Amgen Lobbying In DC Paying Off? Maybe
10 CommentsBy Ed Silverman // September 5th, 2007 // 11:49 am
The biotech’s investors were quite pleased this morning after the US Senate passed a resolution requesting the Centers for Medicare and Medicaid Services reconsider its decision to place tougher reimbursement restrictions on anemia drugs used by chemo patients - Amgen’s Epogen and Aranesp, as well as Johnson & Johnson’s Procrit, the Associated Press reports.
Medicare proposed the new guidelines after the FDA added warnings to the drug labels in March over concerns that usage at high levels - more than 10 grams per deciliter - can increase risk of blood clots, heart attack and death. An FDA panel in May also called for restrictions. Cancer docs, however, have argued that higher levels are necessary to stabilize many patients and the current FDA labeling cites a higher level of 12 grams.
Last week, in fact, the American Society of Clinical Oncology was in the midst of lobbying to loosen Medicare restrictions, arguing the tight payment guidelines for treatments are bad for patients. Although the new rules are also bad for cancer docs, because they can only be reimbursed if they use low levels of the drugs.
Not so coincidentally, the Senate resolution emerges after Amgen roughly doubled the amount spent on lobbying in on lobbying in Washington, DC, as the biotech tried to recover from a crisis that’s causing layoffs. Just last week, Eric Schmidt, a Cowen biotech analyst, met with Amgen execs and wrote in an investor note the biotech “is cautiously optimistic that its efforts and those being taken on behalf of physician and patient groups will eventually persuade CMS to reverse course.”
Just the same, Wall Street remains skittish about the extent to which Medicare officials will change their minds. In an investor note today, Jim Reddoch of Friedman Billings Ramsey calls the Senate resolution ‘window dressing,’ because it’s non-binding and echoes the sentiment of some senators who were already opposed to the Medicare change. He adds that, so far, there’s no companion piece in the House and, therefore, the Medicare guidelines are unlikely to be reversed.
Meanwhile, two FDA advisory committees - Cardiovascular and Renal Drugs and Drug Safety and Risk Management - will hold a joint meeting on Sept. 11 to review the risks and benefits of the EPO drugs for use in patients with chronic renal failure.
DAVID
NICE TO SEE MR PHARMALOT IS BACK WORKING AGAIN
Gregory D. Pawelski
EPO is a natural substance made by the kidney. It stimulates the bone marrow to make red blood cells (it is literally a “growth factor”). Healthy adults are usually at about 15 grams a deciliter. When normal people take it, their blood gets too “thick” and they die of heart attacks and strokes.
But it now looks as if increasing the hemoglobin level above 12 is very risky with pharmaceutical EPO. Pharmaceutical EPO makes sludgy blood.
The anemia drugs, which boosts patients’ counts of hemoglobin (a protein that carries oxygen in the blood), raise the danger of heart attacks, strokes and death at “high” doses. The FDA has said there is “serious” cardiovascular risks for patients who took “higher than recommended” doses of these drugs. Also, patients who don’t respond well to initial anemia therapy (hyporesponders) are exposed to the highest heart risks.
These anemia drugs are approved to treat patients whose weakness and fatigue is caused by chronic kidney disease or by the side effects of cancer chemotherapy. They stimulate production of oxygen-carrying red blood cells, which can boost patients’ energy and strength. The issue is over the drugs’ safety on how big a dose to use to boost concentrations of hemoglobin. The FDA-approved level is doses sufficient to increase hemoglobin to a maximum of 12 grams a deciliter.
Blood transfusions are generally needed when patients slip to less than 8 grams. The adage of some physicians was that if some improvement in hemoglobin was good, higher levels of hemoglobin would even be better. However, clinical trials have shown the drugs can reduce the need for blood transfusions and improve the quality of life when used within the “original” dosing range.
New studies have raised questions whether these drugs might be harming patients. Those study results suggest the drugs may make the cancer worse. One such study published in the New England Journal of Medicine found that patients treated aggressively with Procrit had a higher risk of heart problems or death than those treated less aggressively.
As reported in OncoLink, patients and clinicians must understand that no data exists to support claims of improvement in quality of life or fatigue. The manufacturers of these agents frequently used direct consumer marketing to promote these unsupported claims, a fact that concerns many patient advocacy groups.
And now there is emerging evidence that pharmaceutical EPO can feed the growth of tumors in cancer patients (it IS a “growth factor” afterall).
The problem is that few drugs work the way oncologists think and few of them take the time to think through what it is they are using them for. Take medical oncologists out of the retail pharmacy business and force them to be cancer “doctors” again!
hchcec
“The problem is that few drugs work the way oncologists think and few of them take the time to think through what it is they are using them for.”
Ridiculous comment from a nonscientist, an individual known as the internet’s most infamous cancer therapy fearmonger.
——
New research has not shown an EPO-cancer growth relationship.
“This reasonably large randomized trial does not show an adverse effect of Aranesp on progression-free survival of patients with extensive stage SCLC receiving chemotherapy. These data would suggest that Aranesp did not stimulate cancer growth in this setting. However, this study did confirm the increased incidence of thromboembolic events, which did not affect survival.”
http://professional.cancerconsultants.com/oncology_main_news.aspx?id=40520
Gregory D. Pawelski
The little internet blog groupie Michelle (hchcec) has given us a campaign, supported and funded by Amgen.
