Much has been made recently of the growing problem of prescription drug shortages. This has become yet another thing for industry adversaries to criticize. But a new report (“Drug Shortages: A Closer Look at Products, Suppliers and Volume Volatility”) from the IMS Institute for Healthcare Informatics sheds light on the topic.
The issue of prescription drug shortages is primarily, and almost exclusively, limited to injectable generic medications. Of products that have had shortage issues, over 80 percent are generic injectables. Oncology products make up 16 percent of drugs with shortages (such as Johnson & Johnson's Doxil which has a waitlist of over 2,700 people). Most of the products that have shortages are manufactured by only 1 or 2 generic manufacturers.
Early warning systems, like the one IMS is advocating, will help predict these shortages in the future. Unfortunately, this won’t actually stop the shortages. It’s unfortunate that government policies have created this situation to begin with.
Sunday, November 20, 2011
TEDMED 2011
A few weeks back, I had the privilege to attend TEDMED 2011. TEDMED is an event like no other – the atmosphere was so rarified. In my 35+ years in the healthcare industry, this was the single best conference I’ve ever been to.
For me, I personally enjoyed Juan Enriquez’s (of Excel Venture Management) scathing indictment of the FDA. He asked the attendees to change the counting. In addition to counting how many people the FDA saves, we also need to count the number of people the FDA kills through their delays. And the number of “FDA kills” is probably as great or greater than the number of “FDA saves.”
I was also moved by the mushroom guy – Paul Stamets (of Fungi Perfecti). He is researching how certain mushrooms from old growth forests in the Pacific Northwest can treat cancer. I had no idea this research was going on.
The presentation by Lee Stein (Prize Capital LLC and Virtual Group LLC) about his son’s sky diving accident and subsequent MRI scans revealing a possibly fatal condition was moving. The way NYU was able to work with the MRI manufacturer to push the limits of research was noteworthy.
For those who haven’t been to TEDMED, it’s tough to explain how special it is – and it is special!! I absolutely can’t wait for TEDMED 2012 in Washington, DC.
For me, I personally enjoyed Juan Enriquez’s (of Excel Venture Management) scathing indictment of the FDA. He asked the attendees to change the counting. In addition to counting how many people the FDA saves, we also need to count the number of people the FDA kills through their delays. And the number of “FDA kills” is probably as great or greater than the number of “FDA saves.”
I was also moved by the mushroom guy – Paul Stamets (of Fungi Perfecti). He is researching how certain mushrooms from old growth forests in the Pacific Northwest can treat cancer. I had no idea this research was going on.
The presentation by Lee Stein (Prize Capital LLC and Virtual Group LLC) about his son’s sky diving accident and subsequent MRI scans revealing a possibly fatal condition was moving. The way NYU was able to work with the MRI manufacturer to push the limits of research was noteworthy.
For those who haven’t been to TEDMED, it’s tough to explain how special it is – and it is special!! I absolutely can’t wait for TEDMED 2012 in Washington, DC.
Sunday, November 6, 2011
Surgeon General Regina Benjamin’s Diet
At TEDMED two weeks ago, I had the opportunity to have lunch with Surgeon General Regina Benjamin. It was eye opening, to say the least. Surgeon General Benjamin was pleasant, but didn’t exactly impress. My personal feeling is that she wasn’t the most qualified person for the Surgeon General role. That said, I would like her to succeed in her mission, but am skeptical she's up to the task.
Surgeon General Benjamin encouraged the TEDMED attendees to lead a healthier life and get out there and move around. But like most things with the White House – it was a do-as-mandate-not-as-I-do. I didn’t see Regina Benjamin at any of the TEDMED exercise opportunities such as the walks or yoga or in the gym at the Hotel del Coronado.
But my lunch with Regina Benjamin was eye opening. First Lady Michelle Obama recently launched the new Food Plate (i.e., the replacement to the food pyramid). But Michelle Obama should talk to Regina Benjamin because she didn’t get the memo – Regina Benjamin’s actual food plate looked more like Michael Moore’s than the new recommendations from Michelle Obama.
Of course, this is the White House where the President smokes and exposes his two daughters to second-hand smoke.
Public Health in the United States seems to be moving in the wrong direction. We need real public health leadership. Instead, we’re getting health tips from Aunt Jemima and the Marlboro Man.
Surgeon General Benjamin encouraged the TEDMED attendees to lead a healthier life and get out there and move around. But like most things with the White House – it was a do-as-mandate-not-as-I-do. I didn’t see Regina Benjamin at any of the TEDMED exercise opportunities such as the walks or yoga or in the gym at the Hotel del Coronado.
But my lunch with Regina Benjamin was eye opening. First Lady Michelle Obama recently launched the new Food Plate (i.e., the replacement to the food pyramid). But Michelle Obama should talk to Regina Benjamin because she didn’t get the memo – Regina Benjamin’s actual food plate looked more like Michael Moore’s than the new recommendations from Michelle Obama.
