I’m at the lake doing some fishing…
I’ll check in every now and then, but postings will be slow for the next two weeks.
Enjoy the rest of the summer!
Thursday, August 30, 2007
Peter Rost Weekly Book Sales Update, Week 4
After spending most of the week outside of the top half-million books, Peter Rost’s Killer Drug exploded back into the Amazon rankings with the sales of another copy. Overall sales ranking for Killer Drug is now back up to 175,504 (up from 449,296 last week).
Petey’s first book The Whistleblower is currently ranked 91,501 (down from 48,844), but continues to hang in the top 100,000 books on Amazon.
Petey’s first book The Whistleblower is currently ranked 91,501 (down from 48,844), but continues to hang in the top 100,000 books on Amazon.
September Medical Meetings
September 9-11 – American College of Clinical Pharmacology (ACCP), 36th Annual Meeting at the Palace Hotel in San Francisco.
September 24-29 – Institute for Functional Medicine, Applying Functional Medicine in Clinical Practice at the Hyatt Regency in Bellevue, Washington.
September 26-29 – American Heart Association (AHA), 61st High Blood Pressure Research Conference 2007 at the Westin La Paloma in Tucson, Arizona.
September 27-30 – American Dental Association (ADA), Annual Session at the Moscone Center in San Francisco.
September 27-30 – American College of Nutrition (ACN), 48th Annual Meeting: Scientific Approaches for Individualized Nutrition at the Walt Disney World Resort in Orlando.
September 27-30 – American Academy of Physical Medicine and Rehabilitation (AAPMR), 68th Annual Assembly at the John B. Hynes Veterans Memorial Convention Center in Boston.
September 29-October 2 – American Dietetic Association (ADA), Food & Nutrition Conference & Expo at the Pennsylvania Convention Center in Philadelphia.
September 24-29 – Institute for Functional Medicine, Applying Functional Medicine in Clinical Practice at the Hyatt Regency in Bellevue, Washington.
September 26-29 – American Heart Association (AHA), 61st High Blood Pressure Research Conference 2007 at the Westin La Paloma in Tucson, Arizona.
September 27-30 – American Dental Association (ADA), Annual Session at the Moscone Center in San Francisco.
September 27-30 – American College of Nutrition (ACN), 48th Annual Meeting: Scientific Approaches for Individualized Nutrition at the Walt Disney World Resort in Orlando.
September 27-30 – American Academy of Physical Medicine and Rehabilitation (AAPMR), 68th Annual Assembly at the John B. Hynes Veterans Memorial Convention Center in Boston.
September 29-October 2 – American Dietetic Association (ADA), Food & Nutrition Conference & Expo at the Pennsylvania Convention Center in Philadelphia.
Maine and Vermont Physician Secrecy Laws Challenged
Maine and Vermont recently passed physician secrecy laws earlier this year (see links below) that were nearly identical to the constitutionally flawed legislation passed by New Hampshire. Rather than wait for the issue to be sorted out by the courts, the state’s forged ahead.
Yesterday, data firms IMS Health, Wolters Kluwer Health and Verispan announced that they filed challenges in both Maine and Vermont. The companies noted that the data play critical roles in drug safety and assisting in drug recalls.
In a press release e-mailed by IMS Health, Wolters Kluwer Health and Verispan, they state: “The new laws in Vermont and Maine will have the same unintended consequences as the one in New Hampshire, blocking vital healthcare information from public view while doing nothing to drive down prescription drug costs or improve the health and well-being of citizens. In fact, it’s very likely they will have the opposite effect,” said Randy Frankel, IMS vice president, External Affairs. “While we would have preferred to work with both states on alternatives, they have chosen instead to follow the same path as New Hampshire. We feel we have no choice but to protect access to this essential information by opposing any legislation of this nature.”
This is a red herring (maybe it should be called blue-state herring). Most of the legislators making these laws are counting on the American public to be too stupid to see the truth. Rather than write laws that actually address prescription drug prices, they chest pound over data laws. The legislators claim they’re doing something and they hope the public is too stupid to know the difference.
For background on Maine, see A Truckload of Healthcare Bills.
For background, see Vermont Quietly Passes Data Ban.
Yesterday, data firms IMS Health, Wolters Kluwer Health and Verispan announced that they filed challenges in both Maine and Vermont. The companies noted that the data play critical roles in drug safety and assisting in drug recalls.
In a press release e-mailed by IMS Health, Wolters Kluwer Health and Verispan, they state: “The new laws in Vermont and Maine will have the same unintended consequences as the one in New Hampshire, blocking vital healthcare information from public view while doing nothing to drive down prescription drug costs or improve the health and well-being of citizens. In fact, it’s very likely they will have the opposite effect,” said Randy Frankel, IMS vice president, External Affairs. “While we would have preferred to work with both states on alternatives, they have chosen instead to follow the same path as New Hampshire. We feel we have no choice but to protect access to this essential information by opposing any legislation of this nature.”
This is a red herring (maybe it should be called blue-state herring). Most of the legislators making these laws are counting on the American public to be too stupid to see the truth. Rather than write laws that actually address prescription drug prices, they chest pound over data laws. The legislators claim they’re doing something and they hope the public is too stupid to know the difference.
For background on Maine, see A Truckload of Healthcare Bills.
For background, see Vermont Quietly Passes Data Ban.
Monday, August 27, 2007
Another Blow to Physician Secrecy
The Wall Street Journal on Friday reported that Consumer’s CHECKBOOK/Center for the Study of Services won a lawsuit against the Department of Health and Human Services to release physician-claims data (see the Consumer’s CHECKBOOK press release). The data are issue are Medicare billing information such as details of medical procedures and billing information that physicians submit to get reimbursement for under the Medicare program. The Journal notes that, “Although collected largely for billing and administrative purposes, the data could be analyzed to see how often a doctor performs a given procedure and even to compare mortality rates among patients of different doctors.”
The WSJ states, “the federal court in the District of Columbia ruled the public interest outweighs the privacy concern.” The initial ruling covers only the District of Columbia, Illinois, Maryland, Virginia and Washington, however the group has filed information requests in all other states.
The Consumer’s CHECKBOOK group will set up a free website for consumers to use in evaluating physicians.
A couple of thoughts that make this interesting—
First, much time has been devoted recently to discussing websites that rate physicians (See Ranking Your Doctor and Physician Takes Aim at First Amendment). These doctor ranking sites include the likes of RateMDs.com, HealthGrades.com and DrScore.com. Recently, Jeff Segal at Medical Justice announced a jihad against any websites (such as these), which empower patients and provide them with information (be it factual or anecdotal) about patients’ experiences with physicians. No doubt Segal will be setting his sights on this new threat to physician dominance.
Second, you have to ask yourself why physicians are so hell bent on keeping Medicare billing secret. It’s just billing information after all. What could possibly be so threatening to a doctor in this information (it’s not like somebody is complaining that the doc has bad breath)? Well, the answer may be in a previous posting: The Truth of Medicare Spending. There are numerous stories of physicians scamming and defrauding Medicare by submitting false claims. By opening themselves up to independent evaluation, more of these doctors could be discovered. How embarrassing! And imagine if the data were actually used to evaluate how physicians perform! Physician accountability is to be avoided at all costs.
The WSJ states, “the federal court in the District of Columbia ruled the public interest outweighs the privacy concern.” The initial ruling covers only the District of Columbia, Illinois, Maryland, Virginia and Washington, however the group has filed information requests in all other states.
The Consumer’s CHECKBOOK group will set up a free website for consumers to use in evaluating physicians.
A couple of thoughts that make this interesting—
First, much time has been devoted recently to discussing websites that rate physicians (See Ranking Your Doctor and Physician Takes Aim at First Amendment). These doctor ranking sites include the likes of RateMDs.com, HealthGrades.com and DrScore.com. Recently, Jeff Segal at Medical Justice announced a jihad against any websites (such as these), which empower patients and provide them with information (be it factual or anecdotal) about patients’ experiences with physicians. No doubt Segal will be setting his sights on this new threat to physician dominance.
Second, you have to ask yourself why physicians are so hell bent on keeping Medicare billing secret. It’s just billing information after all. What could possibly be so threatening to a doctor in this information (it’s not like somebody is complaining that the doc has bad breath)? Well, the answer may be in a previous posting: The Truth of Medicare Spending. There are numerous stories of physicians scamming and defrauding Medicare by submitting false claims. By opening themselves up to independent evaluation, more of these doctors could be discovered. How embarrassing! And imagine if the data were actually used to evaluate how physicians perform! Physician accountability is to be avoided at all costs.
Friday, August 24, 2007
How the Mighty Have Fallen: Johnson & Johnson
The current issue of The Strategist (the magazine of the Public Relations Society of America) contains an article entitled “Betting the Business: Preserving Your Corporation by Preserving Your Reputation.” The primary case example is Johnson & Johnson’s handling of Tylenol cyanide tainting.
