Latest Drugwonks' Blog
Ed Silverman, the brains behind pharmalot ( www.pharmalot.com) has written a great piece on the trend towards patient reported outcomes in clinical trials. Must reading on this subject for anyone interested in personalized medicine and understanding how and why FDA yanked the QOL indications from Amgen's anemia drugs.
http://www.the-scientist.com/article/home/53617/
Now it seems that accessing this data can often be a problem for the researchers who want to use this research to find out what works. An editorial in JAMA by Norman Frost of the Univ of Wisc. Medical School writes that application of HIPAA rules has shut down research or scared off otherwise important studies in the name of privacy:
"The sources of these problems include Office for Human Research Protection and the FDA because they appear to threaten institutions with draconian penalties for minor infractions; institutional (university and other) administrators acting out of fear that their institution could be the next to have its entire research operation suspended by 'getting caught' in one of these minor infractions; and credentialing and certifying agencies for supporting these excesses by including them in their criteria for accreditation."
http://www.sciencedaily.com/releases/2007/11/071113165648.htm
http://www.the-scientist.com/article/home/53617/
Now it seems that accessing this data can often be a problem for the researchers who want to use this research to find out what works. An editorial in JAMA by Norman Frost of the Univ of Wisc. Medical School writes that application of HIPAA rules has shut down research or scared off otherwise important studies in the name of privacy:
"The sources of these problems include Office for Human Research Protection and the FDA because they appear to threaten institutions with draconian penalties for minor infractions; institutional (university and other) administrators acting out of fear that their institution could be the next to have its entire research operation suspended by 'getting caught' in one of these minor infractions; and credentialing and certifying agencies for supporting these excesses by including them in their criteria for accreditation."
http://www.sciencedaily.com/releases/2007/11/071113165648.htm
Here's USA Today crawling through the mud -- past Janet Woodcock who officially speaks for the FDA -- to talk to David Graham about Avandia:
"This is a warning that's not a warning," said Graham, speaking for himself. "The other thing that's missing is a statement that … there are other alternatives available that work as well as Avandia and don't have this cloud hanging over them."
So Graham wants the FDA to engage in comparative effectiveness which is clearly not it's statutory authority and for which there is no evidence anyways that could be slapped on a label. USA Today runs with this statement instead of the scientific one made by Dr. Woodcock based on the evidence.
No wonder patients are confused and afraid.
http://www.usatoday.com/news/health/2007-11-14-diabetes-heart_N.htm?loc=interstitialskip
"This is a warning that's not a warning," said Graham, speaking for himself. "The other thing that's missing is a statement that … there are other alternatives available that work as well as Avandia and don't have this cloud hanging over them."
So Graham wants the FDA to engage in comparative effectiveness which is clearly not it's statutory authority and for which there is no evidence anyways that could be slapped on a label. USA Today runs with this statement instead of the scientific one made by Dr. Woodcock based on the evidence.
No wonder patients are confused and afraid.
http://www.usatoday.com/news/health/2007-11-14-diabetes-heart_N.htm?loc=interstitialskip
Forget the black box for now..here's FDA's Janet Woodcock speaking clearly and confidently on what the agency decided and what the new labeling means:
"We are keeping Avandia on the market because we have concluded that there is not enough evidence to conclude that the risk for heart attack or cardiac ischemia is higher than for other type-2 diabetes drugs," the FDA's Dr. Janet Woodcock told reporters in a phone briefing.
The studies have been inconclusive and those that appear to show a risk all compare Avandia to a placebo, she said."
Thus the FDA is closer to the European Medicine Agency than Canada. I am keeping a count to see how many news accounts or blogs note that the EMEA kept Avandia on the market without relabeling. Big zero so far.
http://www.reuters.com/article/governmentFilingsNews/idUSN1421392120071114
"We are keeping Avandia on the market because we have concluded that there is not enough evidence to conclude that the risk for heart attack or cardiac ischemia is higher than for other type-2 diabetes drugs," the FDA's Dr. Janet Woodcock told reporters in a phone briefing.
The studies have been inconclusive and those that appear to show a risk all compare Avandia to a placebo, she said."