Of course, this is the White House where the President smokes and exposes his two daughters to second-hand smoke.
Public Health in the United States seems to be moving in the wrong direction. We need real public health leadership. Instead, we’re getting health tips from Aunt Jemima and the Marlboro Man.
Tuesday, October 25, 2011
TEDMED 2011
I know Pharm Aid has been quiet lately. Actually, Pharm Aid has been quiet for a lot longer than just lately. I guess I've been enjoying my retirement. I also had some medical problems and spent the latter part of the summer having surgery and recovering. But this old dog isn't going to kick the bucket just yet. And this blog isn't dead quite yet either.
I'm attending TEDMED 2011 this week in sunny San Diego! The venue (Hotel del Coronado) is beautiful and the agenda looks to be extremely robust. I'll be live blogging and Tweeting the whole conference. Be sure to follow me on Twitter: http://twitter.com/pharmaid for the latest news.
I'm attending TEDMED 2011 this week in sunny San Diego! The venue (Hotel del Coronado) is beautiful and the agenda looks to be extremely robust. I'll be live blogging and Tweeting the whole conference. Be sure to follow me on Twitter: http://twitter.com/pharmaid for the latest news.
Sunday, May 1, 2011
Warren Buffett Spanks J&J’s Management
Warren Buffett’s Berkshire Hathaway is the fourth largest shareholder of Johnson & Johnson. You image that J&J would care about what its fourth largest thinks, but that doesn’t seem to be the case.
When J&J announced its $21.5 billion deal for the Switzerland-based med-device firm Synthes, many were surprised that J&J offered mostly equity in the deal. J&J has a huge pile of case, but they seem to be holding it in reserve for more massive payouts to CEO William Weldon. When financially well-managed companies do deals, they try to do them in the most favorable way possible. Why J&J would dilute its shares when it has the cash is baffling. And that’s Warren Buffett’s point. What’s personally good for J&J’s management isn’t good for J&J’s shareholders.
Meanwhile, on Friday, Fitch Ratings is signaling it will downgrade J&J’s credit rating due to the excessive and unnecessary debt load the company is taking on in the Synthes acquisition. Conveniently for J&J’s management, Fitch delayed its announcement until after the company’s Annual Shareholder Meeting last Thursday.
From my perspective, J&J is buying revenue to mask the damage that the company’s management has inflicted over the past few years. However, on the upside, Synthes is a strong cultural fit for J&J – Synthes has also been plagued by recalls and quality problems over the last few years.
When J&J announced its $21.5 billion deal for the Switzerland-based med-device firm Synthes, many were surprised that J&J offered mostly equity in the deal. J&J has a huge pile of case, but they seem to be holding it in reserve for more massive payouts to CEO William Weldon. When financially well-managed companies do deals, they try to do them in the most favorable way possible. Why J&J would dilute its shares when it has the cash is baffling. And that’s Warren Buffett’s point. What’s personally good for J&J’s management isn’t good for J&J’s shareholders.
Meanwhile, on Friday, Fitch Ratings is signaling it will downgrade J&J’s credit rating due to the excessive and unnecessary debt load the company is taking on in the Synthes acquisition. Conveniently for J&J’s management, Fitch delayed its announcement until after the company’s Annual Shareholder Meeting last Thursday.
From my perspective, J&J is buying revenue to mask the damage that the company’s management has inflicted over the past few years. However, on the upside, Synthes is a strong cultural fit for J&J – Synthes has also been plagued by recalls and quality problems over the last few years.
Monday, April 25, 2011
The Link Between Pharma Data and Prescription Drug Abuse
Tomorrow, the United States Supreme Court will hear an important case on the freedom of information and it should be of great interest to everyone in the pharmaceutical industry. The case, Sorrell v. IMS Health, looks at free speech. At issue in the case is whether States have the right to enact special secrecy laws for physicians by banning the lawful use of information for supposedly altruistic (if often, unsubstantiated) reasons.
These laws were passed in New Hampshire, Vermont and Maine, at the urging of a group called the National Legislative Association on Prescription Drug Prices (NLARx). Just how these physician secrecy laws are supposed to drive down prescription prices has not be adequately explained by the NLARx. I guess we were just supposed to believe them on it. Since these laws were passed in 2006, the States of Maine, Vermont and New Hampshire have not made a single effort at reducing prescription drug prices via any provision of these laws.
Whatever the Supreme Court decides in the case of Sorrell v. IMS Health, NLARx Executive Director Sharon Treat and her allies have already won. Last week came the news that Sharon Treat’s home state of Maine now has the highest rate of prescription drug abuse in the country. Why? Physicians in Maine are more likely to prescribe narcotics to patients who don’t need it than any State in the USA. Thanks to Sharon Treat’s efforts, doctors have nothing to fear from people looking over their shoulder. In fact, Maine’s much lauded Prescription Management Program focuses on individual patients. It doesn’t look for patterns in prescribers. A program run by the pharmaceutical industry was shut down, again, thanks to Sharon Treat.
