Pfizer has finally caved to pressure and will pull the Dr. Jarvik Lipitor ads.
The Lipitor ads have been resoundingly criticized by opponents of DTC advertising. The main reason has been that Dr. Jarvik, although a graduate of medical school, has focused on research and is not a licensed physician. Then it was revealed that the ads were deceptive because Dr. Jarvik doesn’t row, despite a body double depicted in the ads is rowing on a lake. Then Jarvik was accused of being a non-runner, despite being depicted running. And perhaps the most controversial attack by the anti-DTC crowd is an e-mail campaign hinting that Jarvik had no role in developing the Jarvik-7 artificial heart which bears his name.
Pfizer’s willingness to cave to anti-DTC foes could signal even more radical transformations ahead. I have suspected that at least one pharma company would back-off DTC completely in the next year to 18 months.
Tuesday, February 26, 2008
Monday, February 25, 2008
FDA Approves Avastin for Breast Cancer; Controversy Erupts
Late Friday, the FDA approved Genentech’s Avastin for breast cancer. The recommendation goes against the FDA’s own advisory panel – something they’ve been doing a lot of these days.
Yet, as Matt Perrone notes in his Associated Press article, this “could represent a shift in standards for assessing the effectiveness of cancer medicines.” The FDA based its assessment on tumor size and not on overall survival.
Some patient groups and agency watchdogs are complaining that it represents a lowering of standards and is a tacit approval of off-label usage, based on economics, not science.
Yet, I have to wonder if the Avastin indication was for prostate cancer, and not breast cancer, would we have seen a similar approval?
Yet, as Matt Perrone notes in his Associated Press article, this “could represent a shift in standards for assessing the effectiveness of cancer medicines.” The FDA based its assessment on tumor size and not on overall survival.
Some patient groups and agency watchdogs are complaining that it represents a lowering of standards and is a tacit approval of off-label usage, based on economics, not science.
Yet, I have to wonder if the Avastin indication was for prostate cancer, and not breast cancer, would we have seen a similar approval?
Thursday, February 21, 2008
Antigenics’ Oncophage Gets Mixed Results
Antigenics therapeutic cancer vaccine Oncophage got a mixed bag in the metastatic melanoma trial. It showed no increased overall survival (the gold standard), but a sub-population receiving a minimum of 10 injections saw an increased median survival of 3.7 months.
I know that I have publicly questioned whether an increased survival of 4 months is worth it to approve a product. More importantly – is it worth it to the government or a health plan to pay for a drug that only increases survival by almost 4 months?
In the debate about healthcare, what is your best interest as a patient (i.e., the best quality care) is not necessarily in the financial interests of the person paying the bills (i.e., keeping costs down). I believe patients have the right to the best products available and any product that has the potential to increase their cancer survival. But approval of the products does not mean universal access to those products. The FDA shouldn’t be approving drugs based on the finances, only on the safety and relative efficacy.
Cancer vaccines haven’t exactly had a strong run lately. With the torpedoing of Dendreon’s Provenge, the lead cancer vaccine in trials, there is less certainty these novel, targeted approaches to treating cancer will ever make it to market.
I know that I have publicly questioned whether an increased survival of 4 months is worth it to approve a product. More importantly – is it worth it to the government or a health plan to pay for a drug that only increases survival by almost 4 months?
In the debate about healthcare, what is your best interest as a patient (i.e., the best quality care) is not necessarily in the financial interests of the person paying the bills (i.e., keeping costs down). I believe patients have the right to the best products available and any product that has the potential to increase their cancer survival. But approval of the products does not mean universal access to those products. The FDA shouldn’t be approving drugs based on the finances, only on the safety and relative efficacy.
Cancer vaccines haven’t exactly had a strong run lately. With the torpedoing of Dendreon’s Provenge, the lead cancer vaccine in trials, there is less certainty these novel, targeted approaches to treating cancer will ever make it to market.
Wednesday, February 20, 2008
Encysive Finds White Knight: Pfizer
Encysive, the beleaguered House-based biotech firm, has found their White Knight – Pfizer for kingly price of $195 million. While that’s not a lot for the purchase of an entire company, Encysive isn’t exactly commanding a premium in the marketplace these days.The company has been unsuccessfully petitioning the FDA to review the company’s third approvable letter for Thelin. That’s right: third approvable letter. When it became obvious it was hopeless, Encysive excised its executives, including the former CEO Bruce Given.
This is the equivalent of a lottery scratch ticket for Pfizer – small investment, decent chance of return. The $195 million investment is not a substantial one for Pfizer and the payoff will likely happen, as Thelin is already approved in Canada and Europe. (Note: Given the recent divergence of the FDA from global harmonization standards, approval in Europe is no longer a signal the product will get approved in the U.S.). Pfizer will have to do the Phase III trial over and contend with being second to market since the Gilead Sciences/Myogen Letairis already received approval.
A shareholder suit against Encysive was dismissed back in October.
