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http://www.nytimes.com/2009/11/16/business/16drugprices.html
http://www.nytimes.com/2009/11/17/business/economy/17econ.html
But when it ran an article on auto sales rebounding (see above) it failed to mention this which was on the AP.....
As auto sales rebound, price increases are likely
Written by Associated Press | | news@toledofreepress.comWhen Rebbie Lewis McGowen decided to replace her 2000 Dodge Stratus sedan with a new loaded-out Jeep Grand Cherokee, she was amazed that her favorite dealer agreed to a price that was about the same as she paid for a similar Jeep nine years earlier.
“That’s why I jumped on it the first day I saw it,” said McGowen, 61, who got the silver sport utility vehicle from River Oaks Chrysler Jeep in Houston for about $34,000, $7,000 less than the sticker price.
Like many U.S. buyers, she took advantage of a depressed auto industry, one that in recent years has had too many factories churning out too many cars and trucks for too few buyers, forcing big discounts. Although sticker prices have risen, actual sales prices aren’t a whole lot different than they were nine years ago.
So far this year, average sale prices actually have dropped by about $800 to $25,586, according to J.D. Power and Associates.
But industry analysts don’t expect that trend to continue much longer. General Motors Co. and Chrysler Group LLC came out of bankruptcy protection with far fewer factories, and Ford Motor Co. for the past few years has been closing plants to align its output with demand.
Analysts say that with the industry’s massive restructuring, the big discounts that American consumers have gotten used to could go away as auto sales recover from the worst slump in more than a quarter-century.
“I just think it happened to be this point in time that I was able to make such a deal,” McGowen said. “Next year, when the 2010s come out, it’s not going to be the same situation.”
Growth in rebates, low-interest loans and other incentives may be starting to slow, reports the Edmunds.com automotive Web site. Across the industry, the average incentive per vehicle dropped from $2,869 in June to $2,735 in July.
But that could be an anomaly driven by increased demand from the government’s Cash for Clunkers program, which likely will expire in September. July’s figure is still $90 higher than the same month last year, according to Edmunds.
In addition to the restructuring, all of the Detroit Three are trying to develop better cars, ones that are so stylish, efficient, safe and reliable that people will pay more for them, similar to what Toyota Motor Co. and Honda have already accomplished in the U.S. market.
At Ford, the only one of the Detroit Three to evade bankruptcy court, getting more money per car is part of a strategy to return to profitability, Chief Financial Officer Lewis Booth said recently.
“We’ve all got to learn to flex the revenue muscle,” said Booth, who adds that Ford’s actual sale prices are up this year, even in a down market. “It’s driven by our new products, and that’s why were getting improved transaction prices. We’re getting a mixture of reduced incentives and higher value from the customer. We’re selling more higher-service cars, more options, and all of those are good for profits and revenue.”
Now that people are demanding we reimport drugs to reduce prices, why don't they be consistent and demand importation of cheap cars from China and India...?
According to Evan Tracey (Campaign Media Analysis Group, a group that tracks political advertising), those opposed to the healthcare bill passed by the House (led by the U.S. Chamber of Commerce)have spent $24 million on TV commercials over the past month to $12 million spent by those who support the legislation (led by Healthcare for America Now and Moveon.org) This is a reversal from the previous spending advantage by bill supporters enjoyed through most of this year.
Why? Consider that Senate Majority Leader Harry Reid (D, NV) is drafting the Senate’s version of the bill behind closed doors.
"There's no input from any of us, no input from Republicans" said R. Bruce Josten of the U.S. Chamber of Commerce. "So what option do we have than to take our message and story to the American people?"
And the American people need to hear all sides of the argument. According to a new Associated Press poll, 43 percent of Americans oppose the health care plans being discussed in Congress, while 41 percent are in support. An additional 15 percent remain neutral or undecided.
Peter Pitts Talks with Pixels and Pills at the FDA Hearings from Zemoga on Vimeo.
Bob Goldberg on America's Nightly Scoreboard (Fox Business News) from CMPI on Vimeo.
She’s absolutely right. No matter which proposal you look at in either the House or Senate, young Americans will get a raw deal.
CMPI recently interviewed Congressman Aaron Schock – the youngest member of Congress at age 28. We asked him about this issue and more.
Schock is optimistic that young Americans will come to recognize that the current proposals under consideration in Congress will lead to less choices and control for them in health care, not more.
Perhaps more importantly, Congressman Schock correctly notes the deleterious effect this legislation would have on an already precarious job market.
It amounts to a double whammy for America’s youth.
For Congressman Schock’s perspective on this issue, watch our interview with him here:
Congressman Aaron Schock (R,IL) on Health Care reform from CMPI on Vimeo.
As a reminder, the four criteria for an actionable adverse event are: (1) identifiable patient, (2) identifiable reporter, (3) specific use of a drug or biologic, and (4) adverse event.
During the course of the day, there were many graphics showing an ostrich with his head in the sand and another part of the anatomy sticking up, fully exposed, in the air.