Thus the FDA is closer to the European Medicine Agency than Canada. I am keeping a count to see how many news accounts or blogs note that the EMEA kept Avandia on the market without relabeling. Big zero so far.
http://www.reuters.com/article/governmentFilingsNews/idUSN1421392120071114
John Edwards must know something -- like his campaign is dying. Why else would he decide to jump on the bandwagon of Bernie Sanders (the Senator from Ben & Jerry's) and come out in support of the year's worst idea in health care reform -- prizes rather than patents.
Here's what Senator Edwards had to say to a group of medical professionals at Dartmouth-Hitchcock Medical Center on the subject of prizes for pharmaceutical innovation:
"It would also create a different dynamic for drug companies and particularly for breakthrough drugs in big areas like Alzheimer’s, cancer, etc. We’d offer a cash prize for the research and development of these drugs, but they don’t get a patent. So we eliminate the monopoly…The idea is you’ve got to give the financial incentive for the companies to do it but on the flip side you get the products to the market quicker, available quickly and at a much lower cost.â€
Okay -- once more with feeling -- this is just not true. As Joe DiMasi (Tufts University) and Henry Grabowski (Duke University) have argued, under a prize program, pharmaceutical innovators would lack the incentive to innovate. To quote DiMasi and Grabowski, “The dynamic benefits created by patents on pharmaceuticals can, and almost surely do, swamp in significance their short-run inefficiencies.â€
For more reasons this is a crackpot idea see our October 22nd blog entry ("Et tu, Bernie") here:
http://drugwonks.com/2007/10/et_tu_bernie.html
Note to Senator Edwards: You should look into how much money is currently being spent by the biopharmaceutical industry on Alzheimer's research and development. (We assume you have already done so on the issue of breast cancer.)
Here's what Senator Edwards had to say to a group of medical professionals at Dartmouth-Hitchcock Medical Center on the subject of prizes for pharmaceutical innovation:
"It would also create a different dynamic for drug companies and particularly for breakthrough drugs in big areas like Alzheimer’s, cancer, etc. We’d offer a cash prize for the research and development of these drugs, but they don’t get a patent. So we eliminate the monopoly…The idea is you’ve got to give the financial incentive for the companies to do it but on the flip side you get the products to the market quicker, available quickly and at a much lower cost.â€
Okay -- once more with feeling -- this is just not true. As Joe DiMasi (Tufts University) and Henry Grabowski (Duke University) have argued, under a prize program, pharmaceutical innovators would lack the incentive to innovate. To quote DiMasi and Grabowski, “The dynamic benefits created by patents on pharmaceuticals can, and almost surely do, swamp in significance their short-run inefficiencies.â€
For more reasons this is a crackpot idea see our October 22nd blog entry ("Et tu, Bernie") here:
http://drugwonks.com/2007/10/et_tu_bernie.html
Note to Senator Edwards: You should look into how much money is currently being spent by the biopharmaceutical industry on Alzheimer's research and development. (We assume you have already done so on the issue of breast cancer.)
On March 29th, CMPI and Old Dominion University sponsored a conference on evidence-based medicine and its implications for a cost-centric vs. patient-focused health care future.
Speakers included Carolyn Clancy (AHRQ), Gail Wilensky (Project Hope), Scott Gottlieb (AEI), John Bridges (Johns Hopkins), Peter Elkn (Mayo Clinic), among others.
Here is the final report on the event -- and it's really must reading for anyone concerned about the precarious balance between value and quality -- in short, the future of the American health care system.
Here's a link to the final report:
http://cmpi.org/archives/2007/11/improving_health_care_quality.php
Here's an enticing tidbit from the conclusion of the report ...
"We're not at the end of this debate. We're not at the beginning of the end of this debate. But we are at the end of the beginning where at least we can all agree that this is not, and must not be exclusively a debate about saving money. It must be about patient care."
An important read.
Speakers included Carolyn Clancy (AHRQ), Gail Wilensky (Project Hope), Scott Gottlieb (AEI), John Bridges (Johns Hopkins), Peter Elkn (Mayo Clinic), among others.