In fact, if you look at States with the highest drug diversion and the highest problems of prescription drug abuse, they are all States that have regulated pharmaceutical prescription data (Maine, Vermont and New Hampshire). Coincidence? Unlikely.
So, whatever the Supreme Court decides, Sharon Treat and the NLARx have already won. In 2009, after Sharon Treat was able to get her law passed in Maine, prescription drug deaths jumped to over 160 per year. In Maine, every day, a baby is born addicted to prescription drugs. Those rates have only continued to climb. Just last week, the Federal Government noted that Maine has the worst prescription drug abuse problem in the country. So, the Supreme Court can take its time – Sharon Treat and the NLARx have already won…and the bodies are piling up in Maine to prove that I’m right.
These laws were passed in New Hampshire, Vermont and Maine, at the urging of a group called the National Legislative Association on Prescription Drug Prices (NLARx). Just how these physician secrecy laws are supposed to drive down prescription prices has not be adequately explained by the NLARx. I guess we were just supposed to believe them on it. Since these laws were passed in 2006, the States of Maine, Vermont and New Hampshire have not made a single effort at reducing prescription drug prices via any provision of these laws.
Whatever the Supreme Court decides in the case of Sorrell v. IMS Health, NLARx Executive Director Sharon Treat and her allies have already won. Last week came the news that Sharon Treat’s home state of Maine now has the highest rate of prescription drug abuse in the country. Why? Physicians in Maine are more likely to prescribe narcotics to patients who don’t need it than any State in the USA. Thanks to Sharon Treat’s efforts, doctors have nothing to fear from people looking over their shoulder. In fact, Maine’s much lauded Prescription Management Program focuses on individual patients. It doesn’t look for patterns in prescribers. A program run by the pharmaceutical industry was shut down, again, thanks to Sharon Treat.
In fact, if you look at States with the highest drug diversion and the highest problems of prescription drug abuse, they are all States that have regulated pharmaceutical prescription data (Maine, Vermont and New Hampshire). Coincidence? Unlikely.
So, whatever the Supreme Court decides, Sharon Treat and the NLARx have already won. In 2009, after Sharon Treat was able to get her law passed in Maine, prescription drug deaths jumped to over 160 per year. In Maine, every day, a baby is born addicted to prescription drugs. Those rates have only continued to climb. Just last week, the Federal Government noted that Maine has the worst prescription drug abuse problem in the country. So, the Supreme Court can take its time – Sharon Treat and the NLARx have already won…and the bodies are piling up in Maine to prove that I’m right.
Saturday, April 23, 2011
J&J Recalls Topamax Epilepsy Drug
Last week, Johnson & Johnson issued is nth (I’ve lost count, we’re well above 50 now) for the anti-epilepsy drug Topamax. As it turns out, the Topamax product has the same musty order as other products which have been contaminated with the pesticide 2,4,6-tribromoanisole (TBA).
The recall effects Topamax that was manufactured and shipped between October 19, 2010 and December 28, 2010. No word from J&J on why it waited over 4 months to initiate the recall.
No word from J&J on how this happened. Topamax is manufactured at an entirely different plant in Puerto Rico that has not previously seen manufacturing problems and is not covered by J&J’s consent decree with the FDA.
Remember the quote from the great J&J CEO William Weldon in which he said there are no systemic problems at J&J? Remember that? Help me out here – if you have the same problem at different J&J manufacturing plants, run by different J&J operating companies, under different leadership, with supposedly different quality organizations, and all of this in different countries which all yield the same result – is that not by definition a SYSTEMIC problem? Let’s review Weldon’s quote: “I think that everything has been overshadowed by one company [McNeil]” and continues by saying, “This is not a systemic problem. This is not an issue around J&J.” William Weldon is either engaging in bold face lies for the sake of his (massive) personal bonus or else he’s too stupid to understand what a systemic problem actually is. If J&J ever has a hope at recovery, it needs to dump the albatross of William Weldon.
The recall effects Topamax that was manufactured and shipped between October 19, 2010 and December 28, 2010. No word from J&J on why it waited over 4 months to initiate the recall.
No word from J&J on how this happened. Topamax is manufactured at an entirely different plant in Puerto Rico that has not previously seen manufacturing problems and is not covered by J&J’s consent decree with the FDA.
Remember the quote from the great J&J CEO William Weldon in which he said there are no systemic problems at J&J? Remember that? Help me out here – if you have the same problem at different J&J manufacturing plants, run by different J&J operating companies, under different leadership, with supposedly different quality organizations, and all of this in different countries which all yield the same result – is that not by definition a SYSTEMIC problem? Let’s review Weldon’s quote: “I think that everything has been overshadowed by one company [McNeil]” and continues by saying, “This is not a systemic problem. This is not an issue around J&J.” William Weldon is either engaging in bold face lies for the sake of his (massive) personal bonus or else he’s too stupid to understand what a systemic problem actually is. If J&J ever has a hope at recovery, it needs to dump the albatross of William Weldon.
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