The ProtectCancerPatients.org website is a campaign supported and funded by Amgen - one of the manufacturers of pharmaceutical EPO.
The Michelle (hchcec) character has been posting on the internet that an Anemia drug study shows no link to tumor growth. However, the study does not say anything about anemia drugs not showing a link.
The study “suggests” that extended doses of Amgen’s anemia drug Aranesp, when paired with chemotherapy treatment, work as well as weekly doses (this does not say anything that anemia drugs are not a growth factor).
The data from the study showed that results from two combined studies indicate patients treated with the drug needed fewer blood transfusions without serious impacts (this does not say anything that anemia drugs are not a growth factor).
The company said, “These analyses do not suggest a negative impact on overall survival or progression-free survival between patients receiving chemotherapy treatment with aranesp and those that did not receive Aranesp.” (this does not say anything that anemia drugs are not a growth factor)
And who is the “sponsor” of this study, and six other trials of Aranesp to treat anemia as a result of chemotherapy??? Amgen!!! Of course!!!
hchcec
OOPS! Pawelski misinterprets and misinforms again. Nothing new for the internet’s most prolific cancer fearmonger. He won’t be happy until you are as unhappy as he is . He has a grudge, you know.
The study conclusion:
This reasonably large randomized trial does NOT show an adverse effect of Aranesp on progression-free survival of patients with extensive stage SCLC receiving chemotherapy. These data would suggest that Aranesp did NOT stimulate cancer growth in this setting.
Here’s another for ya, G.P.
http://mct.aacrjournals.org/cgi/content/full/5/2/347
Let’s see if you can spin this one so as to cause fear in cancer patients. (Methinks Pawelski wants you to try homeopathy for your cancer :wink: )
Pawelski’s logical fallacy of the day:
The Michelle (hchcec) character has been posting on the internet that an anemia drug study shows no link to tumor growth. However, the study does not say anything about anemia drugs not showing a link.
That’s like me saying there’s no evidence for Bigfoot. Then Pawelski then states: “there’s no evidence Bigfoot doesn’t exist.” Sorry Mr. Fearmonger. It’s up to you to prove Bigfoot (anemia drug tumor growth link) exists, no for me to prove it doesn’t.
So illogical. But, remember, G.P preys on your emotions. Logic is left in the dust.
hchcec
Jack
“The manufacturers of these agents frequently used direct consumer marketing to promote these unsupported claims, a fact that concerns many patient advocacy groups.”
Any evidence of this?
Gregory D. Pawelski
Medicare said its decision was based on exhaustive review of more than 800 individual publications and approximately 2,600 comment letters received during two public comment periods. The agency reconsiders an NCD only when new evidence or arguments are presented that the agency materially misinterpreted existing evidence. CMS said that ASCO presented no new evidence to the contrary.
Congress has been intensifying its scrutiny of Medicare spending on pharmaceutical EPO, which represents the single largest drug expense for the program. Some key lawmakers view the manufacturers of EPO skeptically, citing Medicare’s rising spending on the drugs. Earlier in the year, U.S. Oncology reported in their first quarter SEC Form 10-K report that cancer patients are suddenly using a lot less anemia drugs and as a result U.S. Oncology will bank $8-10 million a year less than expected. Several groups ask Congress not to intervene in the CMS decision on anemia drugs.
I’ve been told that publishing anything in any forum, there would be some nut case who is incapable of addressing the topic at hand and instead launch into a personal attack, usually by ascribing to me some neurosis that actually applies to them. Obviously, there are a lot of seriously disturbed people in the world.
There was a French guy named Michelle at a Medical Systems company who was fired and thereafter stalked the financial message boards with moronic comments such as what one would expect from a disaffected employee. Michell’s tortured syntax is reminiscent of the French Michelle’s idiotic writing style. I wonder?
Remember, Michelle (hchcec) is hiding behind a moniker to disguise the reasons for her misinformation. Hiding behind one does not lend her any credibility. Her own comments always bite of conspiracy theories, a diversion to counter ideas other than hers.
hchcec
Notice prolific internet support group troll Pawelski stated this:
there is emerging evidence that pharmaceutical EPO can feed the growth of tumors in cancer patients (it IS a “growth factor†afterall).”
I addressed this in my comments to Pawelski and indicated that this is not so.
How does he respond?
“there would be some nut case who is incapable of addressing the topic at hand and instead launch into a personal attack”
However, I have addressed the topic at hand. Pawelski’s defensiveness is quite evident in his emotional response. He will continue to refuse to address the fact that there is no link between EPO and tumor growth. But, if you do a google search on this topic with his name, he will post this wholly inaccurate information so cancer patients can read it on their support sites. This causes fear in the cancer patient which is Pawelski’s goal.
Why is this his goal:
“There’s this multi-billion dollar cottage industry called chemo-radiation therapy just waiting for an excuse to fulfill your cancer treatment needs.”
“I’ve spent two years with many a sleepless night researching what really happened to my wife and how she was killed. Yes, I’m bitter and angered.”
This is not rational thinking as you know.
http://www.cancerstory.com/servlets/story_ann.jsp
Gregory D. Pawelski
Seek help Michelle (hchcec), seek help, before the looney bin comes for you!
hchcec
Nice counterargument, Pawelski.
“I’m bitter and angered.”
——————Gregory Pawelski