Here is the final report on the event -- and it's really must reading for anyone concerned about the precarious balance between value and quality -- in short, the future of the American health care system.
Here's a link to the final report:
http://cmpi.org/archives/2007/11/improving_health_care_quality.php
Here's an enticing tidbit from the conclusion of the report ...
"We're not at the end of this debate. We're not at the beginning of the end of this debate. But we are at the end of the beginning where at least we can all agree that this is not, and must not be exclusively a debate about saving money. It must be about patient care."
An important read.
MRSA slowing spreading to the community. No drugs in the pipeline in large part to Congressman Waxman's jihad against using clinical trial designs that have brought HIV drugs to market to accelerate approval of medicines for MRSA that kill more people than HIV. Waxman's response? Read his sanctimonious speech on infectious disease control which essentially urges everyone to wash their hands.
http://oversight.house.gov/story.asp?ID=1606
Read this article on how Waxman's attack has helped kill investment and scared the FDA into inferior antibiotic drug approval rates.
http://www.morgenthaler.com/.../Ventures/Articles/
http://oversight.house.gov/story.asp?ID=1606
Read this article on how Waxman's attack has helped kill investment and scared the FDA into inferior antibiotic drug approval rates.
http://www.morgenthaler.com/.../Ventures/Articles/
People who rob banks only steal money. And they only steal it once. But when intellectual property is stolen, the rip-off is ongoing -- and the results can be deadly.
Today, one of the biggest rip-offs going threatens to cripple the U.S. pharmaceutical industry, which faces unprecedented losses from the theft of intellectual property via the mass production of copycat drugs. These drugs are manufactured in places like China, the former Soviet Union, the Philippines and other places where the U.S. Food and Drug Administration has no effective oversight authority — and where the safeguards designed to protect public health taken for granted in America are virtually nonexistent.
Amazingly, some lawmakers in Congress don't recognize the extent of the threat, and are pushing legislation that would make it legal to import prescription drugs from abroad.
Such a measure would lead to a deluge of copycats entering the legitimate supply chain, since it would be virtually impossible to track what's real and prevent phony medications from entering the U.S. market.
Senator Bernie Sanders (I, B&J -- Ben and Jerry's) is fond of taunting the opponents of drug importation by asking, "Where are all the dead Canadians?" Unfortunately, the most recent answer to this question is -- Quadra Insland.
Earlier this year in Canada, a woman who purchased Xanax and Ambien from what she thought was an online Canadian pharmacy died after taking her pills. It turns out the drugs were fake — and were filled with aluminum, tin and even arsenic. They had actually been purchased from a Web site in the Czech Republic and produced in Southeast Asia. But because the medication, in all likelihood, came with labeling and packaging that was indistinguishable from the real thing, there was no way for the victim to know her pills were contaminated with dangerous impurities.
Toxicology tests found three well-known drugs in her system: alprazolam -- more commonly recognized as the anti-anxiety drug Xanax; zolpidem -- which most are acquainted with as the brand-name sleeping pill Ambien; and acetaminophen. Zolpidem is not available in Canada, so it's understandable why Bergeron turned to the internet to try to get the drug.
As the prevalence of counterfeit drugs increases, the long-term viability of legitimate pharmaceutical companies is threatened.
Estimates vary, but the cost of developing a new drug ranges from a low of around $800 million to as much as $2 billion. Much of that investment goes to cover the cost of clinical trials to assure the new drugs are safe and to meet the federal government's many regulations.
Copycats, of course, don't have to worry about any of that; they just take the proverbial ball and run with it — straight to the bank. In fact, it's estimated that counterfeit drug sales will account for $75 billion globally by 2010. According to a recent article in U.S. News & World Report, the counterfeit drug trade is already worth some $35 billion annually.
Anyone who doubts the effect such losses have — both in real terms today and in how the American pharmaceutical industry chooses to invest its dollars and its human talent tomorrow — must have slept through Econ 101.