However, what the author (K.C. Brown of the Cision U.S. Healthcare) could not have foreseen when he wrote the article is that it would be published at exactly the same time as J&J’s PR Implosion for suing the American Red Cross (see J&J Flushes Tylenol Goodwill and J&J’s PR Gaffe Continues). One has to wonder how many of the veterans of the Tylenol days are even left at J&J who remember how to do things properly.
Brown analyzes several other company crisis situations (Jet Blue, Kryptonite bike locks and Exxon Valdez) and compares them to the J&J’s Tylenol situation. The key lessons are:
K.C. Brown sums it up best when he says: “These examples illustrate that at times corporate reputation must come first, and PR professionals must be prepared for these occasions… You must also convince the CEO that instantaneous crisis response is essential.” Finally, he notes: “History shows that recovering a company’s good reputation can be more difficult than coming back from financial problems.” J&J has one long hill climb…
However, what the author (K.C. Brown of the Cision U.S. Healthcare) could not have foreseen when he wrote the article is that it would be published at exactly the same time as J&J’s PR Implosion for suing the American Red Cross (see J&J Flushes Tylenol Goodwill and J&J’s PR Gaffe Continues). One has to wonder how many of the veterans of the Tylenol days are even left at J&J who remember how to do things properly.
Brown analyzes several other company crisis situations (Jet Blue, Kryptonite bike locks and Exxon Valdez) and compares them to the J&J’s Tylenol situation. The key lessons are:
- Act decisively
- Be prepared
- Don’t waffle
- Be genuine
K.C. Brown sums it up best when he says: “These examples illustrate that at times corporate reputation must come first, and PR professionals must be prepared for these occasions… You must also convince the CEO that instantaneous crisis response is essential.” Finally, he notes: “History shows that recovering a company’s good reputation can be more difficult than coming back from financial problems.” J&J has one long hill climb…
Peter Rost Weekly Book Sales Update, Week 3
Overall sales for Peter Rost’s novel Killer Drug declined in its third week. Overall sales have dipped to 449,296 (down from 169,515 on August 17, 2007). Killer Drug is still hanging in the top half-million books sold by Amazon.com. The sales trend is depicted in the picture below. The book is no longer ranked on the Legal Thrillers micro-genre list of top 100 books.
An anonymous poster has requested more information on my methodology for tracking Killer Drug’s sales. It’s easy – every morning, shortly after I settle into my big chair with my large cup of coffee, I pull up the Killer Drug product listing on Amazon.com and then note the sales ranking in an Excel file. I use the raw data to populate a graph showing the trend.
Additionally, going forward, I will also be tracking sales of Petey’s first book: The Whistleblower: Confessions of a Healthcare Hitman. Current sales ranking is 48,844.
You can learn more about Peter Rost’s publisher at Soft Skull Press. Soft Skull Press is a small, independent publisher in Brooklyn, NY. The average print run for a book is about 4,000 copies. Soft Skull specializes in “out-of-the-mainstream” books (such as gay/lesbian erotica) like this one: “Bottoms Up: Writing About Sex.” The description from the website: “One girl cruises the litter-strewn docks of Long Beach disguised as a f@@ while another begs to feel her lover's butter-slick c**k slip inside her a$$. Feeling clumsily sexy in her date's presence, like ‘some kind of frankenwhore,’ another woman is tied to a child's desk and made to read from Revelations while allowing torn bits of toast to be placed on her tongue.” Quality literature!
An anonymous poster has requested more information on my methodology for tracking Killer Drug’s sales. It’s easy – every morning, shortly after I settle into my big chair with my large cup of coffee, I pull up the Killer Drug product listing on Amazon.com and then note the sales ranking in an Excel file. I use the raw data to populate a graph showing the trend.
Additionally, going forward, I will also be tracking sales of Petey’s first book: The Whistleblower: Confessions of a Healthcare Hitman. Current sales ranking is 48,844.
You can learn more about Peter Rost’s publisher at Soft Skull Press. Soft Skull Press is a small, independent publisher in Brooklyn, NY. The average print run for a book is about 4,000 copies. Soft Skull specializes in “out-of-the-mainstream” books (such as gay/lesbian erotica) like this one: “Bottoms Up: Writing About Sex.” The description from the website: “One girl cruises the litter-strewn docks of Long Beach disguised as a f@@ while another begs to feel her lover's butter-slick c**k slip inside her a$$. Feeling clumsily sexy in her date's presence, like ‘some kind of frankenwhore,’ another woman is tied to a child's desk and made to read from Revelations while allowing torn bits of toast to be placed on her tongue.” Quality literature!
Thursday, August 23, 2007
Regeneron and sanofi-aventis Advance Cancer Trials
Regeneron and sanofi-aventis have launched a Phase III trial for aflibercept. The compound is being studied in prostate and lung cancers. Aflibercept is a vascular endothelial growth factor (VEGF) Trap, inhibiting angiogenesis in new tumors.
Aflibercept will compete against Avastin (bevacizumab), the blockbuster from Genentech and Roche.
Aflibercept will compete against Avastin (bevacizumab), the blockbuster from Genentech and Roche.
[Source: Reuters]
Rogue Pharmacies
No Prescription? No Problem! So reports the Associated Press, which has been investigating the disturbing trend of narcotic drug distribution via the Internet.
According to the AP, in Appalachia, the focal point of the trend, illegal drug shipments from illegal pharmacies are so frequent that FedEx and UPS have had to add extra delivery trucks! The DEA says that 95% of internet pharmacy shipments are for controlled substances, compared to just 11% for all drug channels.
Some key quotes out of the article:
“For people addicted to prescription medications like the painkiller hydrocodone — sold mostly as Vicodin — the days of ‘doctor shopping’ are over, as long as they have Internet access. With the help of unscrupulous doctors and pharmacists, hundreds of Web sites dispense prescription narcotics to customers in exchange for nothing more than a credit card number.”
“The Web sites approach doctors, often those who are in debt or retired and are seeking extra income. The doctors write prescriptions after they review online questionnaires filled out by customers. They are usually paid between $10 and $25 for each prescription.”
But who needs rogue Internet pharmacies when you have a New Hampshire? To get around the issue of tracking drug prescriptions, New Hampshire enacted a physician secrecy ban (see Pill Mill Doctors). Blocking data from data companies (and thus their clients like pharmaceutical companies and the government) has been a primary strategy for enabling doctor shopping. No need to order off a rogue pharmacy—just find a New Hampshire physician!
Anecdotal evidence from a sampling of New Hampshire pharmacies suggests that during the data ban (the New Hampshire law was overturned in the courts), there was an up tick in narcotic usage in the state. Prior to the ban, New Hampshire was already having a serious problem with prescription drug abuse (see New Hampshire Prescription Drug Abuse).
The brainchild behind the effort was State Representative Cindy Rosenwald, who introduced the legislation on behalf of her husband, a New Hampshire physician.
According to the AP, in Appalachia, the focal point of the trend, illegal drug shipments from illegal pharmacies are so frequent that FedEx and UPS have had to add extra delivery trucks! The DEA says that 95% of internet pharmacy shipments are for controlled substances, compared to just 11% for all drug channels.
Some key quotes out of the article:
“For people addicted to prescription medications like the painkiller hydrocodone — sold mostly as Vicodin — the days of ‘doctor shopping’ are over, as long as they have Internet access. With the help of unscrupulous doctors and pharmacists, hundreds of Web sites dispense prescription narcotics to customers in exchange for nothing more than a credit card number.”
“The Web sites approach doctors, often those who are in debt or retired and are seeking extra income. The doctors write prescriptions after they review online questionnaires filled out by customers. They are usually paid between $10 and $25 for each prescription.”
But who needs rogue Internet pharmacies when you have a New Hampshire? To get around the issue of tracking drug prescriptions, New Hampshire enacted a physician secrecy ban (see Pill Mill Doctors). Blocking data from data companies (and thus their clients like pharmaceutical companies and the government) has been a primary strategy for enabling doctor shopping. No need to order off a rogue pharmacy—just find a New Hampshire physician!
Anecdotal evidence from a sampling of New Hampshire pharmacies suggests that during the data ban (the New Hampshire law was overturned in the courts), there was an up tick in narcotic usage in the state. Prior to the ban, New Hampshire was already having a serious problem with prescription drug abuse (see New Hampshire Prescription Drug Abuse).
The brainchild behind the effort was State Representative Cindy Rosenwald, who introduced the legislation on behalf of her husband, a New Hampshire physician.
Wednesday, August 22, 2007
Novartis to Punish India
Novartis is going to show its backside to India, announcing it would relocate its R&D facilities from the sub-continent to China and not invest any additional money in India, according to The Irish Times.
