It begins: FDA may pull Avastin approval over cost concerns

posted at 12:15 pm on August 16, 2010 by Ed Morrissey

When Barack Obama and the Democrats spent most of a year pushing their deeply unpopular health-care system overhaul, they repeatedly insisted that government intervention in the market would not mean that treatment decisions would come down to cost issues — even while demonizing providers as Tonsil Vultures and amputation-happy predators.  Today, however, the Washington Post reports on an effort at the FDA to decertify Avastin as a treatment for breast cancer and its implications for cost savings at Medicare:

Federal regulators are considering taking the highly unusual step of rescinding approval of a drug that patients with advanced breast cancer turn to as a last-ditch hope.

The debate over Avastin, prescribed to about 17,500 women with breast cancer a year, has become entangled in the politically explosive struggle over medical spending and effectiveness that flared during the battle over health-care reform: How should the government balance protecting patients and controlling costs without restricting access to cutting-edge, and often costly, treatments? …

The FDA is not supposed to consider costs in its decisions, but if the agency rescinds approval, insurers are likely to stop paying for treatment.

“It’s hard to talk about Avastin without talking about costs,” said Eric P. Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston. “For better or worse, Avastin has become in many ways the poster child of high-priced anti-cancer drugs.”

Avastin got approved through a fast-track process demanded by Congress several years ago when complaints about the length of getting new treatments approved reached a fever pitch.  Subsequent testing has called into question some of the assumptions made about Avastin, particularly about the effectiveness in delaying advanced tumor generation in breast cancer.  However, others note that the drug works for a large number of women, even if it doesn’t necessarily work for them all:

“I’m very upset,” said Leslie Twohig, 48, of Lothian, Md., who has been taking Avastin for eight months and credits the drug with helping her survive. “How long will I be able to stay on Avastin? Are they going to take it away? I know it’s working for me. Right now I am able to enjoy my life. Every morning I wake up and wonder how long it’s going to go on.”

“I am very concerned about people who are receiving the drug and may feel threatened that they may not be able to receive it,” said the Dana-Farber Cancer Institute’s Winer, who is also chief scientific officer for Susan G. Komen for the Cure, a breast cancer patient advocacy group. “This is not a worthless drug by any means. There is almost certainly a group of women who get a big benefit. “

Would the FDA even be re-reviewing Avastin for its application to breast cancer without the cost issue?  I’m skeptical.  As the Post notes, the FDA doesn’t do a lot of follow-up on fast-tracked approvals.  Avastin didn’t just get lucky to get renewed attention from the FDA.

With the new ObamaCare regime in place, the issue of cost has now become openly part of the FDA process.  This is a perversion of their mission, which is supposed to only involve product safety and effectiveness, not bean-counting.  If Medicare doesn’t want to cover Avastin, that should be a separate issue handled by CMS and HHS.  This strongly suggests that the FDA has become politicized to a degree where their recommendations lose credibility — a dangerous situation for consumers and providers alike.


Related Posts:

Breaking on Hot Air

Blowback

Note from Hot Air management: This section is for comments from Hot Air's community of registered readers. Please don't assume that Hot Air management agrees with or otherwise endorses any particular comment just because we let it stand. A reminder: Anyone who fails to comply with our terms of use may lose their posting privilege.

Trackbacks/Pings

Trackback URL

Comments

Comment pages: 1 2 3

http://www.telegraph.co.uk/health/healthnews/7948878/US-breast-cancer-drug-decision-marks-start-of-death-panels.html

UK weighs in on this topic and titles the column as the start of … death panels!

ted c on August 17, 2010 at 5:50 AM

Develop your own cancer drug?

Inanemergencydial on August 16, 2010 at 11:56 PM

So you are fine with the cost of everything right? Groceries, auto parts, gas, electrical bills… everything right? You are the quintessential free marketeer….

I find it hard to believe any American would approve but hey when ideology is in play…well.
Oh and just as an aside…. I was speaking to the idea of the Feds paying whatever “companies” demand. Pay attention.

dartagnansblade on August 17, 2010 at 7:03 AM

dartagnansblade on August 17, 2010 at 7:03 AM

The cost of those things, groceries, auto parts, etc.etc. are the same for everyone. The odd thing is that they are probably both subsidize and taxed in ways that make the price artificial. It’s still not the point of the argument and this drug isn’t the perfect example but the FDA is for the approval of drug safety and purpose, not whether it will be prescribed by Medicare or Medicaid. To withdraw approval for this drug makes it more expensive.

Cindy Munford on August 17, 2010 at 7:33 AM

If the FDA does this can we safely say “death panels” are alive and well? Not only that, I can see countless ads by trial lawyers telling people they can “get money” if they used this and had adverse effects (real or not). And we wonder why our medical insurance goes up in price?