Judge Tosses Thimerosal Case
Judge Stuart R. Berger in Baltimore tossed a case against Wyeth alleging that thimerosal caused Jamarr Blackwell’s case of autism (Blackwell, et al. v. Sigma Aldrich, Inc., et al). There are hundreds of these gold digger cases pending and this decision is likely to lessen the potential that some of these will ever see trial.
From the Judge’s decision: "It is generally accepted in the relevant scientific community that thimerosal in vaccines does not cause or contribute to neurodevelopmental disorders such as autism.” Further, "It is generally accepted in the relevant scientific community that autism is genetic in origin except in rare instances of prenatal exposures to certain substances at defined periods during pregnancy."
From the Judge’s decision: "It is generally accepted in the relevant scientific community that thimerosal in vaccines does not cause or contribute to neurodevelopmental disorders such as autism.” Further, "It is generally accepted in the relevant scientific community that autism is genetic in origin except in rare instances of prenatal exposures to certain substances at defined periods during pregnancy."
Tuesday, February 19, 2008
Actavis Recalls Generic Fentanyl
Actavis’ generic Duragesic (transdermal fentanyl) has been recalled in the U.S. A manufacturing defect could result in patients receiving a much more concentrated dosing through contact directly with the gel.
Transdermal fentanyl has been plagued by problems in recent years. Last week, Johnson & Johnson recalled some of its branded Duragesic patches. And a few years ago, there were a number of fentanyl deaths from the patches in which patients were cutting out the gels and taking them orally or rectally.
Transdermal fentanyl has been plagued by problems in recent years. Last week, Johnson & Johnson recalled some of its branded Duragesic patches. And a few years ago, there were a number of fentanyl deaths from the patches in which patients were cutting out the gels and taking them orally or rectally.
Sunday, February 17, 2008
Provenge Won’t Get Hearing
The House Energy and Commerce Committee won’t hold hearings on the FDA’s unorthodox handling of Dendreon’s Provenge. After being urged not to pursue the hearing, Rep. John Dingell (D-MI) backed down citing, among other things, the argument that the agency had not yet made a decision, therefore it would be premature to investigate.
The House Energy and Commerce Committee seems to have bought into the mistaken believe that the FDA hasn’t actually made a decision. I would argue that they have. They have thrown Provenge into Guantanamo Bay – to held without the benefit of due process.
Such is how our U.S. Government operates these days.
The House Energy and Commerce Committee seems to have bought into the mistaken believe that the FDA hasn’t actually made a decision. I would argue that they have. They have thrown Provenge into Guantanamo Bay – to held without the benefit of due process.
Such is how our U.S. Government operates these days.
Thursday, February 7, 2008
Merck Gets Spanked
It’s been a rough start to 2008 for the Whitehouse Station drug Giant.
For much of January, the Merck/Schering-Plough combo pill Vytorin has been in the news for being no more effecting in reducing heart disease than simvastatin (Zocor) alone. Consumer groups are crying fowl and New York has subpoenaed company records, and presumably other states will be following their lead.
Today, Merck announced it had settled a $400 million dollar settlement with 49 states and Washington, D.C. on charges the company manipulated average pricing to defraud and overcharge the Medicaid program. Only Arizona did not participate in the settlement. Part of the agreement also resolves charges that Merck paid kickbacks and other enticements to doctors for prescribing Zocor and Vioxx.
Merck thought they had seen the worst of it with Vioxx, but it looks like the tough times may continue for a little while longer.
For much of January, the Merck/Schering-Plough combo pill Vytorin has been in the news for being no more effecting in reducing heart disease than simvastatin (Zocor) alone. Consumer groups are crying fowl and New York has subpoenaed company records, and presumably other states will be following their lead.
Today, Merck announced it had settled a $400 million dollar settlement with 49 states and Washington, D.C. on charges the company manipulated average pricing to defraud and overcharge the Medicaid program. Only Arizona did not participate in the settlement. Part of the agreement also resolves charges that Merck paid kickbacks and other enticements to doctors for prescribing Zocor and Vioxx.
Merck thought they had seen the worst of it with Vioxx, but it looks like the tough times may continue for a little while longer.
Heath Ledger Dies of Accidental Rx OD
No surprises, here, but Heath Ledger’s death was ruled an accidental overdue. The medical examiner noted that Ledger’s system contained: OxyContin, Valium, Xanax and some sleeping pills.
According to media reports, it seems the Ledger had seen different doctors in both the U.S. and Europe to obtain all of the various prescriptions.
My question is – what doctor in the world would ever prescribe OxyContin or hydrocodone for insomnia? Supposedly, the only ill afflicting Ledger was that of extreme insomnia due to the rigors of his filming schedule.
According to media reports, it seems the Ledger had seen different doctors in both the U.S. and Europe to obtain all of the various prescriptions.
My question is – what doctor in the world would ever prescribe OxyContin or hydrocodone for insomnia? Supposedly, the only ill afflicting Ledger was that of extreme insomnia due to the rigors of his filming schedule.