The decision is based on India’s decision not to recognize international intellectual property rights. Proponents of allowing countries like India to break patents have claimed that this is for AIDS medications and certain “diseases of the developing world.” However, India has decided to develop to break the patent on the Novartis’ cancer drug Glivec.
Novartis CEO Daniel Vasella is quoted in the Times as saying, “This [ruling] is not an invitation to invest in Indian research and development, which we would have done. We will invest more in countries where we have protection. It's not a punishment, it's just a question of the culture for investment. Do you buy a house if you know people will break in and sleep in your bedroom?”
While other companies have quietly been considering switching from India in recent months, Vasella’s public pronouncement will likely be played as a punishment against the country in the court of public opinion.
The decision is based on India’s decision not to recognize international intellectual property rights. Proponents of allowing countries like India to break patents have claimed that this is for AIDS medications and certain “diseases of the developing world.” However, India has decided to develop to break the patent on the Novartis’ cancer drug Glivec.
Novartis CEO Daniel Vasella is quoted in the Times as saying, “This [ruling] is not an invitation to invest in Indian research and development, which we would have done. We will invest more in countries where we have protection. It's not a punishment, it's just a question of the culture for investment. Do you buy a house if you know people will break in and sleep in your bedroom?”
While other companies have quietly been considering switching from India in recent months, Vasella’s public pronouncement will likely be played as a punishment against the country in the court of public opinion.
More Antidepressant Side Effects Revealed
We’ve all heard the litany of behaviors that are allegedly side effects of antidepressants (namely SSRIs and SNRIs): agitation, murder, anxiety, murder, violence, murder, paranoia, murder, etc. It seems there is almost no end that people will go to in blaming their behavior on something else.
So, the two new antidepressant side effects I recently discovered will no doubt be seized on by antidepressant abolitionists—
I was at the Starbucks the other day and came out to find the local sheriff and a young woman in a verbal exchange. It seems she (probably about 20-22 years old) had parked her orange Mazda in a handicap spot without a permit. The sheriff was citing her. And she says to the sheriff, “It’s not my fault. I just started taking antidepressants and I didn’t see the sign.” I couldn’t help but laugh. Evidently, she was taking legal strategy from the Christopher Pittman defense team (the kid who murdered his grandparents in South Carolina after family difficulties, but blamed it on a switch from GSK’s Paxil to Pfizer’s Zoloft). So add insensitivity, bitchiness and blindness to the list of antidepressant side effects.
The second antidepressant side effect comes from an e-mail I received two days ago from someone identifying themselves as Stacey Shire (I’m betting this is not her real name). Stacey wrote me (and probably other bloggers) about a very dangerous side effect of antidepressants – trans-sexualism and gender identity crisis. The individual claiming to be Stacey Shire indicated that he/she was originally born Stephen Shire, but began feeling “urges” at the age of 17, almost immediately after he/she began taking Pfizer’s Zoloft. Stacey wanted me to give her money to help her through the “transition.” So add trans-sexualism, begging and lack of self-respect to the list of antidepressant side effects.
I think we’ve reached the point with adverse events of prescription medications that some issues are real, and many others are clearly not. And the one’s that are not are overshadowing the ones that are real. Of the events that are real, there are many people claiming to have problems who really don’t (probably to get a payoff). I’m sure there were a handful of people with very real adverse events to Merck’s Vioxx. However, I highly doubt that millions of patients experienced these adverse events.
Abdicating responsibility for one’s actions and blaming some external force has existed for a long time. Blaming prescription drugs for an individuals’ bad decision is just one step down the road from Dan White’s Twinkies or "the devil made me do it."
So, the two new antidepressant side effects I recently discovered will no doubt be seized on by antidepressant abolitionists—
I was at the Starbucks the other day and came out to find the local sheriff and a young woman in a verbal exchange. It seems she (probably about 20-22 years old) had parked her orange Mazda in a handicap spot without a permit. The sheriff was citing her. And she says to the sheriff, “It’s not my fault. I just started taking antidepressants and I didn’t see the sign.” I couldn’t help but laugh. Evidently, she was taking legal strategy from the Christopher Pittman defense team (the kid who murdered his grandparents in South Carolina after family difficulties, but blamed it on a switch from GSK’s Paxil to Pfizer’s Zoloft). So add insensitivity, bitchiness and blindness to the list of antidepressant side effects.
The second antidepressant side effect comes from an e-mail I received two days ago from someone identifying themselves as Stacey Shire (I’m betting this is not her real name). Stacey wrote me (and probably other bloggers) about a very dangerous side effect of antidepressants – trans-sexualism and gender identity crisis. The individual claiming to be Stacey Shire indicated that he/she was originally born Stephen Shire, but began feeling “urges” at the age of 17, almost immediately after he/she began taking Pfizer’s Zoloft. Stacey wanted me to give her money to help her through the “transition.” So add trans-sexualism, begging and lack of self-respect to the list of antidepressant side effects.
I think we’ve reached the point with adverse events of prescription medications that some issues are real, and many others are clearly not. And the one’s that are not are overshadowing the ones that are real. Of the events that are real, there are many people claiming to have problems who really don’t (probably to get a payoff). I’m sure there were a handful of people with very real adverse events to Merck’s Vioxx. However, I highly doubt that millions of patients experienced these adverse events.
Abdicating responsibility for one’s actions and blaming some external force has existed for a long time. Blaming prescription drugs for an individuals’ bad decision is just one step down the road from Dan White’s Twinkies or "the devil made me do it."
Monday, August 20, 2007
Dendreon Shows Positive Results in Breast Cancer
Dendreon has reported positive results in the Journal of Clinical Oncology for its breast cancer vaccine Neuvenge. The vaccine showed signs of shrinking tumor size in women with her2/neu-positive breast cancer tumors. The results are very preliminary, but support moving the product from Phase I into Phase II.
Neuvenge is based on the same immune-mediated response technology as the company’s other vaccine, Provenge. Provenge was recently recommended for approval by an FDA advisory committee, although was only issued an approvable letter. The reasons for this action are cloaked in secrecy and under very suspicious circumstances (see Behind the Scenes of the Provenge).
Neuvenge is based on the same immune-mediated response technology as the company’s other vaccine, Provenge. Provenge was recently recommended for approval by an FDA advisory committee, although was only issued an approvable letter. The reasons for this action are cloaked in secrecy and under very suspicious circumstances (see Behind the Scenes of the Provenge).
Friday, August 17, 2007
J&J Flushes Tylenol Goodwill
From a communications perspective, this ranks up there with the worst PR disasters I've ever seen. J&J files the lawsuit against the American Red Cross, the comms team is on vacation, they allowed the ARC to paint them into a corner of the big bad pharma company, and what was J&J's reponse? Not much for the first few days.
Then, on their JNJBTW Blog, they slowly dribble out this story about Clara Barton giving them an agreement and they start telling their side story about how they really support the ARC and have given them $5 million, etc. Too late. The story is already out there. And the only way the general public would get these facts is if they knew J&J fronted the JNJBTW blog and went looking for it. None of this supporting proof points are on the J&J website.
Companies going into this put together information websites with background documents, timelines, etc. to spin their story. J&J should have been out there saying, "we took steps X, Y, and Z over time period M in order to avoid this..." J&J's comms team took bad situation and made it far, far worse.
This stands in stark contrast to the American Red Cross response. On August 8, the Red Cross put out their first press release announcing that J&J was suiting them. J&J got their statement on August 9, the next day (that was a big miss!). But on August 10, the Red Cross put out a second statement detailing their position more completely (read it here). J&J has yet to put out such a statement or providing any of the supporting points to their argument.
But perhaps I too harshly judged the J&J communications team. IF J&J Legal were running these plays completely independent of comms and comms had no knowledge of it, that’s a different story. I’d apologize to the comms team for my criticisms. Instead, I’d have to ask who’s in charge over at J&J? Who’s calling the plays? And more importantly, does anyone have a clue?
In industry polls, pharmaceuticals now rank with gun manufacturers and the tobacco industry for credibility. And with incidents like this, it is obvious why. There’s enough bad press of stuff that pharma shouldn’t be blamed for (dumb doctor decisions), that when you have incident like this, it only reaffirms public perceptions. Every other pharma company is sitting around saying two things: 1) thank god we didn’t do something stupid like this, and 2) what were they thinking?
That sound you hear is all the goodwill of Tylenol tampering incident going down the drain...
Then, on their JNJBTW Blog, they slowly dribble out this story about Clara Barton giving them an agreement and they start telling their side story about how they really support the ARC and have given them $5 million, etc. Too late. The story is already out there. And the only way the general public would get these facts is if they knew J&J fronted the JNJBTW blog and went looking for it. None of this supporting proof points are on the J&J website.