Here's the rest of the story from today's edition of the Florida Sun-Sentinel:
http://www.sun-sentinel.com/news/opinion/sfl-copycat13forumnbnov13,0,2801251.story
Opening the floodgates to imported drugs of unknown origin is a terrifying proposition. It poses a real risk today, and it threatens our health and well-being tomorrow
Today, one of the biggest rip-offs going threatens to cripple the U.S. pharmaceutical industry, which faces unprecedented losses from the theft of intellectual property via the mass production of copycat drugs. These drugs are manufactured in places like China, the former Soviet Union, the Philippines and other places where the U.S. Food and Drug Administration has no effective oversight authority — and where the safeguards designed to protect public health taken for granted in America are virtually nonexistent.
Amazingly, some lawmakers in Congress don't recognize the extent of the threat, and are pushing legislation that would make it legal to import prescription drugs from abroad.
Such a measure would lead to a deluge of copycats entering the legitimate supply chain, since it would be virtually impossible to track what's real and prevent phony medications from entering the U.S. market.
Senator Bernie Sanders (I, B&J -- Ben and Jerry's) is fond of taunting the opponents of drug importation by asking, "Where are all the dead Canadians?" Unfortunately, the most recent answer to this question is -- Quadra Insland.
Earlier this year in Canada, a woman who purchased Xanax and Ambien from what she thought was an online Canadian pharmacy died after taking her pills. It turns out the drugs were fake — and were filled with aluminum, tin and even arsenic. They had actually been purchased from a Web site in the Czech Republic and produced in Southeast Asia. But because the medication, in all likelihood, came with labeling and packaging that was indistinguishable from the real thing, there was no way for the victim to know her pills were contaminated with dangerous impurities.
Toxicology tests found three well-known drugs in her system: alprazolam -- more commonly recognized as the anti-anxiety drug Xanax; zolpidem -- which most are acquainted with as the brand-name sleeping pill Ambien; and acetaminophen. Zolpidem is not available in Canada, so it's understandable why Bergeron turned to the internet to try to get the drug.
As the prevalence of counterfeit drugs increases, the long-term viability of legitimate pharmaceutical companies is threatened.
Estimates vary, but the cost of developing a new drug ranges from a low of around $800 million to as much as $2 billion. Much of that investment goes to cover the cost of clinical trials to assure the new drugs are safe and to meet the federal government's many regulations.
Copycats, of course, don't have to worry about any of that; they just take the proverbial ball and run with it — straight to the bank. In fact, it's estimated that counterfeit drug sales will account for $75 billion globally by 2010. According to a recent article in U.S. News & World Report, the counterfeit drug trade is already worth some $35 billion annually.
Anyone who doubts the effect such losses have — both in real terms today and in how the American pharmaceutical industry chooses to invest its dollars and its human talent tomorrow — must have slept through Econ 101.
Here's the rest of the story from today's edition of the Florida Sun-Sentinel:
http://www.sun-sentinel.com/news/opinion/sfl-copycat13forumnbnov13,0,2801251.story
Opening the floodgates to imported drugs of unknown origin is a terrifying proposition. It poses a real risk today, and it threatens our health and well-being tomorrow
Here's the straight story:
Preschoolers With Three or More Coexisting Disorders Show No Response to ADHD Medication Treatment
BETHESDA, MD -- November 5, 2007 -- Preschoolers who are diagnosed with attention-deficit hyperactivity disorder (ADHD) are not likely to respond to treatment with the stimulant methylphenidate, regardless of dosage, if they also have three or more coexisting disorders, according to a recent analysis of data from the Preschoolers with ADHD Treatment Study (PATS).
Previously reported PATS results showed that overall, low doses of methylphenidate were safe and effective in treating 3-5-year-olds diagnosed with ADHD.
This most recent study, one of seven new PATS articles published November 5, 2007, in the Journal of Child and Adolescent Psychopharmacology, sought to identify individual characteristics that may affect how a child would respond to treatment. The other articles examine topics such as the effectiveness of methylphenidate over a follow-up phase, the effects of the medication on functional outcomes for the preschoolers, and others.