Here’s what I had to say on the matter during my remarks on Day 1:
Adverse event generation is the real bête noire of social media. Should companies actively avoid participation – even to the degree of monitoring – lest they uncover an adverse experience? Shouldn’t companies embrace social media so that adverse experiences can be found with greater alacrity? Shouldn’t companies be rewarded for such behavior? If regulated industry wants the FDA to be both regulator and colleague, then it’s not a leap of faith to imagine that the FDA would like industry to be proactive in its search for new ways to surface adverse events.
I know of one large pharmaceutical company whose policy is not to monitor social media sites because they don’t want to unearth adverse events. Is this responsible? Is it even supportable? If this company received a call from a reporter and was asked if they purposely avoid social media so as not to find adverse experiences, would the truth set them free? Legally they may be in compliance, but it wouldn’t look good on Page One or sound very good in front of a congressional subcommittee. “In compliance” and “in the best interest of the public health” must not be mutually exclusive propositions.
Day 2 began with Boston Scientific’s Tony Blank (again representing AdvaMed) saying that industry expects to be held responsible for the responsible reporting of adverse events and for user-generated content (UGC) when it is sought for/requested by a regulated healthcare company – an important finesse. He raised the dicey issue of anonymous AE reports, ending his comments with the question, “How can we separate the wheat from the chaff?” How indeed?
Next was private citizen Kim Witczak, who called for the FDA to make the MedWatch program more accessible and user-friendly (a theme repeated during the course of the proceedings) and that proactive monitoring of social media by industry should be viewed as a “responsible act” – another oft-repeated theme.
Steve Findlay (Consumer’s Union) said that the current AERS is “a glass half full” and suggested that there’s a real need for better early safety signal communications mechanisms. He proposed that a prominent and consumer-friendly AE reporting tool be a part of all industry marketing and communications efforts (both online and otherwise). He went even further, suggesting that similar efforts be required of third parties who receive industry funding. He referred to a “voluntary burden,” but went on to use words like “mandatory.” Later on in the day, he also called for the FDA to “investigate” industry’s use of web optimization – and that FDA’s oversight of social media should be funded by user-fees.
This last point brings up an important issue – what parts of social media can/should FDA regulate? The FD&C Act is pretty specific (and the First Amendment is pretty important) and (at least in my opinion) this will lead to relatively narrow agency guidance (when it comes). This will surely be a crucial point of discussion in the weeks and months ahead.
Is social media really the place patients are taking their adverse event discussions?
Chris Schroeder (HealthCentral) shared new research showing that patients experiencing an adverse event would chose to (1) call their doctor (89%), (2) share their issue on a social media site (2%), (3) contact the FDA (1%). Chris also made the point that, in future guidance, FDA should define what “sponsor” means in the context of an industry “sponsored” Internet or social media site. He also observed that online ads adjacent to user-generated content shouldn’t lead to an advertiser being responsible for that UGC – just as ads on television programs (particularly live ones) aren’t responsible for the content of the programming.
Shaleen Gupta (Semantelli Corporation) introduced a new disease state – FOFDA (“Fear of FDA”). He opined that, per AE reporting and social media, that we need to use technology to help “go beyond the noise.” This issue came up more than a few times – how to address the signal-to-noise ration. (Other speakers referred to this problem as “data smog.”
Jeff Francer (PhRMA) commented that AE reports uncovered via social media need to be addressed not via public response but through private communications --generating some interesting questions from the FDA panel as to how this could be done.
Rohit Bhargava (Ogilvy 360 Digital Influence) made the point that most AEs (broadly defined) on social media are anonymous. Therefore they are not (technically) adverse events. A statement of the obvious and a narrow view of a significant public health problem/opportunity.
Rick Wion (GolinHarris) shared that one such client page (with the interactivity switched “on”) generated only one comment out of 400 addressed could be considered a negative product experience (and not even, technically, an adverse event).
Speaking of FaceBook, I believe the FDA should create a social media adverse event FaceBook page that people can “friend” in order to learn more about how to report “official” adverse events and through which the agency can push out important safety alerts and other important risk information. After all, as Arnie Friede pointed out in his remarks, MedWatch only captures about 10% of all adverse events.
Side note: Many (if not most) of the 69 people who testified over the two-day hearing were not FDA experts, leading to some pretty wild suggestions (such as the call for an “intergalactic social media taskforce”) but also some new and exciting ones. It was clear (from both questions and body language) that the FDA panel was both unaccustomed and uncomfortable being regularly and aggressively challenged – like Anna challenging the King of Siam. “Is a puzzlement” was often written across the faces of the distinguished panel.
This “puzzlement” was particularly evident in the questions posed to multiple presenters by Gerald Del Pan (FDA’s Director of the Office of Surveillance and Epidemiology, CDER). Dr. Del Pan seemed perplexed that presenters wanted to talk more about communicating to patients than about outreach to physicians. And while that may sound narrow-minded, it needs to be understood in the appropriate regulatory context. Del Pan’s questions represent an appropriate understanding as to the regulatory limitations of what the FDA can do. This is very important, because it will significantly impact the range and depth of future FDA social media guidance. And that’s a good thing.