Companies going into this put together information websites with background documents, timelines, etc. to spin their story. J&J should have been out there saying, "we took steps X, Y, and Z over time period M in order to avoid this..." J&J's comms team took bad situation and made it far, far worse.
This stands in stark contrast to the American Red Cross response. On August 8, the Red Cross put out their first press release announcing that J&J was suiting them. J&J got their statement on August 9, the next day (that was a big miss!). But on August 10, the Red Cross put out a second statement detailing their position more completely (read it here). J&J has yet to put out such a statement or providing any of the supporting points to their argument.
But perhaps I too harshly judged the J&J communications team. IF J&J Legal were running these plays completely independent of comms and comms had no knowledge of it, that’s a different story. I’d apologize to the comms team for my criticisms. Instead, I’d have to ask who’s in charge over at J&J? Who’s calling the plays? And more importantly, does anyone have a clue?
In industry polls, pharmaceuticals now rank with gun manufacturers and the tobacco industry for credibility. And with incidents like this, it is obvious why. There’s enough bad press of stuff that pharma shouldn’t be blamed for (dumb doctor decisions), that when you have incident like this, it only reaffirms public perceptions. Every other pharma company is sitting around saying two things: 1) thank god we didn’t do something stupid like this, and 2) what were they thinking?
That sound you hear is all the goodwill of Tylenol tampering incident going down the drain...
Killer Drug Weekly Sales Update, Week 2
Sales for Peter Rost’s novel Killer Drug have declined again in the second week. The book is no longer ranked in the micro-genre "Legal Thrillers" (down from 76 last week). The Legal Thrillers micro-genre only contains the top 100 books.
Overall, Killer Drug is now ranked 169,515 (down from 50,619 last week). The sales trend is depicted in the picture below.
For credibility, Rost has posted a review of his book…written by his editor. So, not surprisingly, this first review (by the book’s editor) is absolutely glowing.
Overall, Killer Drug is now ranked 169,515 (down from 50,619 last week). The sales trend is depicted in the picture below.
For credibility, Rost has posted a review of his book…written by his editor. So, not surprisingly, this first review (by the book’s editor) is absolutely glowing.
Note: This is only three data points (8/10/2007 with 19,737; 8/13/2007 with 50,619 and 8/17/2007 with 169,515). To smooth out the trend line, I'll begin collecting the data on a daily basis.
Thursday, August 16, 2007
Pharma Spends $30 Billion a Year on Marketing
Is that it? The sensational headline from Bloomberg makes me wonder why pharma is spending so little to promote its drugs. This would put pharma’s marketing and advertising at about 10.9% of sales…well below what other industries spend. Many industries spend 5-9% on advertising alone and can routinely spend upwards of 15-30% when you account for all promotion. So why is pharma spending so little?
But this article has a gem of a quote from Michael Weinstein, president of The AIDS Healthcare Foundation: “People are taking things they don’t need. These ads lead to overmedication.” Thank you Dr. Weinstein.
The message from Dr. Weinstein should be clear – all AIDS patients should STOP taking their medications. Immediately. After all, antiviral drugs are DTC advertised, so it must lead to an overuse of AIDS medications.
I touched on this in Patients Reject Dr. Michael Moore. What people like Michael Weinstein are really saying is, “Healthcare and pharmaceuticals are expensive. If we ration care, we’ll spend less. I want the best medications for my constituents (i.e., AIDS patients), but you shouldn’t have those same medications for yours (cancer patients, etc.).” What Weinstein and others are trying to do is no different than what the drug companies are trying to do - exert their influence over you and your doctor to make the decisions regarding your health.
We were having this exact same debate in 1998. Becky Logan was in her 70’s and read an Associated Press article that raised the same point as Dr. Weinstein is making – DTC “ads lead to overmedication.” She stopped taking her medication and died within the month. I hope that no patients out there are dumb enough to follow Michael Weinstein’s advice.
People should take comments from self-promoting pundits like Michael Weinstein with as much skepticism as the ads from drug companies. Both are trying to influence patients. The drug companies want you to use more of their products. The pundits want you to use less. Both are playing games with your health. The drug companies are playing for profits. The pundits are playing for politics.
But this article has a gem of a quote from Michael Weinstein, president of The AIDS Healthcare Foundation: “People are taking things they don’t need. These ads lead to overmedication.” Thank you Dr. Weinstein.
The message from Dr. Weinstein should be clear – all AIDS patients should STOP taking their medications. Immediately. After all, antiviral drugs are DTC advertised, so it must lead to an overuse of AIDS medications.
I touched on this in Patients Reject Dr. Michael Moore. What people like Michael Weinstein are really saying is, “Healthcare and pharmaceuticals are expensive. If we ration care, we’ll spend less. I want the best medications for my constituents (i.e., AIDS patients), but you shouldn’t have those same medications for yours (cancer patients, etc.).” What Weinstein and others are trying to do is no different than what the drug companies are trying to do - exert their influence over you and your doctor to make the decisions regarding your health.
We were having this exact same debate in 1998. Becky Logan was in her 70’s and read an Associated Press article that raised the same point as Dr. Weinstein is making – DTC “ads lead to overmedication.” She stopped taking her medication and died within the month. I hope that no patients out there are dumb enough to follow Michael Weinstein’s advice.
People should take comments from self-promoting pundits like Michael Weinstein with as much skepticism as the ads from drug companies. Both are trying to influence patients. The drug companies want you to use more of their products. The pundits want you to use less. Both are playing games with your health. The drug companies are playing for profits. The pundits are playing for politics.
Novartis to Buy Bayer?
Rumors are flying that Novartis might buy Bayer. Bayer’s stock soared yesterday on the speculation. This is the second time that I recall the “Novartis to buy Bayer” (the first was in 2004). And it makes about as much sense now as it did then.
It would be fantastic news for Bayer, which has been ailing. But the acquisition would make little sense for Novartis.
Then again, I’ve been wrong before. Who would have thought AstraZeneca would buy MedImmune for $15 billion (see AstraZeneca buys MedImmune, huh?)?
It would be fantastic news for Bayer, which has been ailing. But the acquisition would make little sense for Novartis.
Then again, I’ve been wrong before. Who would have thought AstraZeneca would buy MedImmune for $15 billion (see AstraZeneca buys MedImmune, huh?)?
Amgen Accepts Reality
The company announced yesterday it would cut 12-14% of its workforce, or about 3,000 positions. The company, and its headstrong CEO, have finally accepted that the company has weaknesses. Wall Street has punished the company and its leadership with Amgen’s shares are down over 25% on the year.
The company has adjusted its full year 2007 earnings guidance down and will significantly scale back on its R&D program.
No matter how you spin it, Amgen has joined the ranks of big pharma…and now has big pharma problems.
The company has adjusted its full year 2007 earnings guidance down and will significantly scale back on its R&D program.
No matter how you spin it, Amgen has joined the ranks of big pharma…and now has big pharma problems.
Tuesday, August 14, 2007
J&J’s PR Gaffe Continues
So last week J&J decided to sue the American Red Cross over…well…the Red Cross (see Red Cross Sued by J&J?).
Last week, I sent an e-mail to Hamilton Nolan at PR Week. He writes the “PR Play of the Week” – a kind of idiocy barometer – and suggested he write on the J&J PR gaffe with the Red Cross. Well, he did one better…he wrote about it on the front page in J&J, Red Cross debate logo-use lawsuit online.
The crux of the issue is that the Red Cross is the older of the organizations and has been using the logo for a longer period of time. For it’s part, J&J claims that in 1895, the founder of the American Red Cross, Clara Barton, turned over exclusive right’s to the red cross on all health-related products. Since the American Red Cross has been selling its own products for the last two years, the billion dollar conglomerate of Johnson & Johnson has felt that the alleged agreement between itself and Clara Barton of the American Red Cross has been breached. For me, it will be interesting to see if J&J can produce a copy of said written agreement and whether the courts decide if that agreement is still valid. On the Kilmer House website, which appears to be another J&J blog, “Finally, a decade after the agreement, President Theodore Roosevelt signed legislation protecting the American Red Cross’s use of the red cross mark, but at the same time reserving the rights of Johnson & Johnson to use it too.” This gives BOTH groups the right to the logo, not just J&J alone.
But what gets me is something posted on the J&J blog, JNJBTW. To explain the PR gaffe, the J&J bloggers have said, “Our small media relations group was reduced even further by summer vacations...” I would have expected J&J to recall the comms team from their vacations (and their staff blogger) – remember, J&J initiated this, so they could have controlled the timing. This shows a serious disconnect between J&J’s legal team and the communications team. Whether or not J&J is right legally, they should have been prepared for the communications and publicity onslaught.
