Latest Drugwonks' Blog
I received this email from a friend of mine...
"I saw Dr. Scott Gottlieb again today at a meeting of the Food and Drug Law Institute (FDLI). The topic was "Whose Life is it anyway?" and they talked about the Abigail Alliance's lawsuit for earlier access to experimental drugs. Scott gave an appalling example of regulatory creep where the clinical trials for a drug for Hunter's syndrome (one of the mucopolysaccharide diseases) required 100 patients and randomized controlled trial with endpoints being abilty to walk and abilty to breathe! Since it is very rare, he said that the trial likely had to enroll a portion of the world's population in the trial to meet the numbers! He contrasted this with the agency's approval of Cerezyme last decade with about 20 patients! I left the meeting feeling very passionate about the need to do something about regulatory creep and bring more rational clinical trial design to the agency - all of which Scott espoused."
I hope it is not too late...
This latest outrage is just a taste of what's to come under Kennedy-Enzi, Dingell, Stupak, Markey, Waxman, Grassley, Graham, IOM and the coverage thereof of 12 liver problems regarding Ketek hath wrought.... slower cures, fewer drugs, Steve Nissen's god-posturing on cardiovascular problems associated with ADHD drugs,claims that schizophrenia drugs are the next Ketek (meaning the next show trials, which means the next decline in use of drugs for mental illness which will mean another spike in suicides)..
Do any of these preening posturing types care about those who are dying? No, they are too busy trying to explain how watered down biologic standards will produce lifesaving medicines while slowing down orphan drug approvals won't. There are few in official Washington with any passion on this issue. Janet Woodcock of the FDA, Greg Simon of Faster Cures, Frank Burroughs of the Abigail Alliance, Ellen Sigal of Friends of Cancer...The rest could just as well be names drawn from the DC phone directory or in the case of NORD, just a big fat obstacle to change. In fact, NORD should stand for No Orphan Research and Development....
Sorry, just a bad morning.
"I saw Dr. Scott Gottlieb again today at a meeting of the Food and Drug Law Institute (FDLI). The topic was "Whose Life is it anyway?" and they talked about the Abigail Alliance's lawsuit for earlier access to experimental drugs. Scott gave an appalling example of regulatory creep where the clinical trials for a drug for Hunter's syndrome (one of the mucopolysaccharide diseases) required 100 patients and randomized controlled trial with endpoints being abilty to walk and abilty to breathe! Since it is very rare, he said that the trial likely had to enroll a portion of the world's population in the trial to meet the numbers! He contrasted this with the agency's approval of Cerezyme last decade with about 20 patients! I left the meeting feeling very passionate about the need to do something about regulatory creep and bring more rational clinical trial design to the agency - all of which Scott espoused."
I hope it is not too late...
This latest outrage is just a taste of what's to come under Kennedy-Enzi, Dingell, Stupak, Markey, Waxman, Grassley, Graham, IOM and the coverage thereof of 12 liver problems regarding Ketek hath wrought.... slower cures, fewer drugs, Steve Nissen's god-posturing on cardiovascular problems associated with ADHD drugs,claims that schizophrenia drugs are the next Ketek (meaning the next show trials, which means the next decline in use of drugs for mental illness which will mean another spike in suicides)..
Do any of these preening posturing types care about those who are dying? No, they are too busy trying to explain how watered down biologic standards will produce lifesaving medicines while slowing down orphan drug approvals won't. There are few in official Washington with any passion on this issue. Janet Woodcock of the FDA, Greg Simon of Faster Cures, Frank Burroughs of the Abigail Alliance, Ellen Sigal of Friends of Cancer...The rest could just as well be names drawn from the DC phone directory or in the case of NORD, just a big fat obstacle to change. In fact, NORD should stand for No Orphan Research and Development....
Sorry, just a bad morning.
Some of the worst reporting on health surrounds the relative and absolute risks and benefits about medicines. Case in point is the HPV vaccine. As our friend NYU internist and author Mark Siegel points out, the reason for making the vaccine mandatory has less to do with reducing cancer, important on its own, but also genital herpes, abnormal pap smears and other public health problems...
"The problem with combating the human papilloma virus in the United States isn't only cervical cancer or precancerous cells. The problem also is an epidemic of sexually transmitted genital warts. The CDC says HPV causes more than 6 million new cases of genital warts in this country every year.