Wills on August 17, 2010 at 9:10 AM

I wasn’t clear enough that I was talking about two separate issues. First, the politicized approval of Avastin for breast cancer treatment. Ed is wrong that it’s up for the chopping block over cost concerns. There have been concerns over the effectiveness of the drug from the beginning.

Second, I believe that if we’re going to have government-run insurance — which you explained how it isn’t insurance at all — then the fiscally conservative thing to do is not to cover long-shot therapies.

Basically, I’m saying that death panels are the opposite of the real problem with Obamacare. Everyone seems to be jumping on this example, which hasn’t even happened yet, as vindication of Sarah Palin. But watch the drug get approved by the FDA because the Democrats don’t want to have to watch ads about how they’re against treating breast cancer. The government — and every government agency will have to be involved — is going to find excuses to cover things that any insurance company that wanted to stay in business would have to charge more for.

RightOFLeft on August 16, 2010 at 7:29 PM

Again, you take it for granted that teh cost concerns are not what is driving this by the FDA – and even your own comments are about the cost and not whether the drug works. The article strongly implied that FDA was reviewing this drug b/c of cost concerns. taht should not happen. the FDA has no place in even thinknig about cost concerns. It does not matter if a drug only helps 1% of the population and costs $10 million a pill. If it is safe and effective and does help 1% – then it should be approved.

Whether or not policies and even medicair or medicaid actually cover the drug is a different question. You still seem to be conflating the 2 questions. I agree that the decision whether or not to cover a long-shot treatment drug is up to the insurer for the particular policy.

However, it is not up to FDA to determine that a long-shot drug (i.e., one that only helps 1% of the population or only extends life by a few months) should not be approved because it is too costly for too little benefit. Again, FDA has no business making that decision. FDA is supposed to make a medical/scientific decision as to teh safety of teh drug and whether it does what it claims (i.e., if it claims to help 1% of the population it does what it claims). The FDA is not supposed to be making political / budgetary decisions regarding the cost/benefit of a drug.

Monkeytoe on August 17, 2010 at 9:25 AM

to clarify my last, in a number of comments you state that the drug is not effective because it ONLY extends life for some women a couple of months and/or only works in a small number of women, but costs a lot. That is not a medical/scientific analysis of whether the drug is beneficial to some degree and safe. That is a cost/benefit analysis as to whether the drug is worth the cost for the benefit received. That is exactly what the FDA should not consider.

There are plenty of drugs on teh market that have limited benefit – i.e., only help a small percentage of people, only have limited effect, etc. So that is no reason for the FDA to take away approval. If the only reason is that the cost outweighs the benefit, that is not an FDA decision, that is a decision for Medicare to make. Taht is a decision for insurance companies to make. That is not a decision for FDA to make.

Monkeytoe on August 17, 2010 at 9:29 AM

And, again, I’m not disagreeing that it may be rational for Medicare or private insurers to decide that the cost/benefit analysis makes this drug too costly to cover. I don’t know the science behind this drug to have an argument either way. I am simply stating that this is not FDA’s decision to make.

Monkeytoe on August 17, 2010 at 9:30 AM

Also, if in fact avastin’s health risks outweigh any potential health benefit, that is a different matter. Obviously, that would be in FDA’s purview. But the initial article and most of the arguments presented in the comments were regarding the cost versus the benefit, not health risks versus health benefit.

Monkeytoe on August 17, 2010 at 9:39 AM

Has anyone seen a reasonable reason this drug is so expensive? I understand delevopment but $8000?

Wade on August 17, 2010 at 10:13 AM

Wade on August 17, 2010 at 10:13 AM</blockquote

A one day hit of radiation cost $2500 before insurance. And one day won't do the trick. How many times has the equipment been paid for?

Cindy Munford on August 17, 2010 at 10:29 AM

Also, if in fact avastin’s health risks outweigh any potential health benefit, that is a different matter. Obviously, that would be in FDA’s purview. But the initial article and most of the arguments presented in the comments were regarding the cost versus the benefit, not health risks versus health benefit.

Monkeytoe on August 17, 2010 at 9:39 AM

Um, darling, generally when people are put on Avastin, there isn’t much hope for them to survive many, many years. Cancer patients are put on Avastin as a last-ditch effort to extend their lives a tiny bit.
Essentially, your talk of health benefits is irrelevant in this case BECAUSE THERE AREN’T ANY.

That said, the reason they are talking about pulling the approval is so that Medicare and Medicaid will stop paying for it. Next up: Lupron. And many, many other cancer drugs. And probably some of the HIV/AIDS treatments.

Don’t fool yourself. This is a cost containment effort. That is all.

mjk on August 17, 2010 at 10:53 AM

You haven’t heard much after the first suggestion was to stop giving routine mammograms to women in their 40′s last year. Now this.

