The Danger in Drug Kickbacks (Epogen, Procrit)

[okarol]

The Danger in Drug Kickbacks

Published: May 14, 2007
New York Times - Editorial

The explosion in the use of three anti-anemia drugs to treat cancer and kidney patients illustrates much that is wrong in the American pharmaceutical marketplace. Thanks to big payoffs to doctors, and reckless promotional ads permitted by lax regulators, the drugs have reached blockbuster status. Now we learn that the dosage levels routinely injected or given intravenously in doctors’ offices and dialysis centers may be harmful to patients.

As Alex Berenson and Andrew Pollack laid bare in The Times on May 9, wide use of the medicines — Aranesp and Epogen, from Amgen; and Procrit, from Johnson & Johnson — has been propelled by the two companies paying out hundreds of millions of dollars in so-called rebates. Doctors typically buy the drugs from the companies, get reimbursed for much of the cost by Medicare and private insurers, and on top of that get these rebates based on the amount they have purchased.

Although many doctors complain that they barely break even or even lose money on the costly drugs, for high-volume providers the profits can be substantial. One group of six cancer doctors in the Pacific Northwest earned a profit of about $1.8 million last year thanks to rebates from Amgen, while a large chain of dialysis centers gets an estimated 25 percent of its revenue, and a higher percentage of its profits, from the anemia drugs. It seems likely that these financial incentives have led to wider use and the prescribing of higher doses than medically desirable.

Although the drugs are deemed valuable in fighting severe anemia, there is scant evidence they help much in moderate cases and some evidence that high doses can be dangerous. Half of the dialysis patients in this country are now receiving enough of the drugs to raise their red blood cell counts to levels deemed risky by the Food and Drug Administration. And last week a panel of cancer experts urged the F.D.A. to impose additional restrictions on use of the drugs in patients receiving cancer chemotherapy, based on studies that the drugs might make some cancers worse or hasten the deaths of patients.

Use of Procrit has also been fueled by television ads suggesting that it makes elderly cancer patients more energetic and, pushing all the emotional buttons, allows them to keep up with their grandchildren. That claim has not been established to the F.D.A.’s satisfaction, and a top official said last week that his agency owes the public a good explanation for why it allowed the ads to continue.

With any luck, the advisory panel’s concerns should cause many oncologists to think twice before dispensing the anti-anemia drugs. But the surest way to slow the overprescribing is to stop the rebates. Federal laws already bar drug companies from paying doctors to prescribe medicines in pill form. That prohibition should be extended to injected and intravenous medicines.

http://www.nytimes.com/2007/05/14/opinion/14mon1.html

[Black]

Since the dosage of these drugs for dialysis patients is set by Medicare I doubt most of those here have to be concerned.  BUT, I would not be surprised to learn that there are a few here that are having their insurance company soaked for extra charges for a higher dosage than they actually need.

[okarol]

We were discussing anemia at Jenna's follow-up appointment last week The surgeon said that they are learning that Procrit and Epogen can cause an over abundance in red cell production in some people, leading to possible blood clots, strokes and heart attacks. They are being very cautious about administering these now.

[Black]

3.99

We were discussing anemia at Jenna's follow-up appointment last week The surgeon said that they are learning that Procrit and Epogen can cause an over abundance in red cell production in some people, leading to possible blood clots, strokes and heart attacks. They are being very cautious about administering these now.

Yes, I had heard that it has been determined to be a danger for some patients and I was concerned because Mike got his first Epo shot (and an iron infusion) last Thursday.

He'll be getting .25 ml of Epo every Thursday until his labs next month.  I was VERY surprised when he got home and told me about it.  PKD kidneys usually work well enough to avoid anemia for a very long time after they quit filtering urine.  He definately did not have a problem with anemia until after he started dialysis in Feb.  Now his hemoglobin (11.9) and hemocrit (37.1) are barely within normal range and his RBC (3.99) is .01 below the normal range.

He said they told him at the clinic that he would be feeing better and have more energy and he said he can't imagine feeling any better than he does now    (thank God for NxStage!)  After more than a year of being so toxic at 10% kidney function, he is amazed by how much better he already feels.