There are many cases in medical history where vaccination has proved extremely effective in promoting public health even in the face of possible side effects."
http://www.newsday.com/news/printedition/opinion/ny-opsie205101066feb20,0,3529854.story?coll=ny-opinion-print
The coverage of a recent data dredging effort looking at the RELATIVE RISKS of taking different painkillers and high blood pressures for the most part failed to make the qualifications the researchers did. (This was a study of heavy, obese males in the main who were frequent users of all sorts of pain killers against non users that did not control for any other medications) The increase in risk of 33 percent was an increase in risk from 1 percent to 1.36 percent. Leave to scaremonger at the Washington Post
Shankar Vedantam to write a story with the headline : Doctors Warned About Common Drugs for Pain NSAIDs Tied to Risk of Heart Attack, Stroke... Aargh..
But Seniorjournal.com saves the day with straightforward reporting that just gives the facts without the unscientific spin that shady Shankar always seems to give to his stories:
Older Men Regularly Taking Over-the-Counter Pain Relievers have Risk of High Blood Pressure
http://www.seniorjournal.com/NEWS/Health/2007/7-02-26-OlderMenRegularly.htm
"The problem with combating the human papilloma virus in the United States isn't only cervical cancer or precancerous cells. The problem also is an epidemic of sexually transmitted genital warts. The CDC says HPV causes more than 6 million new cases of genital warts in this country every year.
There are many cases in medical history where vaccination has proved extremely effective in promoting public health even in the face of possible side effects."
http://www.newsday.com/news/printedition/opinion/ny-opsie205101066feb20,0,3529854.story?coll=ny-opinion-print
The coverage of a recent data dredging effort looking at the RELATIVE RISKS of taking different painkillers and high blood pressures for the most part failed to make the qualifications the researchers did. (This was a study of heavy, obese males in the main who were frequent users of all sorts of pain killers against non users that did not control for any other medications) The increase in risk of 33 percent was an increase in risk from 1 percent to 1.36 percent. Leave to scaremonger at the Washington Post
Shankar Vedantam to write a story with the headline : Doctors Warned About Common Drugs for Pain NSAIDs Tied to Risk of Heart Attack, Stroke... Aargh..
But Seniorjournal.com saves the day with straightforward reporting that just gives the facts without the unscientific spin that shady Shankar always seems to give to his stories:
Older Men Regularly Taking Over-the-Counter Pain Relievers have Risk of High Blood Pressure
http://www.seniorjournal.com/NEWS/Health/2007/7-02-26-OlderMenRegularly.htm
Greek physicians of the Hippocratic period would not treat patients they didn’t think they could “cure.†They believed it was bad for the patient (“First, do no harmâ€) as well as bad for their reputation. This latter point may seem shocking today, but it was not exceptional in ancient medicine – in fact, it was an integral part of the prognosis process.
When such a situation arose, the ancient Greek physician resigned himself to what was called “noble flight.†(An early example, it should be noted, of health care “spin.â€)
But such a thing could never happen today, right?
Well, hopefully – but the current debate over pay-for-performance is re-opening the debate, among many physicians, about the wisdom of accepting difficult to treat patients. What’s old is new again. Consider M&M conferences. While never pleasant, they do serve an important purpose. Now imagine if physicians avoided cases they couldn’t “cure.†Is ignorance really bliss? Can we allow remuneration to trump patient care?
And that's precisely what will happen unless we can more precisely define metrics for pay-for-performance programs that take into consideration multiple variables -- the most important being the individual patient. Otherwise we fall into the morass of so-called evidence-based (read "cost-based') medicine rather than patient-centric care. Saving money by providing anything other than optimum treatment (pharmaceutical and otherwise) is not only penny-wise and pound foolish from an outcomes perspective -- it's also just plain ethically wrong.
Health care isn't a yes/no proposition. The ancient Greeks thought in terms of "cure." Today we think in terms of "treatment." And "treatment certainly isn't binary.
After all, is the ancient Greek fear of damage to one’s reputation really any different than today's fear of reduced payment? We've come too far to stumble on such petty grounds.
When such a situation arose, the ancient Greek physician resigned himself to what was called “noble flight.†(An early example, it should be noted, of health care “spin.â€)
But such a thing could never happen today, right?
Well, hopefully – but the current debate over pay-for-performance is re-opening the debate, among many physicians, about the wisdom of accepting difficult to treat patients. What’s old is new again. Consider M&M conferences. While never pleasant, they do serve an important purpose. Now imagine if physicians avoided cases they couldn’t “cure.†Is ignorance really bliss? Can we allow remuneration to trump patient care?