"This new data is an important step forward in bridging the gap between research results and clinical practice, bringing potentially valuable information to clinicians about ways to better customize treatments for their patients," said NIMH Director Thomas R. Insel, MD. "It also identifies a group of young children who have significant and multiple problems, and for whom more research is needed to identify effective treatments."
http://www.docguide.com/news/content.nsf/news/852571020057CCF68525738A0075CA73
Here is how the media mangled and engaged in fear mongering right off the bat:
BBC
Drugs for ADHD 'not the answer'Treating children who have Attention Deficit Hyperactivity Disorder (ADHD) with drugs is not effective in the long-term, research has shown.
FoxNews.com
" Drugs used to treat attention deficit hyperactivity disorder (ADHD) have no long-term effectiveness and could stunt your child's growth, News.com.au is reporting.
And scientists have conceded that test results that prompted the parental craze to dole out the drugs to their kids, may have been exaggerated.
In what is sure to generate debate, BBC's Panorama program Sunday aired the results of a long-term monitoring program of 600 children across the U.S. since the early 1990's.
The Multimodal Treatment Study of Children with ADHD study concluded that while drugs such as Ritalin and Concerta worked in the short term, there was no demonstrable improvement in children's behavior after three years of medication."
FoxNews.com uses the BBC as the authority! Parental craze...not too much editorializing.
Disgusting.
http://www.foxnews.com/story/0,2933,310596,00.html
http://news.bbc.co.uk/2/hi/uk_news/7090011.stm
Preschoolers With Three or More Coexisting Disorders Show No Response to ADHD Medication Treatment
BETHESDA, MD -- November 5, 2007 -- Preschoolers who are diagnosed with attention-deficit hyperactivity disorder (ADHD) are not likely to respond to treatment with the stimulant methylphenidate, regardless of dosage, if they also have three or more coexisting disorders, according to a recent analysis of data from the Preschoolers with ADHD Treatment Study (PATS).
Previously reported PATS results showed that overall, low doses of methylphenidate were safe and effective in treating 3-5-year-olds diagnosed with ADHD.
This most recent study, one of seven new PATS articles published November 5, 2007, in the Journal of Child and Adolescent Psychopharmacology, sought to identify individual characteristics that may affect how a child would respond to treatment. The other articles examine topics such as the effectiveness of methylphenidate over a follow-up phase, the effects of the medication on functional outcomes for the preschoolers, and others.
"This new data is an important step forward in bridging the gap between research results and clinical practice, bringing potentially valuable information to clinicians about ways to better customize treatments for their patients," said NIMH Director Thomas R. Insel, MD. "It also identifies a group of young children who have significant and multiple problems, and for whom more research is needed to identify effective treatments."
http://www.docguide.com/news/content.nsf/news/852571020057CCF68525738A0075CA73
Here is how the media mangled and engaged in fear mongering right off the bat:
BBC
Drugs for ADHD 'not the answer'Treating children who have Attention Deficit Hyperactivity Disorder (ADHD) with drugs is not effective in the long-term, research has shown.
FoxNews.com
" Drugs used to treat attention deficit hyperactivity disorder (ADHD) have no long-term effectiveness and could stunt your child's growth, News.com.au is reporting.
And scientists have conceded that test results that prompted the parental craze to dole out the drugs to their kids, may have been exaggerated.
In what is sure to generate debate, BBC's Panorama program Sunday aired the results of a long-term monitoring program of 600 children across the U.S. since the early 1990's.
The Multimodal Treatment Study of Children with ADHD study concluded that while drugs such as Ritalin and Concerta worked in the short term, there was no demonstrable improvement in children's behavior after three years of medication."
FoxNews.com uses the BBC as the authority! Parental craze...not too much editorializing.
Disgusting.
http://www.foxnews.com/story/0,2933,310596,00.html
http://news.bbc.co.uk/2/hi/uk_news/7090011.stm
A year after safety questions about drug-coated heart stents prompted doctors to change treatment for hundreds of thousands of cardiac patients, many physicians say the medical community overreacted and should now reverse course.
The alarm was caused by medical studies suggesting that drug-coated stents might be causing deadly blood clots. But with benefit of additional data and further analysis, many doctors say drug-coated stents may not be so risky after all, at least compared with various alternatives whose drawbacks may outweigh the risks of clotting.