When most companies face a PR crisis like this, they are fully prepared with documents explaining its position. In addition to their short press release, I would have expected J&J to have been prepared with extracts of the original contract with Clara Barton/American Red Cross, a full chronology, background documents listing each product of the American Red Cross which violates the agreement, a chronology detailing each step that J&J took to try and work this out with the Red Cross before filing the lawsuit, how much money J&J has donated to the Red Cross over the years, etc.
Is this a PR disaster? Absolutely. Is this big bad pharma ganging up on the little non-profit? Sure looks that way. And J&J's position could have been communicated. If this isn't what it appears to be (the big bad pharma ganging up on the good non-profit), J&J needs to tell us why. We're waiting...
Last week, I sent an e-mail to Hamilton Nolan at PR Week. He writes the “PR Play of the Week” – a kind of idiocy barometer – and suggested he write on the J&J PR gaffe with the Red Cross. Well, he did one better…he wrote about it on the front page in J&J, Red Cross debate logo-use lawsuit online.
The crux of the issue is that the Red Cross is the older of the organizations and has been using the logo for a longer period of time. For it’s part, J&J claims that in 1895, the founder of the American Red Cross, Clara Barton, turned over exclusive right’s to the red cross on all health-related products. Since the American Red Cross has been selling its own products for the last two years, the billion dollar conglomerate of Johnson & Johnson has felt that the alleged agreement between itself and Clara Barton of the American Red Cross has been breached. For me, it will be interesting to see if J&J can produce a copy of said written agreement and whether the courts decide if that agreement is still valid. On the Kilmer House website, which appears to be another J&J blog, “Finally, a decade after the agreement, President Theodore Roosevelt signed legislation protecting the American Red Cross’s use of the red cross mark, but at the same time reserving the rights of Johnson & Johnson to use it too.” This gives BOTH groups the right to the logo, not just J&J alone.
But what gets me is something posted on the J&J blog, JNJBTW. To explain the PR gaffe, the J&J bloggers have said, “Our small media relations group was reduced even further by summer vacations...” I would have expected J&J to recall the comms team from their vacations (and their staff blogger) – remember, J&J initiated this, so they could have controlled the timing. This shows a serious disconnect between J&J’s legal team and the communications team. Whether or not J&J is right legally, they should have been prepared for the communications and publicity onslaught.
When most companies face a PR crisis like this, they are fully prepared with documents explaining its position. In addition to their short press release, I would have expected J&J to have been prepared with extracts of the original contract with Clara Barton/American Red Cross, a full chronology, background documents listing each product of the American Red Cross which violates the agreement, a chronology detailing each step that J&J took to try and work this out with the Red Cross before filing the lawsuit, how much money J&J has donated to the Red Cross over the years, etc.
Is this a PR disaster? Absolutely. Is this big bad pharma ganging up on the little non-profit? Sure looks that way. And J&J's position could have been communicated. If this isn't what it appears to be (the big bad pharma ganging up on the good non-profit), J&J needs to tell us why. We're waiting...
Monday, August 13, 2007
Roche Sells Three Products to Actavis
Roche announced today that it would be selling worldwide rights to three products to the Actavis, the Icelandic generics firm.
The products are Bezalip (a lipid metabolism regulator), Rapilysin (for acute myocardial infarctions) and Neotigason (treats psoriasis and other skin disorders). Actavis is expected to begin selling the products worldwide in 2008. Roche will continue to sell the drugs in Latin America, under a license from Actavis.
The combined sales for all products are just over $100 million. However, it allows Roche to continue focusing in oncology and other high-growth fields.
The products are Bezalip (a lipid metabolism regulator), Rapilysin (for acute myocardial infarctions) and Neotigason (treats psoriasis and other skin disorders). Actavis is expected to begin selling the products worldwide in 2008. Roche will continue to sell the drugs in Latin America, under a license from Actavis.
The combined sales for all products are just over $100 million. However, it allows Roche to continue focusing in oncology and other high-growth fields.
Killer Drug Weekly Sales Update
After all of the e-mails the last few weeks about Peter Rost’s book, I thought I’d check into it. Note: If you’re the one person in healthcare who hasn’t received an e-mail from Peter Rost telling you to go buy his book, you soon will. (I officially get more e-mail from Peter Rost than I do for fake Viagra and Cialis).
So, it’s time to start a new weekly feature here on Pharm Aid: the Killer Drug Weekly Sales Update.
On August 10, I received three e-mails from Peter. He just wanted me to know that his book is a smash hit and was ranked #24 on Amazon’s Legal Thriller list (to find the legal thrillers list, you need to drill down under books to “Mystery & Thrillers,” then select “Thrillers,” then select “Legal,” then go to the second page). According to Rost’s email, his book was also ranked “19,737 overall in book sales, only a few hours after promotional launch.”
Just three days later, Rost’s Killer Drug has fallen to #76 in the micro-genre “legal thrillers” and has slid to 50,619 overall…just three days after promotional launch!
On August 10, I received three e-mails from Peter. He just wanted me to know that his book is a smash hit and was ranked #24 on Amazon’s Legal Thriller list (to find the legal thrillers list, you need to drill down under books to “Mystery & Thrillers,” then select “Thrillers,” then select “Legal,” then go to the second page). According to Rost’s email, his book was also ranked “19,737 overall in book sales, only a few hours after promotional launch.”
Just three days later, Rost’s Killer Drug has fallen to #76 in the micro-genre “legal thrillers” and has slid to 50,619 overall…just three days after promotional launch!
China Offers Food Safety “Reward”
Beijing officials have announced a “reward” for citizens who report food safety problems, according to Reuters.
Given the hype behind the announcement, this appears to be part of the Chinese Olympic PR machine vs. a meaningful food safety measure. The announcement also indicated that local officials in areas where there are problems could also be held accountable.
No word from Beijing officials on what that reward might look like...or how they will deal with officials in areas that have problems:
Given the hype behind the announcement, this appears to be part of the Chinese Olympic PR machine vs. a meaningful food safety measure. The announcement also indicated that local officials in areas where there are problems could also be held accountable.
No word from Beijing officials on what that reward might look like...or how they will deal with officials in areas that have problems:
AvandiaGate – Less Hype, More Science and the Facts Revealed
I don’t think there is anyone who hasn’t heard that GlaxoSmithKline’s Avandia increases the risk of heart attacks. Media outlets have fanned the story so far beyond the original Dr. Nissen NEJM study that it is no longer possible to tease out fact from media hype.
Against this backdrop, a new and more comprehensive analysis of the EXACT same data has demonstrated that there may not be an increased risk with GSK’s Avandia after all. The study was published in the August 7 issue of the Annals of Internal Medicine. The study by Dr. Sanjay Kaul, cardiology professor at the University of California, Los Angeles and colleagues did not demonstrate conclusively that Avandia is associated with heart attacks.
Dr. Kaul looked at more studies than Dr. Steven E. Nissen’s original study. Evidently, Dr. Nissen excluded studies where there weren’t any heart attacks. In order words, he stacked the results by only including studies which supported his hypothesis and excluded all the studies which would not support his hypothesis, thereby ensuring he got the result he was looking for (back in my day, we had many euphemisms for this kind of work, including “intellectual dishonesty” and “sham science”). So, the big question is, why did Dr. Steven Nissen exclude studies in his meta-analysis that would have resulted in a more complete and less-biased result?
The Bloggers at Drug Wonks have asserted that Dr. Steven Nissen aspires to the job of FDA Commissioner. I don’t know about that, but everything about his “study” is more about politics and less about science. So, were the gentleman bloggers at Drug Wonks right about Dr. Nissen all along? It’s starting to look that way.
As I’ve already said in Avandia Study Fallout, everything about Dr. Nissen’s original “study” is very unorthodox. Dr. Nissen, by his own admission under examination by Patrick McHenry (R-NC), has indicated that he provided “very preliminary results” of his study to Democratic congressional staff in February, prior to peer review or submitting for publication. Why? Dr. Nissen, again by his own admission, felt that a publicity campaign via Congress was more his style. When asked directly why he didn’t report this to the regulatory agency in charge of patient safety, he replied, “That is not how it’s done.” Interesting…
Even backers of Dr. Nissen (although there seems to be fewer of them these days) have acknowledged the fact his meta-analysis study has more holes than the U.S. border with Mexico. Which leads me to ask a question—had Dr. Nissen’s “study” gone the other way and actually supported Avandia, would the methodology have been sufficient to get the study published? I suspect not. I guess we have our answer with the Dr. Kaul study, which is a better designed study (and certainly more thorough), but hasn’t received nearly the same level of media coverage.
In a HealtDay story, Dr. Nissen has defended himself by saying, “The FDA presented a more statistically powerful patient-level analysis at the advisory board meeting on rosiglitazone (Avandia). This is a far more accurate approach when you have access to patient data, which we did not. The FDA confirmed a 40 percent increase in risk, virtually identical to our findings reported in the New England Journal of Medicine. Further study-level analysis will not yield any important insights."