And that's precisely what will happen unless we can more precisely define metrics for pay-for-performance programs that take into consideration multiple variables -- the most important being the individual patient. Otherwise we fall into the morass of so-called evidence-based (read "cost-based') medicine rather than patient-centric care. Saving money by providing anything other than optimum treatment (pharmaceutical and otherwise) is not only penny-wise and pound foolish from an outcomes perspective -- it's also just plain ethically wrong.
Health care isn't a yes/no proposition. The ancient Greeks thought in terms of "cure." Today we think in terms of "treatment." And "treatment certainly isn't binary.
After all, is the ancient Greek fear of damage to one’s reputation really any different than today's fear of reduced payment? We've come too far to stumble on such petty grounds.
The British have always been fond of the Irish Sweepstakes. Unfortunately (and once again) NICE and the NHS are asking patients with kidney disease to play the Renal Disease Sweepstakes.
Should health care really be a crap shoot with terrible odds?
Kidney cancer victims denied "wonder drugs"
The Sunday Times (London) By Daniel Foggo and Sarah-Kate Templeton;
25 February 2007
Two new "wonder drugs" with the potential to prolong the lives of thousands of kidney cancer sufferers are being denied to National Health Service patients because they are too expensive.
The drugs, Sutent and Nexavar, have been shown to shrink tumours dramatically, with some disappearing altogether. Both have been licensed for use in Britain but the NHS has so far declined to issue guidance that trusts should fund the drugs.
Without such guidelines, patients are dependent on the judgment of individual NHS trusts deciding whether or not they can afford the treatment, which costs about £2,500 a month. Some cancer sufferers have been forced to sell their houses or cash in pension schemes to pay for the treatment.
The situation has been likened by doctors to the furore over Herceptin. The breast cancer drug was not routinely prescribed until August last year, following intervention by Patricia Hewitt, the health secretary.
Nicholas James, consultant in clinical oncology at Queen Elizabeth hospital, Birmingham, said of Nexavar: "Patients with this cancer tend to die quite quickly but I know from my own patients who were on the trial how well this drug works. They are still alive two years later."
Despite the enthusiasm of doctors, the National Institute for Health and Clinical Excellence, which draws up the NHS's policies on whether trusts should fund medicines, has so far set no timetable for assessing the two kidney cancer drugs.
As a result, patients can obtain the drugs only through a private doctor or by asking their GP to plead their case individually to primary care trusts (PCTs).
Kidney cancer, which is diagnosed in about 6,600 people each year, has a death rate of more than 50% and is difficult to treat, with both radiotherapy and chemotherapy of little use.
Until the development of Sutent and Nexavar, which both work on the principle of starving tumours of their blood supply, the only viable treatment was the drug interferon alpha.
But in trials of Sutent it was shown to more than double the time tumours remained static in size compared with interferon. Nexavar had similar results.
Professor Robert Hawkins, an oncologist at Christie hospital in Manchester, who conducted a recent Sutent trial, said: "We have had a couple of patients where the cancer seems to have disappeared altogether." At least one patient -- who served in the RAF -- is seeking judicial review over the drug. It was similar action over Herceptin that contributed to its approval as an NHS drug.
Janine Handrick, 35, a travel adviser and mother of five-year-old Madison, is one patient who, with her GP, managed to persuade her PCT in Doncaster, South Yorkshire, to put her on Sutent in December.
"I was diagnosed with cancer last March when they found lumps on my right kidney and in my coccyx," she said. "They removed the kidney but it had spread to my bones and lungs. When the nurse told me they had found tumours, I asked if I would die and she just nodded.
"When my doctor told me they had decided to give Sutent to me, I was ecstatic, although I won't know how effective it is until I have a scan in another six weeks."
Mark Franklin, 39, a builder from Buckinghamshire, was also facing death when he was included in a trial of Sutent last June. The cancer had spread from one kidney, which was removed, to his ribs, lungs, back and other kidney. Now his tumours have shrunk dramatically and this May he plans to climb Britain's three highest mountains.
"There is no doubt I would be dead now if it wasn't for the trial," said Franklin. "Not making this drug available to everyone on the NHS is criminal."
He is one of almost 1,000 signatories so far to an e-petition on the 10 Downing Street website calling on the prime minister to make Sutent and Nexavar freely available.
