DALLAS – February 3, 2012 – We want to apologize to the American public for recent decisions that cast doubt upon our commitment to our mission of saving women’s lives.  The events of this week have been deeply unsettling for our supporters, partners and friends and all of us at Susan G. Komen.  We have been distressed at the presumption that the changes made to our funding criteria were done for political reasons or to specifically penalize Planned Parenthood.  They were not.

Our original desire was to fulfill our fiduciary duty to our donors by not funding grant applications made by organizations under investigation.  We will amend the criteria to make clear that disqualifying investigations must be criminal and conclusive in nature and not political. That is what is right and fair.

Our only goal for our granting process is to support women and families in the fight against breast cancer.  Amending our criteria will ensure that politics has no place in our grant process.  We will continue to fund existing grants, including those of Planned Parenthood, and preserve their eligibility to apply for future grants, while maintaining the ability of our affiliates to make funding decisions that meet the needs of their communities.

Read the rest  of the statement here.

The Susan G. Komen for the Cure Foundation, a well known breast cancer-fighting charity, decided to withhold further donations to the abortion provider for several reasons, one of which is that Planned Parenthood is under investigation by Congress for violating various state abortion laws.

Last month, the Associated Press reported Komen’s new criteria and why it is excluding PP. “Komen spokeswoman Leslie Aun said the cutoff results from the charity’s newly adopted criteria barring grants to organizations that are under investigation by local, state or federal authorities,” the report said. “According to Komen, this applies to Planned Parenthood because it’s the focus of an inquiry launched by Rep. Cliff Stearns, R-Fla., seeking to determine whether public money was improperly spent on abortions.”

The foundation gave more than $569,000 to Planned Parenthood in 2010.

As to the charges against Planned Parenthood that are pending in the congressional investigation, you might recall the stellar work of Lila Rose, whose videos brought to our attention that Planned Parenthood was violating state laws by ignoring requirements to report child abuse and rape while pushing abortions on minors.

But Planned Parenthood apparently isn’t taking this lying down. They aren’t just lamenting Komen’s decision; they are getting mad.

In a fundraising letter emailed to supporters, the abortion provider proved themselves to be less a “healthcare” organization, and more the ideologically driven advocacy group that detractors say they are. The email is blunt and asks supporters to sign onto the extremist rhetoric and send it on to others. Most interesting, the letter doesn’t just attack opponents in general but specifically attacks women that oppose Planned Parenthood.

Here is the text of that shockingly harsh letter:

This is for all the anti-choice, anti-women people out there.

Listen up.

You can spend every minute of every day trying to force the rest of us to live by your ideology. You can go after federal funds for health care and pressure private organizations like the Susan G. Komen for the Cure Foundation to stop funding breast cancer screenings for poor women. You can try to make it impossible to get birth control.

But you know what you can’t do? You can’t win. You can’t break us. Planned Parenthood isn’t just a family of organizations. It’s a movement. It’s women and men of all ages who believe that health care — including reproductive health care — is a basic human right. We are millions strong. We are everywhere. We act, we give, and we do whatever it takes to make sure that Planned Parenthood is there for the women, men, and teens who rely on them.

Know this: When you go after Planned Parenthood and the people they serve, you go after ME. I stand with Planned Parenthood. I stand with them against anyone who wants to stop women from receiving the health care they need. I stand with them today, tomorrow, and for as long as I need to.

I don’t now about you, but I don’t think I’ve ever seen a fundraising letter like this supposedly emanating from a “health care” organization. Imagine if a hospital or other medical organization sent such a letter as this to its customers.

Also amazing is the bald attack on women who don’t agree with PP. This also proves that they aren’t an organization interested in women but one only interested in women that agree with their ideologically extreme position on abortion.

In any case, what we seem to be seeing here is the last bit of a veneer of legitimacy ripped from Planned Parenthood. It is now fully embracing its ideological drive toward infanticide and has cast away any pretext that it is at all interested in mere healthcare. With this letter Planned Parenthood is admitting that it is a “movement,” not a healthcare provider.

US health officials on Friday revoked the authorization of Roche’s Avastin for breast cancer treatment, saying it concluded the drug had “not been shown to be safe and effective for that use.”

Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer, the US Food and Drug Administration said in a statement.

Original story here. Avastin has been shown to improve the quality of life for Stage 4 cancer patients, extending life by several months. FDA felt the additional several months of life wasn’t enough justification for the treatment. The FDA move will trigger private insurance companies to drop the drug from their coverage plans.

Unfortunately for patients, the FDA has adopted a Marxist position on the issue – not Karl Marx but Groucho Marx.  Groucho Marx once quipped, “who are you going to believe me or your lying eyes?”

Supporters of the FDA’s proposal to limit access to the drug to those who can pay for it out of pocket, argue that since the drug does not affect all patients the same way, the government should save health care costs by moving to deny insurance coverage.  That is the basis of rationing and the basis of ObamaCare.

The FDA and their apologists like oncologist Fred Tucker, who took to the New York Times to defend the agency, argue the law of averages ignoring the reality that some patients respond better than others.  Greg Conko brilliantly responded to their arguments at OpenMarkets.org in an article entitled “The Medium is not the Message.”