He's looking forward to feeling even better, but I will be watching carefully to see that his levels do not go too high.

[Rerun]

They throw away tons of red blood cells.  They don't clear the lines at the end of treatment.  I know we don't want to add extra fluid, but they don't have to be bright PINK.  I think it is so they can use more Epogen. 

20 years ago when we didn't have Epogen those lines were clear.  The only treatment for anemia was a blood transfusion. 

Now they don't care.....just fill her up with Epo.

[charee]

 Hey Black  I started Epo shots every fortnight 6 months before i started dialysis and had one iron infusion, now that I'm dialysis i still have the epo and for the first 5 weeks i will have iron via the machine. oh yeah i have PKD and still pee abit.

[Wattle]

 Hey Black  I started Epo shots every fortnight 6 months before i started dialysis and had one iron infusion, now that I'm dialysis i still have the epo and for the first 5 weeks i will have iron via the machine. oh yeah i have PKD and still pee abit.

Like Charee i am also PKD and was started on Arenesp about one year before starting dialysis. Anemia is common with PKD patients.

[Black]

Mike's PKD kidneys still produce a lot of clear urine, but were at only 9% function when he started dialysis in Feb.  More often than not, he has to go while hooked up to the NxStage.  The machine sounds an alarm when he stands up, but it goes away as soon as he sits down.  I always tape him well so there is no danger of pulling a needle out, but he is still cautious.

The clinic called today and his labs from last week (before the infusion and Epo) came in.  His Hemoglobin was up to 12.8, so they have cut the dose on the Epo to .20      Suits me fine!  The less Epo the better.  He wanted to just not take it all and I would have agreed if not for wanting to be labeled "non-compliant" and the fact that .20 of Epo, once a week, is not a high dose.

We already push the limits in other areas:   He has adjusted his BP meds based on the averages for the last couple of months.  (Neph agreed with the changes after the fact.)  We have adjusted his dry weight down to 121, from the 134 where he started in Feb. and we have adjusted his off days for OUR convenience and once in March skipped three days in a row.  So far they have not said one word of criticism about anything and today the Home Nurse said, "You are doing a great job.  Keep up the good work.  He looks wonderful and his labs are very good."

Just hope he is not one of the few who does have a problem w/ Epo as he will most certainly need more later on as his kidneys contine to be destroyed by the cysts.

[Mongo]

They throw away tons of red blood cells. They don't clear the lines at the end of treatment. I know we don't want to add extra fluid, but they don't have to be bright PINK. I think it is so they can use more Epogen.

20 years ago when we didn't have Epogen those lines were clear. The only treatment for anemia was a blood transfusion.

Now they don't care.....just fill her up with Epo.

Your average nurse or tech is focused on getting patients on and off machines and/or the hell they catch if they give too much fluid back to their patients. Patients get hacked off if returning their blood "puts them behind" on their fluid restriction even before ending their treatment.

I would disagree with your "grassy knoll" conspiracy theory about what is done to use more EPO.

Mongo

[BigSky]

There is set protocol by the Amgen to how Epo and Aranesp are to be administered and Medicare too limits their payments once those desired levels are reached.

If doctors are going over those levels and keeping up with the Epo and Aranesp it seems to be it is malpractice.


Here once you go over limit they cut back dose by 25% or more as required by Medicare.

[bdpoe]

This is nothing more than PAYOLA. When you consider why this is still legal, think of the pharm lobbyists and how
much money they spend advancing and protecting their position as compared to what kind of representation
kidney patients get.  ...bd

 
Doctors Reap Millions for Anemia Drugs
 
Axel Koester for The New York Times
Bernice Wilson, 90, receiving dialysis treatment at Crescent Heights Dialysis Center, operated in Los Angeles by DaVita, a large dialysis chain. Her treatment includes a dose of Epogen, a drug used to treat anemia.

By ALEX BERENSON and ANDREW POLLACK
Published: May 9, 2007
Two of the world’s largest drug companies are paying hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly used doses.