A spokesman for Kidney Cancer UK said: "These drugs are available in much of Europe and the US but here it is a postcode lottery. We are taking legal advice on whether PCTs can refuse to prescribe these drugs because of cost."
The real saving, in mortality, misery and expense, would come from earlier detection. My cancer, slow-growing and occupying about one-fifth of my left kidney, was detected by ultrasound, which was administered for another reason. This was some ten years before I should have noticed any symptoms, and before the growth could spread to other organs. Partial nephrectomy, with biopsy of a surrounding margin in the operating theatre, was sufficient. I now have one and three-quarters healthy kidneys. Radical nephrectomy will be needed only if my annual ultrasound shows that cancer has recurred in that kidney, and partial nephrectomy is still in reserve for the other side if cancer should be detected there.
Should health care really be a crap shoot with terrible odds?
Kidney cancer victims denied "wonder drugs"
The Sunday Times (London) By Daniel Foggo and Sarah-Kate Templeton;
25 February 2007
Two new "wonder drugs" with the potential to prolong the lives of thousands of kidney cancer sufferers are being denied to National Health Service patients because they are too expensive.
The drugs, Sutent and Nexavar, have been shown to shrink tumours dramatically, with some disappearing altogether. Both have been licensed for use in Britain but the NHS has so far declined to issue guidance that trusts should fund the drugs.
Without such guidelines, patients are dependent on the judgment of individual NHS trusts deciding whether or not they can afford the treatment, which costs about £2,500 a month. Some cancer sufferers have been forced to sell their houses or cash in pension schemes to pay for the treatment.
The situation has been likened by doctors to the furore over Herceptin. The breast cancer drug was not routinely prescribed until August last year, following intervention by Patricia Hewitt, the health secretary.
Nicholas James, consultant in clinical oncology at Queen Elizabeth hospital, Birmingham, said of Nexavar: "Patients with this cancer tend to die quite quickly but I know from my own patients who were on the trial how well this drug works. They are still alive two years later."
Despite the enthusiasm of doctors, the National Institute for Health and Clinical Excellence, which draws up the NHS's policies on whether trusts should fund medicines, has so far set no timetable for assessing the two kidney cancer drugs.
As a result, patients can obtain the drugs only through a private doctor or by asking their GP to plead their case individually to primary care trusts (PCTs).
Kidney cancer, which is diagnosed in about 6,600 people each year, has a death rate of more than 50% and is difficult to treat, with both radiotherapy and chemotherapy of little use.
Until the development of Sutent and Nexavar, which both work on the principle of starving tumours of their blood supply, the only viable treatment was the drug interferon alpha.
But in trials of Sutent it was shown to more than double the time tumours remained static in size compared with interferon. Nexavar had similar results.
Professor Robert Hawkins, an oncologist at Christie hospital in Manchester, who conducted a recent Sutent trial, said: "We have had a couple of patients where the cancer seems to have disappeared altogether." At least one patient -- who served in the RAF -- is seeking judicial review over the drug. It was similar action over Herceptin that contributed to its approval as an NHS drug.
Janine Handrick, 35, a travel adviser and mother of five-year-old Madison, is one patient who, with her GP, managed to persuade her PCT in Doncaster, South Yorkshire, to put her on Sutent in December.
"I was diagnosed with cancer last March when they found lumps on my right kidney and in my coccyx," she said. "They removed the kidney but it had spread to my bones and lungs. When the nurse told me they had found tumours, I asked if I would die and she just nodded.
"When my doctor told me they had decided to give Sutent to me, I was ecstatic, although I won't know how effective it is until I have a scan in another six weeks."
Mark Franklin, 39, a builder from Buckinghamshire, was also facing death when he was included in a trial of Sutent last June. The cancer had spread from one kidney, which was removed, to his ribs, lungs, back and other kidney. Now his tumours have shrunk dramatically and this May he plans to climb Britain's three highest mountains.
"There is no doubt I would be dead now if it wasn't for the trial," said Franklin. "Not making this drug available to everyone on the NHS is criminal."
He is one of almost 1,000 signatories so far to an e-petition on the 10 Downing Street website calling on the prime minister to make Sutent and Nexavar freely available.
A spokesman for Kidney Cancer UK said: "These drugs are available in much of Europe and the US but here it is a postcode lottery. We are taking legal advice on whether PCTs can refuse to prescribe these drugs because of cost."