Because the safety fears were widespread, however, even those rooting hardest for a rebound — the companies that make stents — are not expecting a quick resurgence for the drug-coated devices. Worldwide, stent sales have fallen by about $1 billion since last year, to $5 billion this year."
The alarm was not caused by the studies but by media accounts that ignored dozens of other studies and the absolute risk of death followed by trial lawyers fanning flames of fear...
From an Oct 21 2006 article by Feder
Doctors Rethink Widespread Use of Heart Stents
..."But now stent sales are falling and some doctors are rethinking their faith in the devices, driven by emerging evidence that the newest and most common type — drug-coated stents — can sometimes cause potentially fatal blood clots months or even years after they are implanted.
The Food and Drug Administration said yesterday that it would hold hearings in early December to consider whether to issue new stent safety guidelines.
The evidence indicates that overuse of stents may be leading to thousands of heart attacks and deaths each year, whether because stents are being used in relatively mild cases where drugs should be prescribed instead, or because patients are receiving drug-coated versions where simpler, cheaper bare-metal devices might work just as well.
There is no question that stents have saved countless lives in the short term by preventing impending heart attacks or opening arteries while an attack is being treated. But neither type of stent, no matter how much better it may make a patient feel, has been shown in rigorous clinical trials to improve long-term survival compared with other forms of treatment.
“In the past we’d say, ‘Why not?,’ †said Dr. William O’Neill, a well-known cardiologist at the University of Miami and longtime advocate of using drug-coated stents. But the new safety data, he said, amounts to “a big why not†for many patients.
The new evidence has added to a long-simmering debate over whether doctors have been too quick to prescribe stenting — whether because drugs would work as well for healthier patients or because bypass surgery might help the sickest ones live longer."
http://www.nytimes.com/2006/10/21/business/21stent.html?ex=1319083200&en=0ad3debe72a4dc90&ei=5088&partner=rssnyt&emc=rss
http://www.nytimes.com/2007/11/12/health/research/12stent.html?n=Top/Reference/Times%20Topics/People/F/Feder,%20Barnaby%20J.
The alarm was caused by medical studies suggesting that drug-coated stents might be causing deadly blood clots. But with benefit of additional data and further analysis, many doctors say drug-coated stents may not be so risky after all, at least compared with various alternatives whose drawbacks may outweigh the risks of clotting.
Because the safety fears were widespread, however, even those rooting hardest for a rebound — the companies that make stents — are not expecting a quick resurgence for the drug-coated devices. Worldwide, stent sales have fallen by about $1 billion since last year, to $5 billion this year."
The alarm was not caused by the studies but by media accounts that ignored dozens of other studies and the absolute risk of death followed by trial lawyers fanning flames of fear...
From an Oct 21 2006 article by Feder
Doctors Rethink Widespread Use of Heart Stents
..."But now stent sales are falling and some doctors are rethinking their faith in the devices, driven by emerging evidence that the newest and most common type — drug-coated stents — can sometimes cause potentially fatal blood clots months or even years after they are implanted.
The Food and Drug Administration said yesterday that it would hold hearings in early December to consider whether to issue new stent safety guidelines.
The evidence indicates that overuse of stents may be leading to thousands of heart attacks and deaths each year, whether because stents are being used in relatively mild cases where drugs should be prescribed instead, or because patients are receiving drug-coated versions where simpler, cheaper bare-metal devices might work just as well.
There is no question that stents have saved countless lives in the short term by preventing impending heart attacks or opening arteries while an attack is being treated. But neither type of stent, no matter how much better it may make a patient feel, has been shown in rigorous clinical trials to improve long-term survival compared with other forms of treatment.
“In the past we’d say, ‘Why not?,’ †said Dr. William O’Neill, a well-known cardiologist at the University of Miami and longtime advocate of using drug-coated stents. But the new safety data, he said, amounts to “a big why not†for many patients.