Per the low incidence of adverse event reporting, James Allen Heywood (PatientsLikeMe) asked, “What’s the value to a patient for reporting an adverse event?” Good question. Later on he made another important (and frightening) observation, “There is no longer an authoritative voice of authoritative information.” This statement caused the FDA panel to shift uncomfortably in their seats – but elicited no questions.
Diana Zuckerman (National Research Center for Women & Families) made that point that while AE reports are “anecdotal” and clinical trials are “scientific -- both are important. And she’s right – particularly since AEs are a valuable source of post-market early safety signals. Finally she said that links to MedWatch should be “hard to miss rather than hard to find.” Certainly.
John Mack (Pharma Marketing News) shared research showing that only 1 out of 500 AEs on social media meet all four adverse event criteria.
Paul Roellig (Bulletin News) suggested that any forthcoming FDA regulations should be “technology neutral” so as not to give any one platform an unfair advantage. Specifically, he was referring to e-mail based versus online platforms.
Daniel Palestrant (Sermo) observed that on the physician-only site, participant ability to discern hyperbole is “uncanny.” An example of social media’s ability to self-correct? Maybe.
Donna Wray (TGaS Advisors) cautioned industry on commenting on every social media site, citing “the danger of giving crazy talk validity.” Sound advice. But “crazy” is certainly in the eye of the beholder.
Jonathan Richman (Dose of Digital) commented that “Community Norms” are not the same as “Regulated Norms” – another nod to the reality (both legal and otherwise) that FDA can only hope to impact a small part of a much larger issue.
Fabio Gratton (Ignite Health) shared data showing that only 27% of consumer who visit a brand.com site access safety information. Of that 27%, 32% find the site via a paid search, 19% access the site directly, and 10% find the brand site via a search engine. The important take-away is that paid search options lead to more use of safety data. The more direct public health point is that the FDA’s bevy of sponsored Google link NOVs (and the resulting decline in consumer clicks on them) has actually led to less consumer use of on-line risk information. A dangerous unintended consequence.
Relative to industry oversight of the Internet, Robert Grammatica (Rapp) asked, “To whom should manufacturers be responsible? His answer, “to the patient.” Amen. He also mentioned that social media sites that succeed are those that are designed to do more than just sell product. Common sense but not common enough practice.
Jim Walker (Cadient Group) talked about the importance of social media as a tool to enhance health literacy and suggested that the FDA offer a kind of “X Prize” to those who can develop ways to achieve this laudable goal. Well – maybe not FDA. Secretary Sebelius – are you listening?
Wendy Blackburn (Intouch Solutions) shared research demonstrating that the more prominent safety information is on a brand.com site, the greater the “bounce” rate. (“Bounce rate” is the rate at which a visitor to a site leaves that site.) Frightening.
The final presentation of the day was by the Pfizer duo of Freda Lewis-Hall and Cliff Thumma. They presented research on using social media to communicate with physicians (example: 64% of physicians have smart phone and 81% will have them by 2012). They ended their remarks with an appropriate end-of-hearing comment to “sustain the momentum.”
And so, at 5pm – right on time – DDMAC Director Tom Abrams returned to the podium, released a big sigh and said, “Wow. We made it.”
Well, not quite yet. Not by a mile. Having held the Super Bowl of Part 15 hearings, while a memorable accomplishment, isn’t the end. Nor is it the beginning of the end. And, no, it’s not even the end of the beginning. It was just the end of the day.
CONCLUSIONS
Where will this all lead? Abrams said, “We have much work to do … and it’s too important not to do it right.” Certainly. But it’s not an excuse to do nothing – the fear of many in the room and in the healthcare industry.
The FDA docket closes in February. After that, DDMAC will review all the materials – and there will be a lot of material to be reviewed by a pretty spare DDMAC staff. That will take time. Then the FDA will have to decide what – if anything – it want to do. And that also will take time.
So what will we see and when will we see it?
Don’t hold your breath. FDA operates in FDA time (“the time it takes to get it right”) -- almost the opposite of social media time (immediate gratification).
My prediction – a guidance sometime in late 2010 or early 2011 that focuses on three issues: (1) the range of adverse event reporting responsibility (not a redefinition of what an adverse event is), (2) ways to make MedWatch more visible (even to the degree of mandating prominent display of a MedWatch icon on print and broadcast advertising, promotional materials and, obviously, online) and, (3) the creation of “safe harbor” parameters to allow (and, hopefully, encourage) regulated industry to correct misinformation on the Internet.
Aaron Burr said, “Never do today what you can put off till tomorrow. Delay may give clearer light as to what is best to be done.”
But things didn’t turn out so good for Mr. Burr.
Better for the FDA to heed the words of Benjamin Franklin, “You may delay, but time will not.”
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