The real saving, in mortality, misery and expense, would come from earlier detection. My cancer, slow-growing and occupying about one-fifth of my left kidney, was detected by ultrasound, which was administered for another reason. This was some ten years before I should have noticed any symptoms, and before the growth could spread to other organs. Partial nephrectomy, with biopsy of a surrounding margin in the operating theatre, was sufficient. I now have one and three-quarters healthy kidneys. Radical nephrectomy will be needed only if my annual ultrasound shows that cancer has recurred in that kidney, and partial nephrectomy is still in reserve for the other side if cancer should be detected there.
When we disagree with the New York Times editorial page, we say so. Today we strongly agree with their position on mandatory HPV vaccinations. Here's what the Gray Lady has to say ...
A Necessary Vaccine
Debate over a new vaccine to prevent cervical cancer and genital warts has reached a high pitch. State legislatures are debating whether to mandate the vaccine or insist that its use be kept voluntary. The manufacturer stopped a vigorous lobbying campaign lest it provoke more opposition than support. And some health professionals who had been championing the vaccine flinched at making it mandatory, at least for now.
Even so, state legislatures should require that all young girls be given this vaccine, which protects against a virus that causes some 10,000 new cases of cervical cancer in the United States each year — and 3,700 cancer deaths.
Three weeks ago we applauded Gov. Rick Perry for making Texas the first state to require vaccinating young schoolgirls — ages 11 and 12 — against the human papillomavirus. In the ensuing uproar, the Texas House has moved to overturn his order, but the Virginia Legislature has approved a similar mandate. Some 20 states have bills pending to require the vaccinations for school attendance.
We have endorsed a mandate because the vaccine — Merck’s Gardasil — looks highly effective against strains that cause 70 percent of all cervical cancer. With more than two million doses already distributed, the reported side effects have been mostly minor, such as dizziness or fainting. Many parents who oppose a mandate are aghast at the thought of vaccinating such young girls against a sexually transmitted disease. But the vaccine works only if taken before a girl becomes infected. Social conservatives object that the vaccine will encourage promiscuity, but it seems farfetched to believe that protection from cervical cancer will change any girl’s behavior. Others complain that a mandate will pre-empt parental rights to make health decisions, but all vaccine mandates do that, to protect the children and those they might infect.
The strongest arguments against moving ahead quickly tend to be practical and financial. States have typically used school mandates for vaccines that are already in wide use, and it is possible that unexpected side effects could emerge (though any mandate could be suspended if that happened). Health professionals also need to be certain that there are stable supplies, adequate insurance coverage, ample public money to vaccinate low-income children and physician support.
Merck deserves praise for developing Gardasil at a time when many companies shun the vaccine business as risky and unprofitable. But it is charging $360 for a three-dose regimen, a price that might come down if a competing vaccine enters the market soon, as expected.
The vaccine could prevent thousands of new cases of cervical cancer annually and hundreds of thousands of cases of genital warts and precancerous growths. A mandate would force the health care system to get cracking. And it is the best way to ensure that all children get the vaccine, not just those who are aware of it and can afford it.
A Necessary Vaccine
Debate over a new vaccine to prevent cervical cancer and genital warts has reached a high pitch. State legislatures are debating whether to mandate the vaccine or insist that its use be kept voluntary. The manufacturer stopped a vigorous lobbying campaign lest it provoke more opposition than support. And some health professionals who had been championing the vaccine flinched at making it mandatory, at least for now.
Even so, state legislatures should require that all young girls be given this vaccine, which protects against a virus that causes some 10,000 new cases of cervical cancer in the United States each year — and 3,700 cancer deaths.
Three weeks ago we applauded Gov. Rick Perry for making Texas the first state to require vaccinating young schoolgirls — ages 11 and 12 — against the human papillomavirus. In the ensuing uproar, the Texas House has moved to overturn his order, but the Virginia Legislature has approved a similar mandate. Some 20 states have bills pending to require the vaccinations for school attendance.
We have endorsed a mandate because the vaccine — Merck’s Gardasil — looks highly effective against strains that cause 70 percent of all cervical cancer. With more than two million doses already distributed, the reported side effects have been mostly minor, such as dizziness or fainting. Many parents who oppose a mandate are aghast at the thought of vaccinating such young girls against a sexually transmitted disease. But the vaccine works only if taken before a girl becomes infected. Social conservatives object that the vaccine will encourage promiscuity, but it seems farfetched to believe that protection from cervical cancer will change any girl’s behavior. Others complain that a mandate will pre-empt parental rights to make health decisions, but all vaccine mandates do that, to protect the children and those they might infect.