Pharma Freebies
The tongue-in-cheek sign on the door to Dr. Bennett’s practice used to read, “Patients – Please bring your own pen.”
When his health system decided to get off the pharma gravy train about a year and half ago, doctors were no longer allowed to accept pharma freebies, including pens. Dr. Bennett thought it was ridiculous that health system brass could cozy up with executives from insurance companies at fancy dinners or accept free trips to Mexico, but he couldn’t accept a single pen. So he told patients to bring their own. If they complained, he gave them the phone number of the health system brass who made the decision.
In the exam room, Dr. Bennett would even borrow patient’s pens so he could make notes in their charts. When patients questioned about the lack of pens, with a big smile Dr. Bennett would explain that the system didn’t want his judgment clouded by the name on a pen, so it abolished them – completely. You see, the brass at the health system had said in their edict to physicians that all pens with logos must go, and they failed to specify it was only pens with pharmaceutical company or drug logos. Dr. Bennett suspected the health system brass hurriedly wrote the note on a private insurance company jet on the way back from St. Kitts.
Most patients thought it was funny, but one didn’t and complained. The health system didn’t think Dr. Bennett was being very funny. They threatened to revoke his medical staff privileges if he didn’t stop, so Dr. Bennett caved. The sign has come down and he has started paying for pens – which have logos on them.
[I would like to thank Dr. Bennett for recounting this story over dinner. It should also be said that Dr. Bennett paid for his own dinner.]
When his health system decided to get off the pharma gravy train about a year and half ago, doctors were no longer allowed to accept pharma freebies, including pens. Dr. Bennett thought it was ridiculous that health system brass could cozy up with executives from insurance companies at fancy dinners or accept free trips to Mexico, but he couldn’t accept a single pen. So he told patients to bring their own. If they complained, he gave them the phone number of the health system brass who made the decision.
In the exam room, Dr. Bennett would even borrow patient’s pens so he could make notes in their charts. When patients questioned about the lack of pens, with a big smile Dr. Bennett would explain that the system didn’t want his judgment clouded by the name on a pen, so it abolished them – completely. You see, the brass at the health system had said in their edict to physicians that all pens with logos must go, and they failed to specify it was only pens with pharmaceutical company or drug logos. Dr. Bennett suspected the health system brass hurriedly wrote the note on a private insurance company jet on the way back from St. Kitts.
Most patients thought it was funny, but one didn’t and complained. The health system didn’t think Dr. Bennett was being very funny. They threatened to revoke his medical staff privileges if he didn’t stop, so Dr. Bennett caved. The sign has come down and he has started paying for pens – which have logos on them.
[I would like to thank Dr. Bennett for recounting this story over dinner. It should also be said that Dr. Bennett paid for his own dinner.]
Monday, February 4, 2008
Takeda and Amgen Ink Deal
Takeda and Amgen have inked a deal worth $1.2 billion for Takeda to commercialize about 13 different drugs from Amgen’s pipeline in Japan. The deal looks to be a white flag of surrender for the once-prideful Takeda, who explored and rejected other partnerships in the 1990’s.
Of course, all of this assumes the Japanese regulatory authority approves the compounds. For the last half-decade, Japan has lagged nearly every other developed country in access to oncologic therapies. While there are signs this may be easing, the chances that all (or even most) of the 13 candidates in the partnership actually make it to the Japanese market is low.
Source: Amgen Press Release
Of course, all of this assumes the Japanese regulatory authority approves the compounds. For the last half-decade, Japan has lagged nearly every other developed country in access to oncologic therapies. While there are signs this may be easing, the chances that all (or even most) of the 13 candidates in the partnership actually make it to the Japanese market is low.
Source: Amgen Press Release
Catching Up on My Blog Reading
I spent the weekend getting caught up on my blog reading, including much of the time reading Drug Wonks. Drug Wonks is the much maligned pro-pharma industry blog of the Center for Medicine in the Public Interest (CMPI). The blog is written by Peter Pitts and Robert Goldberg.
I love the Drug Wonks blog because they tackle the tough issues facing the industry from an industry perspective. In short, they do the job of PhRMA (begs the question what does PhRMA actually do?).
Take this gem of a posting: The Media’s Suicide Watch. They probe beyond the flip headline to really explore the science behind the sensationalist, anti-pharma headlines funded by trial lawyers.
While I don’t always agree with Drug Wonks or some of the positions they take on the industry, I value the voice and perspective that they bring to the conversation.
I love the Drug Wonks blog because they tackle the tough issues facing the industry from an industry perspective. In short, they do the job of PhRMA (begs the question what does PhRMA actually do?).
Take this gem of a posting: The Media’s Suicide Watch. They probe beyond the flip headline to really explore the science behind the sensationalist, anti-pharma headlines funded by trial lawyers.
While I don’t always agree with Drug Wonks or some of the positions they take on the industry, I value the voice and perspective that they bring to the conversation.
Subscribe to:
Posts (Atom)