billion. But he figures that sub-$10 billion deals are most likely.That would be Mackay's opinion, too. "We are looking at some in the low billions (of dollars) ... with deals of that size, we can do them sequentially and build that way," Mackay told Reuters. "We know one deal won't be the answer in itself." And CEO David Brennan (photo) has been unequivocal in his opposition to a major merger. A series of 5-6 deals, as investor Dan Mahoney of Polar Capital suggests to Reuters? We'll have to wait and see.- see AstraZeneca's press release
- get more from Dow Jones
- check out the Inquirer piece
- read the Reuters analysisRelated Articles:
AstraZeneca's plan to avoid megamergers suffers after pipeline setbacks
Can AstraZeneca continue to swear off major M&A?
AZ chief: Emerging markets are tougher than you think
AZ, GSK ask carmakers for directions amid pharma breakdown read more..