The strongest arguments against moving ahead quickly tend to be practical and financial. States have typically used school mandates for vaccines that are already in wide use, and it is possible that unexpected side effects could emerge (though any mandate could be suspended if that happened). Health professionals also need to be certain that there are stable supplies, adequate insurance coverage, ample public money to vaccinate low-income children and physician support.
Merck deserves praise for developing Gardasil at a time when many companies shun the vaccine business as risky and unprofitable. But it is charging $360 for a three-dose regimen, a price that might come down if a competing vaccine enters the market soon, as expected.
The vaccine could prevent thousands of new cases of cervical cancer annually and hundreds of thousands of cases of genital warts and precancerous growths. A mandate would force the health care system to get cracking. And it is the best way to ensure that all children get the vaccine, not just those who are aware of it and can afford it.
According to Dr. Valerio Reggi, chief of the anticounterfeiting task force created last year by the WHO (and as reported in the New York Times), in many countries, "counterfeiting a T-shirt means 10 years in jail, but counterfeiting a medicine can be a misdemeanor."
A deadly misdemeanor.
A deadly misdemeanor.
In the wake of the scandal surrounding third world outpatient care for our troops at Walter Reed comes this riposte from prize winning war correspondent Joe Galloway:
Chris Adams's Feb. 9 report that even by its own measures, the Veterans Administration isn't prepared to give returning veterans the care they need to help them overcome destructive, and sometimes fatal, mental health ailments. Nearly 100 VA clinics provided virtually no mental health care in 2005, Adams found, and the average veteran with psychiatric troubles gets about a third fewer visits with specialists today than he would have received a decade ago.
Here's the Chris Adams piece about the VA system pols want to expand to provide drug benefits for us all.
http://seattletimes.nwsource.com/cgi-bin/PrintStory.pl?document_id=2003566773&zsection_id=2002107549&slug=vets11&date=20070211
I want Ron Pollack to be the first one to enroll himself and his family
Mrs Clinton and her followers should be next...
Contrast this with Hillary's bubbly view of the VA -- her shining model for national health care since her last iteration, regional health gulags, crashed and burned...."The VA is leading the way in reducing medical errors, improving patient safety, and delivering high quality care; now this is a lesson about what can be done when we have a plan. A plan that is evidence-based, a plan that uses what we know works, and a system that we can actually get to respond to that evidence-based planning. The other thing the VA has done to keep costs down is negotiate for drug prices with the drug companies."
Chris Adams's Feb. 9 report that even by its own measures, the Veterans Administration isn't prepared to give returning veterans the care they need to help them overcome destructive, and sometimes fatal, mental health ailments. Nearly 100 VA clinics provided virtually no mental health care in 2005, Adams found, and the average veteran with psychiatric troubles gets about a third fewer visits with specialists today than he would have received a decade ago.
Here's the Chris Adams piece about the VA system pols want to expand to provide drug benefits for us all.
http://seattletimes.nwsource.com/cgi-bin/PrintStory.pl?document_id=2003566773&zsection_id=2002107549&slug=vets11&date=20070211
I want Ron Pollack to be the first one to enroll himself and his family
Mrs Clinton and her followers should be next...
Contrast this with Hillary's bubbly view of the VA -- her shining model for national health care since her last iteration, regional health gulags, crashed and burned...."The VA is leading the way in reducing medical errors, improving patient safety, and delivering high quality care; now this is a lesson about what can be done when we have a plan. A plan that is evidence-based, a plan that uses what we know works, and a system that we can actually get to respond to that evidence-based planning. The other thing the VA has done to keep costs down is negotiate for drug prices with the drug companies."
Marilyn Chase had an good piece in the WSJ about how doctors and consumers have driven the debate over whether to use Avastin off label to treat macular degeneration for about $40 a dose or the drug Genentech developed for the disease and for which it received FDA approval. Lucentis is administered in the form of smaller molecules, which is thought to give Lucentis an advantage over Avastin in its ability to penetrate the eye's retina and halt abnormal blood vessel growth contributing to advanced macular degeneration and scarring that causes blindness. But opthamologists think otherwise. They began using Avastin as a placeholder while Lucentis was being developed and have stuck with it because it is cheaper and see no reason to change. Now the NIH is seeking to conduct a head to head trial which, if it goes the way of all large scale trials,will show no difference except in terms of side effects which is a huge exception since it relates directly to individual response to doses. And that is something that Judah Folkman observed in the Phase I trials of Avastin way back when but back then the FDA insisted everyone had to get the same dose.