Getting Paid to Prescribe Drugs
Do you trust your doctor to prescribe the appropriate drugs for you?

Aggressively Treating Anemia
The payments are legal, but very few people outside of the doctors who receive them are aware of their size. Critics, including prominent cancer and kidney doctors, say the payments give physicians an incentive to prescribe the medicines at levels that might increase patients’ risks of heart attacks or strokes.

Industry analysts estimate that such payments — to cancer doctors and the other big users of the drugs, kidney dialysis centers — total hundreds of millions of dollars a year and are an important source of profit for doctors and the centers. The payments have risen over the last several years, as the makers of the drugs, Amgen and Johnson & Johnson, compete for market share and try to expand the overall business.

Neither Amgen nor Johnson & Johnson has disclosed the total amount of the payments. But documents given to The New York Times show that at just one practice in the Pacific Northwest, a group of six cancer doctors received $2.7 million from Amgen for prescribing $9 million worth of its drugs last year.

Yesterday, the Food and Drug Administration added to concerns about the drugs, releasing a report that suggested that their use might need to be curtailed in cancer patients. The report, prepared by F.D.A. staff scientists, said no evidence indicated that the medicines either improved quality of life in patients or extended their survival, while several studies suggested that the drugs can shorten patients’ lives when used at high doses. Yesterday’s report followed the F.D.A.’s decision in March to strengthen warnings on the drugs’ labels.

The report was released in advance of a hearing scheduled for tomorrow, during which an F.D.A. advisory panel will consider whether the drugs are overused.

The medicines — Aranesp and Epogen, from Amgen; and Procrit, from Johnson & Johnson — are among the world’s top-selling drugs, with combined sales of $10 billion last year. In this country, they represent the single biggest drug expense for Medicare and are given to about a million patients each year to treat anemia caused by kidney disease or cancer chemotherapy.

Dr. Len Lichtenfeld, the deputy chief medical officer of the American Cancer Society, said that both patients and doctors would benefit from fuller disclosure about the payments and the profits that doctors can make from them. “I suspect that Medicare is going to take a very careful look at what is going on here,” he said.

Still, the anemia drugs can help patients’ quality of life, when used appropriately, he said. “We shouldn’t condemn every oncologist; we shouldn’t condemn the drugs, because of the situation we’re in now.”

Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. But companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment. The anemia drugs are injected or given intravenously in physicians’ offices or dialysis centers. Doctors receive the rebates after they buy the drugs from the companies. But they also receive reimbursement from Medicare or private insurers for the drugs, often at a markup over the doctors’ purchase price.

Medicare has changed its payment structure since 2003 to reduce the markup, but private insurers still often pay more. Combined with those insurance reimbursements, the rebates enable many doctors to profit substantially on the medicines they buy and then give to patients.

The rebates are related to the amount of drugs that doctors buy, and physicians that agree to use one company’s drugs exclusively typically receive higher rebates.

Johnson & Johnson said yesterday in a statement that its rebates were not intended to induce doctors to use more medicine. Instead, the rebates “reflect intense competition” in the market for the drugs, the company said.

Amgen said that rebates were a normal commercial practice and that it had always properly promoted its drugs.

“Amgen is dedicated to patient safety,” said David Polk, a spokesman. “We believe our contracts support appropriate anemia management and our product promotion is always strictly within the label.”

Both companies’ stocks fell yesterday after release of the F.D.A. report. Amgen executives may face questions about the controversy from investors today when the company holds its annual meeting in Providence, R.I.

Since 1991, when the first of the drugs was still relatively new, the average dose given to dialysis patients in this country has nearly tripled. About 50 percent of dialysis patients now receive enough of the drugs to raise their red blood cell counts above the level considered risky by the F.D.A.

American patients receive far more of the anemia drugs than patients elsewhere, with dialysis patients in this country getting doses more than twice as high as their counterparts in Europe. Cancer care shows a similar pattern. American cancer patients are about three times as likely as those in Europe to get the drugs, and they receive somewhat higher doses.