Unfortunately, Dr. Nissen get it wrong (again). The FDA analysis, while slightly more powerful, relied heavily on Dr. Nissen’s “research” (if you can even call it that) and the FDA analysis looked at both the serious adverse events, as well as non-serious. From what I’ve read in several sources, the FDA analysis did NOT find the same risk as Dr. Nissen’s study. Of this, Dr. Kaul said, “There was not a statistically significant difference between serious and non-serious events, which is exactly what we found. There was substantial uncertainty associated with those risk estimates. You couldn't say one way or the other whether the risk was increased or decreased. When they looked at myocardial infarction [heart attack], they did not find a statistically significant increased risk."
Perhaps this is why the FDA panel voted 20-1 to keep Avandia on the market, but felt compelled to add the black box warning given the uncertainty around the cardio risk (see And Avandia Stays…For Now).
When the term AvandiaGate was coined, it was to imply some major conspiracy on the part of GlaxoSmithKline to cover-up clinical trial results. However, as the true and full scope of AvandiaGate comes to light, we can see this for what it is.
Against this backdrop, a new and more comprehensive analysis of the EXACT same data has demonstrated that there may not be an increased risk with GSK’s Avandia after all. The study was published in the August 7 issue of the Annals of Internal Medicine. The study by Dr. Sanjay Kaul, cardiology professor at the University of California, Los Angeles and colleagues did not demonstrate conclusively that Avandia is associated with heart attacks.
Dr. Kaul looked at more studies than Dr. Steven E. Nissen’s original study. Evidently, Dr. Nissen excluded studies where there weren’t any heart attacks. In order words, he stacked the results by only including studies which supported his hypothesis and excluded all the studies which would not support his hypothesis, thereby ensuring he got the result he was looking for (back in my day, we had many euphemisms for this kind of work, including “intellectual dishonesty” and “sham science”). So, the big question is, why did Dr. Steven Nissen exclude studies in his meta-analysis that would have resulted in a more complete and less-biased result?
The Bloggers at Drug Wonks have asserted that Dr. Steven Nissen aspires to the job of FDA Commissioner. I don’t know about that, but everything about his “study” is more about politics and less about science. So, were the gentleman bloggers at Drug Wonks right about Dr. Nissen all along? It’s starting to look that way.
As I’ve already said in Avandia Study Fallout, everything about Dr. Nissen’s original “study” is very unorthodox. Dr. Nissen, by his own admission under examination by Patrick McHenry (R-NC), has indicated that he provided “very preliminary results” of his study to Democratic congressional staff in February, prior to peer review or submitting for publication. Why? Dr. Nissen, again by his own admission, felt that a publicity campaign via Congress was more his style. When asked directly why he didn’t report this to the regulatory agency in charge of patient safety, he replied, “That is not how it’s done.” Interesting…
Even backers of Dr. Nissen (although there seems to be fewer of them these days) have acknowledged the fact his meta-analysis study has more holes than the U.S. border with Mexico. Which leads me to ask a question—had Dr. Nissen’s “study” gone the other way and actually supported Avandia, would the methodology have been sufficient to get the study published? I suspect not. I guess we have our answer with the Dr. Kaul study, which is a better designed study (and certainly more thorough), but hasn’t received nearly the same level of media coverage.
In a HealtDay story, Dr. Nissen has defended himself by saying, “The FDA presented a more statistically powerful patient-level analysis at the advisory board meeting on rosiglitazone (Avandia). This is a far more accurate approach when you have access to patient data, which we did not. The FDA confirmed a 40 percent increase in risk, virtually identical to our findings reported in the New England Journal of Medicine. Further study-level analysis will not yield any important insights."
Unfortunately, Dr. Nissen get it wrong (again). The FDA analysis, while slightly more powerful, relied heavily on Dr. Nissen’s “research” (if you can even call it that) and the FDA analysis looked at both the serious adverse events, as well as non-serious. From what I’ve read in several sources, the FDA analysis did NOT find the same risk as Dr. Nissen’s study. Of this, Dr. Kaul said, “There was not a statistically significant difference between serious and non-serious events, which is exactly what we found. There was substantial uncertainty associated with those risk estimates. You couldn't say one way or the other whether the risk was increased or decreased. When they looked at myocardial infarction [heart attack], they did not find a statistically significant increased risk."
Perhaps this is why the FDA panel voted 20-1 to keep Avandia on the market, but felt compelled to add the black box warning given the uncertainty around the cardio risk (see And Avandia Stays…For Now).
When the term AvandiaGate was coined, it was to imply some major conspiracy on the part of GlaxoSmithKline to cover-up clinical trial results. However, as the true and full scope of AvandiaGate comes to light, we can see this for what it is.
The Week Ahead – August 13-19
August 16 – Food and Drug Administration, Blood Products Advisory Committee.
Friday, August 10, 2007
Compassionate Use – And A Really Tough Decision
Earlier this week, the Abigail Alliance for Better Access to Developmental Drugs lost a Court of Appeals ruling that terminally ill patients do not have a constitutional right to early access (Phase I and II) to experimental medications that have not yet been approved by the U.S. FDA. Surely this one will go all the way to the Supreme Court.
While I do think that the FDA drags its heels unnecessarily with approvals to important cancer medications, giving patients compassionate use so early (Phase I) is problematic and provides patients with no guarantees to product safety. Interestingly, ASCO and the National Coalition for Cancer Survivorship (NCCS) both lined up behind the FDA on this one. A decision that I think of those organizations will probably regret in the coming years.
In the past, the FDA has completely botched the compassionate use priority. It has failed to enable access to lifesaving medications and surely thousands of patients could have lived (including Abigail, whom the Alliance was founded for after the FDA refused to allow access to Eribitux…which was eventually approved to treat Abigail’s tumor). Yet, enabling access too soon would likely cost even more lives. It’s a really tough decision, but it’s probably the right one.
While I do think that the FDA drags its heels unnecessarily with approvals to important cancer medications, giving patients compassionate use so early (Phase I) is problematic and provides patients with no guarantees to product safety. Interestingly, ASCO and the National Coalition for Cancer Survivorship (NCCS) both lined up behind the FDA on this one. A decision that I think of those organizations will probably regret in the coming years.
In the past, the FDA has completely botched the compassionate use priority. It has failed to enable access to lifesaving medications and surely thousands of patients could have lived (including Abigail, whom the Alliance was founded for after the FDA refused to allow access to Eribitux…which was eventually approved to treat Abigail’s tumor). Yet, enabling access too soon would likely cost even more lives. It’s a really tough decision, but it’s probably the right one.
A Challenging Day at Wyeth
It’s been a rather challenging morning over at Wyeth.
First, Wyeth and partner Solvay indicated the U.S. FDA has rejected the companies’ antipsychotic bifeprunox due to lacking efficacy data. The FDA will require an additional study prior to considering approval. (Wyeth press release here)
Bloomberg is noting that this is the fourth Wyeth drug that has been delayed this year.
Then, Wyeth and partner ViroPharma stopped a dosing trial for their Hepatitis C drug candidate HCV-796 due to safety concerns.
First, Wyeth and partner Solvay indicated the U.S. FDA has rejected the companies’ antipsychotic bifeprunox due to lacking efficacy data. The FDA will require an additional study prior to considering approval. (Wyeth press release here)
Bloomberg is noting that this is the fourth Wyeth drug that has been delayed this year.
Then, Wyeth and partner ViroPharma stopped a dosing trial for their Hepatitis C drug candidate HCV-796 due to safety concerns.
Wednesday, August 8, 2007
Red Cross Sued by J&J?
Johnson & Johnson suing the American Red Cross? Surely this is some sick joke by Pharmalot’s Ed Silverman. But no, it isn’t (here’s the Reuters story). In another “truth is far more interesting than fiction,” J&J has decided to go after the Red Cross for its symbol.
Here are the facts:
Here are the facts:
- American Red Cross founded in May 1881.
- J&J began using a red cross and “J&J” script letters in 1887.
- American Red Cross chartered by Congress in 1990.
And that’s all folks. That’s the basis of J&J’s lawsuit.
Talk about a public relations disaster! Recently, J&J has been given some positive ink on this blog and others for its PR savvy. But with a move like this, you have to wonder if they’ve hired Ruder Finn or something, because this is the PR equivalent of shooting yourself in both feet.
No word from J&J on how this fits with their credo. I imagine one the comedians in the Blogosphere will re-write the J&J Credo to be more in line with the ethics they are showing this week. I’m guessing the new J&J Credo will start something like, “We believe our first responsibility is to our shareholders...” Read the original J&J Credo, before it gets revised.
Normally, I’d post the logo of a company up here to give a little visual context to the topic. But if J&J’s lawyers are willing to bend the Red Cross over and have their way with them, I’m not taking chances. Instead, I opted for a photo of a J&J product. I figured they could use a little free advertising right now.