So the head to head trial is really a product of one size fits all science, not Genentech's evil effort to milk profit out of Avastin, For perspective, note that in it's recent study to determine the effectiveness of Avastin in lung cancer, Genentech found that a smaller dose was as effective as a higher dose. It would behoove Genenetch and those who are setting up the Lucentis trial as a sentinel event for government run comparative effectiveness research to look at which patients do best at which dose and molecule size. That's where medicine is heading. And if we want to avoid across the board reimbursement decisions that drive one size fits all medicine, Genentech and other companies are going to have to get ahead of the curve as it did with Avastin in lung cancer. It must change the conversation with consumers and doctors by giving them different and better information.
As it can see (no pun intended), the media will not do it for them....
Genentech's Big Drug For Eyes Faces a Rival
So the head to head trial is really a product of one size fits all science, not Genentech's evil effort to milk profit out of Avastin, For perspective, note that in it's recent study to determine the effectiveness of Avastin in lung cancer, Genentech found that a smaller dose was as effective as a higher dose. It would behoove Genenetch and those who are setting up the Lucentis trial as a sentinel event for government run comparative effectiveness research to look at which patients do best at which dose and molecule size. That's where medicine is heading. And if we want to avoid across the board reimbursement decisions that drive one size fits all medicine, Genentech and other companies are going to have to get ahead of the curve as it did with Avastin in lung cancer. It must change the conversation with consumers and doctors by giving them different and better information.
As it can see (no pun intended), the media will not do it for them....
Genentech's Big Drug For Eyes Faces a Rival
At first glance, Japan's health-care system seems superior to America's. Its infant mortality rate is among the world's lowest. Japan's life expectancy is the world's highest for women (85.6 years) and the fourth-highest for men (80.4 years).
All this has been achieved at a fraction of what the United States spends. Only 9 percent of Japan's gross domestic product is spent on health care, while America spends almost twice that. It seems like the perfect system. For many, perhaps it is -- unless you actually need to use it ... and particularly if you have cancer.
Have a look at this new op-ed that appears in the Commentary section of today's edition of The Washington Times:
http://www.washingtontimes.com/commentary/20070222-084946-2121r.htm
A health-care system's success shouldn't simply be based on life expectancy and fiscal policy but rather on individual outcomes.
Candidates in the 2008 presidential race have already begun vying for Americans' votes. Improving the nation's health-care system has already surfaced as a major issue for all those seeking the job. But it's hardly an improvement on our health-care system if politicians seek to turn our life-and-death health-care decisions over to bureaucrats and budget-crunchers.
Japan's cancer refugees have just issued a wake-up call to their own government. It would be a shame if we didn't heed their warning and ended up with cancer refugees of our own.
All this has been achieved at a fraction of what the United States spends. Only 9 percent of Japan's gross domestic product is spent on health care, while America spends almost twice that. It seems like the perfect system. For many, perhaps it is -- unless you actually need to use it ... and particularly if you have cancer.
Have a look at this new op-ed that appears in the Commentary section of today's edition of The Washington Times:
http://www.washingtontimes.com/commentary/20070222-084946-2121r.htm
A health-care system's success shouldn't simply be based on life expectancy and fiscal policy but rather on individual outcomes.
Candidates in the 2008 presidential race have already begun vying for Americans' votes. Improving the nation's health-care system has already surfaced as a major issue for all those seeking the job. But it's hardly an improvement on our health-care system if politicians seek to turn our life-and-death health-care decisions over to bureaucrats and budget-crunchers.
Japan's cancer refugees have just issued a wake-up call to their own government. It would be a shame if we didn't heed their warning and ended up with cancer refugees of our own.
Recently I spoke at a joint California Healthcare Institute/Pacific Research Institute conference on evidence-based medicine -- with a particular focus on how it isn't working all that well Down Under, and a few important lessons we should learn from the Aussie experience.
Here's a video podcast of my remarks:
http://sys-con.com/read/340224.htm
Enjoy.
Here's a video podcast of my remarks:
http://sys-con.com/read/340224.htm
Enjoy.
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.