The new evidence has added to a long-simmering debate over whether doctors have been too quick to prescribe stenting — whether because drugs would work as well for healthier patients or because bypass surgery might help the sickest ones live longer."
http://www.nytimes.com/2006/10/21/business/21stent.html?ex=1319083200&en=0ad3debe72a4dc90&ei=5088&partner=rssnyt&emc=rss
http://www.nytimes.com/2007/11/12/health/research/12stent.html?n=Top/Reference/Times%20Topics/People/F/Feder,%20Barnaby%20J.
Advising policy-makers, taking on pundits, and fighting the good fight for patient-centric medicine is one thing -- getting quoted in Sports Illustrated is something else. Here's story that talks about how one-time Yankee great Mel Stottlemyre has had his life returned to him because of the miracles of modern medicine.
'Strong as a horse'
Treatment allows Stottlemyre to return to baseball
SEATTLE (AP) -- Mel Stottlemyre was getting his white blood cells counted for yet another month. Unsolicited, his doctor said he could go back to full-time work again, back to the ballpark routine he had followed just about every summer for 41 years.
Then came another unexpected offer.
Stottlemyre returned to the major leagues this week as the pitching coach of the Seattle Mariners, accepting the first of what he hopes is a series of one-year contracts. It's the only job that could get him back into a dugout.
"I certainly hope it lasts for more than one year," Stottlemyre said. "Whatever happens, at my age and certainly with my health issue, I'm excited for the opportunity."
The 65-year-old former pitching coach for the Yankees and Mets got cleared to return to the bigs during a visit to his Seattle-area doctor this summer. Just as she had each month for years, the doctor told Stottlemyre his blood-cell count would allow him resume the three-weeks on, one-week off pill cycle he takes to combat multiple myeloma.
But this time, she surprised the old right-hander-turned-fisherman.
"You have no restrictions to go back to work full time, if you want," she told him a few months ago.
"I wasn't even looking for that," Stottlemyre said Monday night.
The former five-time All-Star with the Yankees left them in 2005, after 10 seasons and four World Series titles as New York's pitching coach. He said he was tired of criticism from owner George Steinbrenner. Raised in Mabton, Wash., he returned to his home in the Seattle suburb of Issaquah and interviewed that fall to become manager Mike Hargrove's pitching coach with the Mariners. Hargrove chose relatively inexperienced Rafael Chaves instead.
Stottlemyre dabbled in spring training and instructional league work with the Arizona Diamondbacks last year. He golfed, fished and helped his son Todd, one of two sons who also pitched in the majors, begin his new career as a financial adviser.
One of the first clients he lined up for Todd was John McLaren, the Mariners bench coach who became manager when Hargrove abruptly resigned July 1.
The dividends from that arrangement arrived this month. McLaren called to ask Stottlemyre to replace Chaves, after Seattle's starters had a 5.12 ERA this past season -- 12th in the AL. They were the main reason for the remarkable September collapse that doomed Seattle's unlikely contention for a playof spo.
"Mel was my No. 1 choice," McLaren said. "His reputation speaks for itself."
Stottlemyre was content fishing and golfing.
"I wasn't really anxious to get back into the game -- until the Seattle job came open," Stottlemyre said. "I've always wondered what it would be like to be in baseball but still be able to come home every day."
McLaren had been golfing with Stottlemyre over the last year and noticed that his friend's health was not an issue.
"I sure wouldn't want to mess with Mel. He's strong as a horse," McLaren said.
Stottlemye credits the cancer drug lenalidomide, marketed under the brand name Revlimid, for repelling his disease. Revlimid isn't for everyone. Its retail price can reach $6,400 a month, according to the Center for Medicine in the Public Interest.
"It's very expensive, but it's very effective," Stottlemyre said. "With the type of cancer I've had it's something where they never use the word 'cure.' Right now, it's not curable. It's treatable.
"I'm doing absolutely super. I have no signs of the disease. I wouldn't call it a 'remission' so much as I would say that I'm on a tremendous maintenance program."
Stottlemyre will have a far different pitching staff than the one he enjoyed with the Yankees. Instead of tutoring the likes of Roger Clemens, Mike Mussina and Andy Pettitte, he'll be demanding that Seattle's 21-year-old ace Felix Hernandez plus veteran holdovers Jarro Washburn and Miguel Batista pitch inside more -- something Stottlemyre focuses on. He also will advise McLaren and general manager Bill Bavasi as they seek another veteran starter this winter.