In a week of PR bungles, this one takes the cake!
Talk about a public relations disaster! Recently, J&J has been given some positive ink on this blog and others for its PR savvy. But with a move like this, you have to wonder if they’ve hired Ruder Finn or something, because this is the PR equivalent of shooting yourself in both feet.
No word from J&J on how this fits with their credo. I imagine one the comedians in the Blogosphere will re-write the J&J Credo to be more in line with the ethics they are showing this week. I’m guessing the new J&J Credo will start something like, “We believe our first responsibility is to our shareholders...” Read the original J&J Credo, before it gets revised.
Normally, I’d post the logo of a company up here to give a little visual context to the topic. But if J&J’s lawyers are willing to bend the Red Cross over and have their way with them, I’m not taking chances. Instead, I opted for a photo of a J&J product. I figured they could use a little free advertising right now.
In a week of PR bungles, this one takes the cake!
Updated: August 9, 2007:
J&J finally put out a statement about this mess (found on their website here). A couple of things.
First, whoever does PR at J&J must have been asleep on this one. It would have made a lot more sense to have their statement ready the day they filed the lawsuit, not the day after.
Second, the J&J press release claims it used the red cross symbol since 1887, "predating the formation of the American Red Cross." This is J&J spin on the facts. The American Red Cross was formed in May 1881, six years before J&J started using the symbol. The non-spin translation of the J&J statement is, "predating the Congressional charter." The American Red Cross still beat you to it. Maybe the American Red Cross can file a counter-suit alleging infringement by J&J and collecting damages for over a hundred years of infringement. Wouldn't that be nice? The Red Cross could be funded for life!
In all seriousness, it was a nice attempt at spin from J&J. Unfortunately, they put out their statement way too late and everybody had been doing their homework.
Still no revisions yet to the J&J Credo to reflect their new corporate values... I guess I'll need to wait a bit longer on that one.
Tuesday, August 7, 2007
Dendreon Focused on Moving Forward
After the recent torpedoing of its lead drug candidate, I decided to listen in on the Dendreon quarterly earnings call. As readers know, I usually don’t cover company earnings, but this is notable exception.
While acknowledging the challenging situation, management focused on moving forward. The company anticipates interim results of the IMPACT trial in mid-2008, which could be sufficient to amend the BLA and begin moving forward with the FDA (let’s not hold our breadth). Management said, “We have clarity on regulatory pathway in the United States.” Final results of the IMPACT will be available in 2010, but “enrollment continues to be strong.”
Management is focused on the ramping up of production at their New Jersey and Seattle facilities, which can holds down costs and ensures product access once approved by the FDA. The manufacturing issues identified are “well in hand,” but management did not see manufacturing as an issue in the approvable letter situation.
For the quarter ending June 30, 2007, revenue was $523,000, compared to $78,000 same period in 2006. The company was also able to slow the bleeding of expenses. For 2Q2007, expenses were $23.4 million, down from $26.3 million in 2006. Quarterly loss was $0.27, down from $0.35 from 2006.
The company took steps to distance it from patient advocates, however noted its disappointment in the FDA. Management wanted to, “thank patients, patient advocates and physicians for their support of Provenge,” although noted it does not endorse specific patient advocate tactics.
While acknowledging the challenging situation, management focused on moving forward. The company anticipates interim results of the IMPACT trial in mid-2008, which could be sufficient to amend the BLA and begin moving forward with the FDA (let’s not hold our breadth). Management said, “We have clarity on regulatory pathway in the United States.” Final results of the IMPACT will be available in 2010, but “enrollment continues to be strong.”
Management is focused on the ramping up of production at their New Jersey and Seattle facilities, which can holds down costs and ensures product access once approved by the FDA. The manufacturing issues identified are “well in hand,” but management did not see manufacturing as an issue in the approvable letter situation.
For the quarter ending June 30, 2007, revenue was $523,000, compared to $78,000 same period in 2006. The company was also able to slow the bleeding of expenses. For 2Q2007, expenses were $23.4 million, down from $26.3 million in 2006. Quarterly loss was $0.27, down from $0.35 from 2006.
The company took steps to distance it from patient advocates, however noted its disappointment in the FDA. Management wanted to, “thank patients, patient advocates and physicians for their support of Provenge,” although noted it does not endorse specific patient advocate tactics.
Management remains committed to moving forward. I applaud them for taking the high road in what has been a fairly ugly and repulsive situation.
Study Links Genentech’s Avastin to Blood Clots
A new study in today’s Journal of the National Cancer Institute found that patients treated with Avastin (bevacizumab) and chemotherapy had an increased risk of developing blood clots compared to patients receiving chemotherapy alone. The data are not entirely original since a sub-set of these data were presented at ASCO in 2005.
This is really a mixed bag, since patients treated with both Avastin and chemotherapy had increased survival with some solid-tumor cancers. Other evidence suggests that patients with these tumor types may be predisposed to artery clogging.
So patients get to choose: take Avastin, live longer and maybe develop a clot. Or skip Avastin and perhaps live a shorter life. Not a tough call here.
This is really a mixed bag, since patients treated with both Avastin and chemotherapy had increased survival with some solid-tumor cancers. Other evidence suggests that patients with these tumor types may be predisposed to artery clogging.
So patients get to choose: take Avastin, live longer and maybe develop a clot. Or skip Avastin and perhaps live a shorter life. Not a tough call here.
Discount Generic Prescriptions
Much has been made over the last year of the move by several pharmacies to offer low-cost/free generic prescriptions. Wal-Mart started the trend by offering $4 generic prescriptions in the Tampa, Florida area…slowing rolling it out to other areas. Target immediately followed suit.
The initial media sensation calmly gave way to the realization that the headline “$4 Prescription” was really only for a handful of drugs used to treat a limited number of conditions. Many Wal-Mart pharmacists complained that they were spending more time explaining the fine print of the deal to seniors than they were doing their jobs. That’s what we call a loss-leader – getting the folks in the door, get them captive and fill ALL their prescriptions…even if the other products are more expensive than they would be down the street at Walgreens. This begs the question, which store really offers “Every Day Low Prices?”
Now, regional grocery store Publix in Florida has upped the ante. They are now offering completely free prescriptions! Here are the sensational headlines:
- Publix Super Market to offer free antibiotics (CNN Money/Reuters)
- Publix offers free medicine (Orlando Sentinel)
- Publix pharmacies launch free prescription drug program (Tampa Business Journal)
What’s the catch? Well, it’s only seven generic drugs. And you can only get a 14-day supply. And most of the drugs on the Publix list have antibiotic resistance issues. So you might be able to get your generic antibiotic if its on the list, but it may not work since so many bacteria strains are resistant. Is it really a good deal after all?
Don’t get me wrong, I applaud Publix, Wal-Mart and Target for lowering the prices on their generic drugs. These generic drugs are where pharmacies make their money with huge mark-ups on consumers. Lowering the prices will help patients. But consumers, particularly cash paying consumers, need to understand that just because a couple of drugs may be cheap or free, they may not be getting a good deal all the way around.
Photo: Jacob Langston, Orlando Sentinel
Pfizer Wins Selzentry Approval
The U.S. FDA decided to follow the advice of its advisory committee and approved Pfizer’s Selzentry (maraviroc) for the treatment of HIV in patients that had failed other therapies. Pfizer indicated the drug should be available to patients in September.
The is news for three reasons – 1) This is the first-of-its-kind treatment for drug-resistant forms of HIV; 2) This is the first piece of good news Pfizer has had in a while given its R&D woes; and 3) The FDA actually followed the advice of its advisory committee (unlike the recent Provenge debacle).
I saw the future of Selzentry last night in a dream. A certain unnamed doctor at the FDA will use a Ouija board to complete another infamous meta-analysis of all studies on the drug and compare it to placebo. In his study, he will find that patients with HIV taking maraviroc die at rates higher than patients without HIV. What’s to blame – the disease or the drug? The doctor concludes it is the drug. Instead of publishing in a medical journal, he goes out on a publicity tour. The resulting media coverage pressures the FDA to pull the drug from the market based on his “scientific” study. Only to allow it back on the market later (a la Zelnorm). Around that time, I woke up from the dream. For the sake of patients who need this drug, I hope that Selzentry won’t become another soap opera.
Encysive Gets Decisive
Encysive announced late yesterday that it had filed a request for formal dispute resolution with the FDA. Encysive’s now former CEO Dr. Bruce D. Given indicated back on June 18 that this move would be coming (see Encysive Excises Executives and Encysive Strikes Back).
Now all that’s left is to find a buyer.
Also see the Reuters story.
Now all that’s left is to find a buyer.
Also see the Reuters story.