What’s in store for men, since the “task force” also opposes PSA screenings for older men. Will the FDA also pull a last-ditch drug for prostate cancer?

moonsbreath on August 17, 2010 at 11:12 AM

Has anyone seen a reasonable reason this drug is so expensive? I understand delevopment but $8000?

Wade on August 17, 2010 at 10:13 AM

Biotech drugs are derived from genetically modified organisms. It’s not like a chemical where once you have the formula you can synthesize it en masse. They also have very short shelf-life, which increases logistic costs.

year_of_the_dingo on August 17, 2010 at 11:38 AM

The loss of Avastin could mean a loss of all sorts of technology that strikes directly at the cancer cells – there wouldn’t be a cure for “cancer” but theoretically, R&D from Avastin could lead to eradication of specific cancers and/or the ability to lead long, normal, healthy lives with specific cancers.

quiz1 on August 17, 2010 at 12:00 PM

No, those who died during the Avastin trial died from heart failure. The drug has really serious side-effects. What kills the cancer cells kills the patient too. That’s no data suggesting that Avastin prolong the lives of breast cancer patients. It stops cancer growth, but it causes the perforation of the stomach among other things.

year_of_the_dingo on August 16, 2010 at 11:23 PM

So, the article is wrong in it’s assumptions, and it is a dangerous drug. Sounds like you need to be berating the Wash Post for sloppy reporting, not the commenters on their reactions.

Also, Avastin isn’t the only treatment option that has bad side effects. My wife is on Glucophage for blood sugar control, and it attacks the liver. She needs blood work done every 6 months to determine if there is any liver damage. Should they pull that, too?

Phil-351 on August 17, 2010 at 12:12 PM

Um, darling, generally when people are put on Avastin, there isn’t much hope for them to survive many, many years. Cancer patients are put on Avastin as a last-ditch effort to extend their lives a tiny bit.
Essentially, your talk of health benefits is irrelevant in this case BECAUSE THERE AREN’T ANY.

mjk on August 17, 2010 at 10:53 AM

If it extends life, there is a health benefit. Whether the economic cost of that benefit outweighs the actual benefit, is not for FDA to decide. I have said that all along.

Monkeytoe on August 17, 2010 at 2:30 PM

So, the article is wrong in it’s assumptions, and it is a dangerous drug. Sounds like you need to be berating the Wash Post for sloppy reporting, not the commenters on their reactions.

I’m not sure the article had sloppy reporting. They suggested that there were those who were against Avastin and those who were for it.

The article did have this quote:
‎”I am very concerned about people who are receiving the drug and may feel threatened that they may not be able to receive it,” Eric Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute, said. He added, “This is not a worthless drug by any means. There is almost certainly a group of women who get a big benefit.”

redeye on August 17, 2010 at 2:38 PM

All drugs I have ever taken or read about have SOME actual or potential side effects: some of these side effects are deadly.

But that is not an argument to ban these drugs. The relevant question is:

Are the risks associated with this drug commensurate with the benefit to the patient?”

We DONT want the FDA or any other government agency making the decision as to whether the drug is “worth it”!!! That decision belongs exclusively to the patient and his family.

Our founding fathers designed a country with “government OF THE PEOPLE.” If we allow government to tell its citizens when their lives are “worth it,” we will have “people OF THE GOVERNMENT” instead.

landlines on August 18, 2010 at 11:18 AM

By the way, has anyone else noticed the government-inspired push to make MRI’s, CAT scans, and other computer-assisted diagnostic technologies less available?

If the government’s focus was “excellent health care” instead of “lower cost to the government,” then there would be an effort to use more of these computer-assisted diagnostic techniques in order to improve diagnostic accuracy.

With more deployment and use, the cost of computer-assisted diagnostic technologies would come down drastically, just like all other computer applications. This would allow us to replace obsolete, hard to read, and potentially dangerous XRAY machines in the offices of primary care doctors with something much more effective and safer for the patient.

Artificially keeping these tools scarce guarantees higher costs!!

Because the government has a perverted view of what the purpose of “health care” is, government is actually standing in the way of medical progress.

landlines on August 18, 2010 at 11:33 AM

Imagine if you put a life saving drug on a scale from
$4/month Walmart generic to a 100,000.00/month experimental.

How much do you think life is worth.

Should insurance companies spend an unlimited amount on a drug that will preserve peoples lives a few years?

Most people I know won’t even eat right or exercise but expect unlimited medical care to overcome years of smoking, donuts and laziness.

I think third party payments are the genesis of med cost problems. If everyone had to pay cash on the barrel head. Medicine would be 1/10th the current cost.

esnap on August 18, 2010 at 12:51 PM

Comment pages: 1 2 3