"At first glance, I see a very challenging job," Stottlemyre said of his new group of pitchers. "I hope that I have something to add to each that will help each one."
Talk about personalized!
'Strong as a horse'
Treatment allows Stottlemyre to return to baseball
SEATTLE (AP) -- Mel Stottlemyre was getting his white blood cells counted for yet another month. Unsolicited, his doctor said he could go back to full-time work again, back to the ballpark routine he had followed just about every summer for 41 years.
Then came another unexpected offer.
Stottlemyre returned to the major leagues this week as the pitching coach of the Seattle Mariners, accepting the first of what he hopes is a series of one-year contracts. It's the only job that could get him back into a dugout.
"I certainly hope it lasts for more than one year," Stottlemyre said. "Whatever happens, at my age and certainly with my health issue, I'm excited for the opportunity."
The 65-year-old former pitching coach for the Yankees and Mets got cleared to return to the bigs during a visit to his Seattle-area doctor this summer. Just as she had each month for years, the doctor told Stottlemyre his blood-cell count would allow him resume the three-weeks on, one-week off pill cycle he takes to combat multiple myeloma.
But this time, she surprised the old right-hander-turned-fisherman.
"You have no restrictions to go back to work full time, if you want," she told him a few months ago.
"I wasn't even looking for that," Stottlemyre said Monday night.
The former five-time All-Star with the Yankees left them in 2005, after 10 seasons and four World Series titles as New York's pitching coach. He said he was tired of criticism from owner George Steinbrenner. Raised in Mabton, Wash., he returned to his home in the Seattle suburb of Issaquah and interviewed that fall to become manager Mike Hargrove's pitching coach with the Mariners. Hargrove chose relatively inexperienced Rafael Chaves instead.
Stottlemyre dabbled in spring training and instructional league work with the Arizona Diamondbacks last year. He golfed, fished and helped his son Todd, one of two sons who also pitched in the majors, begin his new career as a financial adviser.
One of the first clients he lined up for Todd was John McLaren, the Mariners bench coach who became manager when Hargrove abruptly resigned July 1.
The dividends from that arrangement arrived this month. McLaren called to ask Stottlemyre to replace Chaves, after Seattle's starters had a 5.12 ERA this past season -- 12th in the AL. They were the main reason for the remarkable September collapse that doomed Seattle's unlikely contention for a playof spo.
"Mel was my No. 1 choice," McLaren said. "His reputation speaks for itself."
Stottlemyre was content fishing and golfing.
"I wasn't really anxious to get back into the game -- until the Seattle job came open," Stottlemyre said. "I've always wondered what it would be like to be in baseball but still be able to come home every day."
McLaren had been golfing with Stottlemyre over the last year and noticed that his friend's health was not an issue.
"I sure wouldn't want to mess with Mel. He's strong as a horse," McLaren said.
Stottlemye credits the cancer drug lenalidomide, marketed under the brand name Revlimid, for repelling his disease. Revlimid isn't for everyone. Its retail price can reach $6,400 a month, according to the Center for Medicine in the Public Interest.
"It's very expensive, but it's very effective," Stottlemyre said. "With the type of cancer I've had it's something where they never use the word 'cure.' Right now, it's not curable. It's treatable.
"I'm doing absolutely super. I have no signs of the disease. I wouldn't call it a 'remission' so much as I would say that I'm on a tremendous maintenance program."
Stottlemyre will have a far different pitching staff than the one he enjoyed with the Yankees. Instead of tutoring the likes of Roger Clemens, Mike Mussina and Andy Pettitte, he'll be demanding that Seattle's 21-year-old ace Felix Hernandez plus veteran holdovers Jarro Washburn and Miguel Batista pitch inside more -- something Stottlemyre focuses on. He also will advise McLaren and general manager Bill Bavasi as they seek another veteran starter this winter.
"At first glance, I see a very challenging job," Stottlemyre said of his new group of pitchers. "I hope that I have something to add to each that will help each one."
Talk about personalized!
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