Monday, August 6, 2007
Physicians Milk Profits from Patients
An article in the South Florida Sun Sentinel by Bob LeMendola caught my eye. Some physicians are charging patients “annual maintence fees” of between $250-400 just for the privilege of having the option of being able to visit the practice. These are not luxury practices or cash-only practices…these are your standard practices.
The Sun Sentinel quotes Dr. May Colburn a geriatrician in West Palm Beach as saying, "We don't want to do this. I wish it were not so that we were in this position. But we are.” I guess there must be a shortage of seniors in South Florida that led Dr. Colburn to pump her patients for more cash. If all of her patients pay the fee which she claims is “voluntary,” she pockets an extra $100,000 a year. One has to wonder if this is truly being presented to patients as a “voluntary/optional” charge.
Last year, the average U.S. physician made $330,000, according to the Sun Sentinel. Slightly less for GPs and pediatricians, but more for most other specialties. BLS puts net salaries for FP/GPs at $149,850, almost four times the salary of the average U.S. employee which is only $39,190. Coincidentally, CNN reported back in April that a large number of physicians comprise the “ultra high net worth” club, those with more than $5 million in assets.
I guess physicians need the extra $250 per patient to maintain their “lifestyles.” It makes up for the lunches they need to buy now that drug companies are cutting back. Although, the good news is that many younger doctors no longer need to actually pay for their medical schooling with various state governments picking up the tabs.
There is the outstanding question of whether this is legal, with respect to Medicare patients. Charging Medicare patients non-specific fees to boost your bottom line is illegal. Some Medicare patient who takes on the practice, could make a pretty penny.
The Sun Sentinel quotes Dr. May Colburn a geriatrician in West Palm Beach as saying, "We don't want to do this. I wish it were not so that we were in this position. But we are.” I guess there must be a shortage of seniors in South Florida that led Dr. Colburn to pump her patients for more cash. If all of her patients pay the fee which she claims is “voluntary,” she pockets an extra $100,000 a year. One has to wonder if this is truly being presented to patients as a “voluntary/optional” charge.
Last year, the average U.S. physician made $330,000, according to the Sun Sentinel. Slightly less for GPs and pediatricians, but more for most other specialties. BLS puts net salaries for FP/GPs at $149,850, almost four times the salary of the average U.S. employee which is only $39,190. Coincidentally, CNN reported back in April that a large number of physicians comprise the “ultra high net worth” club, those with more than $5 million in assets.
I guess physicians need the extra $250 per patient to maintain their “lifestyles.” It makes up for the lunches they need to buy now that drug companies are cutting back. Although, the good news is that many younger doctors no longer need to actually pay for their medical schooling with various state governments picking up the tabs.
There is the outstanding question of whether this is legal, with respect to Medicare patients. Charging Medicare patients non-specific fees to boost your bottom line is illegal. Some Medicare patient who takes on the practice, could make a pretty penny.
The Week Ahead – August 6-12
August 7 – CMS Region V Congressional Briefing Minneapolis/St. Paul MN – The Chicago Regional Office of the Centers for Medicare & Medicaid Services will be hosting a series of U.S. Congressional and State Legislature briefings for district office staff throughout our Region. This years briefing will provide basic training and updates on the Medicare and Medicaid programs. The briefings will provide U.S. Congressional and State Legislature district office staff valuable information and assist them with handling their constituents’ questions.
Friday, August 3, 2007
House Green Lights Drug Imports
Late Thursday, the U.S. House passed a law that would green light importation of drugs from other counties – namely “Canada,” Australia and Europe. The move comes at a time where those same countries are struggling to keep tainted Chinese drugs out. So what’s to keep the tainted Chinese drugs from Coming to America – nothing.
The law was attached to $91 billion dollar pork barrel package of farm subsidies, nutrition programs and other gimmicks. The bill cleared on a 237-28 vote, but faces a veto from President Bush.
According to the AP (I’m going to quote so I get their logic right): “Supporters of the idea say it would save consumers great sums by allowing them to purchase U.S.-made medications from other countries where they often sell for much lower prices than in the U.S.” Right. And how to keep the counterfeit drugs out? Supporters have no idea.
The brightest thing said in Washington yesterday: “I understand the intention to lower drug prices to seniors, that is critically important. What we’re doing is throwing open the gates to every (drug) counterfeiter in the world”-Rep. Mike Rogers (R-MI). Bingo.
By the slightly more interesting quote was Rep. JoAnn Emerson (R-MO) who said, “I would prefer to stand up for my constituents in Missouri as opposed to the pharmaceutical companies keep competition and low prices out of this country.” No JoAnn. That’s not how it works. You are not keeping low prices out, you are importing everyone else’s subsidized prices (the reason why prices are higher in the U.S. in the first place).
I’ve talked about this issue before in The Realities of Importation and The UN Report on Drug Counterfeiting.
The law was attached to $91 billion dollar pork barrel package of farm subsidies, nutrition programs and other gimmicks. The bill cleared on a 237-28 vote, but faces a veto from President Bush.
According to the AP (I’m going to quote so I get their logic right): “Supporters of the idea say it would save consumers great sums by allowing them to purchase U.S.-made medications from other countries where they often sell for much lower prices than in the U.S.” Right. And how to keep the counterfeit drugs out? Supporters have no idea.
The brightest thing said in Washington yesterday: “I understand the intention to lower drug prices to seniors, that is critically important. What we’re doing is throwing open the gates to every (drug) counterfeiter in the world”-Rep. Mike Rogers (R-MI). Bingo.
By the slightly more interesting quote was Rep. JoAnn Emerson (R-MO) who said, “I would prefer to stand up for my constituents in Missouri as opposed to the pharmaceutical companies keep competition and low prices out of this country.” No JoAnn. That’s not how it works. You are not keeping low prices out, you are importing everyone else’s subsidized prices (the reason why prices are higher in the U.S. in the first place).
I’ve talked about this issue before in The Realities of Importation and The UN Report on Drug Counterfeiting.
DC Drug Pricing Law Tossed Out
An U.S. Court of Appeals upheld a lower court’s decision that the Washington D.C. Prescription Drug Excessive Pricing Act of 2005 was unconstitutional. The 2005 law was rule unconstitutional in December 2005 by the U.S. District Court for the District of Columbia. [BIO press release here.]
In a side note, this is ironically the second piece of unconstitutional legislation that was backed by the National Litigation Association of Prescription Drug Prices (NLARX). [Read their press release on the D.C. law.] The first constitutionally flawed legislation was their physician secrecy law (See New Hampshire Data Ban Struck Down). The group claims to be an organization of state legislators trying to rein in drug prices and abolish capitalism in America. Evidently, it is evolving into a group trying to overthrow the Constitution as a whole. Next up for NLARX: Abolishing the 15th Amendment to the Constitution.
In a side note, this is ironically the second piece of unconstitutional legislation that was backed by the National Litigation Association of Prescription Drug Prices (NLARX). [Read their press release on the D.C. law.] The first constitutionally flawed legislation was their physician secrecy law (See New Hampshire Data Ban Struck Down). The group claims to be an organization of state legislators trying to rein in drug prices and abolish capitalism in America. Evidently, it is evolving into a group trying to overthrow the Constitution as a whole. Next up for NLARX: Abolishing the 15th Amendment to the Constitution.
Thursday, August 2, 2007
Biota Ups the Ante on GSK
On Tuesday, the small biotech firm Biota in Australia raised its claim to between $479-599 million U.S. dollars. Biota asserts that GSK failed to promote Relenza in the U.S. and the company is thus entitled to damages. I’ve covered background on this issue in More Flu Drug Drama for Biota.
This hasn’t been a good week for GSK’s legal department. Earlier this week, two class action suits were filed in Canada against the Anglo drugmaker for risks associated with Avandia. No doubt there will be many more where these came from.
This hasn’t been a good week for GSK’s legal department. Earlier this week, two class action suits were filed in Canada against the Anglo drugmaker for risks associated with Avandia. No doubt there will be many more where these came from.
Clearing the Air on Provenge
After the last few weeks and my most recent posting (Provenge – The Companies and the PR Firm) on the topic of Provenge, Dendreon, Novacea and the FDA "situation," I wanted to take a minute to address some of the e-mails I have received on the topic.
First, I do not work for Dendreon and never have. I don’t even know anyone who works for Dendreon. Dendreon has not paid me to write about this, nor have any cancer activists. I am writing about it because I find the outcome perplexing and the lack of transparency about the process concerning.
Second, I have approached Dr. Scher on this topic. Not surprisingly, there has been no comment back. He must be taking PR advice from the same folks at Ruder Finn that Novartis is using. I have given Scher the opportunity to provide any statement he wishes, which I would post here in its entirety.
In conclusion, I do believe that some seriously unethical behavior has transpired. I will leave it to the lawyers to decide whether it was also illegal.
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