Conko retorted:

Technocrats, including Dr. Tucker, have applauded the decision, arguing that Avastin doesn’t work very well, and that it has significant side effects. On the other side are patient advocates and thousands of women who have benefited from the drug, who argue that it’s unfair for the agency to take away an option for patients who are at risk of dying. ”We want to be sure that women who are using Avastin, and for whom it is working, can continue to have access to it,” said Elizabeth Thompson, president of Susan G. Komen for the Cure. The real question ought to be, who gets to decide?

The biggest weakness in the FDA’s case is its reliance on average or median effectiveness. What averages don’t reveal, however, is the fact that some patients respond to a treatment option much better than others. Particularly when it comes to a life-threatening illness, average or median survivability too often masks the fact that some patients respond very well indeed. Pop scientist Stephen Jay Gould made this point quite eloquently in a 1985 essay published in Discover magazine, titled “The Median Isn’t the Message.” In 1982, Gould was diagnosed with a rare form of lung cancer, which he discovered had a median survival time of just eight months. His doctor had given up on him because of the dire prognosis, but Gould actually lived another 20 years, and then died of a different type of cancer. In his Discover essay, Gould wrote:

[A]ll evolutionary biologists know that variation itself is nature’s only irreducible essence. Variation is the hard reality, not a set of imperfect measures for a central tendency. Means and medians are the abstractions. Therefore, I looked at the mesothelioma statistics quite differently – and not only because I am an optimist who tends to see the doughnut instead of the hole, but primarily because I know that variation itself is the reality. I had to place myself amidst the variation.

When I learned about the eight-month median, my first intellectual reaction was: fine, half the people will live longer; now what are my chances of being in that half. I read for a furious and nervous hour and concluded, with relief …  I knew how to read the data properly and not despair.

Just like Gould’s doctor, the FDA and its technocratic supporters are giving up on cancer patients because of their slavish obsession with median response rates. Sure, on average, Avastin may not extend a patient’s life expectancy, but you don’t have to be Garrison Keillor to realize that some people really are above average. The expected value, a priori, of the treatment for any given patient does indeed appear very small, so you can understand why a health plan would balk at paying the very high price for Avastin (which varies from about $56,000 to $96,000 per year). But making cost-effectiveness calculations isn’t FDA’s job — nor does the Food, Drug and Cosmetics Act even permit the agency to consider the price. Consequently, the FDA had no business removing the breast cancer indication from Avastin’s label, and anyone who values freedom and self-determination should hope the decision is reversed next month.

There is a reason why patients, led by Terry Kalley the husband of a breast cancer survivor will travel to Silver Spring to protest the FDA’s attempt at rationing – their lives depend on it.  To contact Kalley or help spread the word of the patient’s protest, you can email him at AvastinProtest@Yahoo.com.

Not many can.

There are thousands of women who rely on the drug for their survival. Without it, they will die. That fact has prompted a small businessman from Michigan to put his life on hold to fight “the man.” In this case, “the man” is the bureaucrats at the FDA who are on a mission to cut health care costs. If their proposal to “de-label” Avastin becomes reality, Medicare and private insurance companies will no longer have to cover the cost of the drug. In the eyes of ObamaCare proponents – society wins.

But families lose. In fact, the impact on families will be devastating – a death sentence says Terry Kalley, the husband of a breast cancer patient who relies on Avastin to live.

Kalley is organizing a rally against rationing in Silver Spring, Maryland on June 28th at the FDA final appeal hearing.

Taking on the federal government is no easy task but Kalley is not backing down. Despite his efforts, he cannot do it alone. He will need your help, support and prayers.

So, to all in the Virginia, Maryland and DC area who care about the future of healthcare in America – this is a rally worth participating in.

To join the protest contact Kalley at his organization, Freedom for Access to Medicines: http://www.fameds.org/protest.php or for more info, email avastinprotest@yahoo.com

In fact, it may be too late.  Rationing is creeping into the system already.

The Wall Street Journal highlights the latest efforts to “end the cost curve,” this time in Washington State where bureaucrats could decide whether it is “too expensive” to treat kids with diabetes. The Journal in a critical editorial notes:

In 2006, Washington created a board to scrutinize the cost-effectiveness of various surgeries and treatments, known as the Health Technology Assessment program. At a hearing today, the panel will debate glucose monitoring for diabetic children under 18. In other words, the board is targeting the fundamental standard of diabetes care that has been the established medical consensus for at least three decades.

This state issue deserves far more scrutiny, if only because ObamaCare and the stimulus devoted billions of dollars to comparative effectiveness research. As President Obama has so often put it, the idea is to pit Treatment X against Treatment Y and find out “what works and what doesn’t.” In theory, it sounds great. But the Health Technology Assessment is an example of how comparative effectiveness will work in the real world, as the political system tries to find ways to restrict or limit treatment to control entitlement spending.

Of course, Washington State’s effort to reduce the cost of health care is the tip of the rationing iceberg.

The Food and Drug Administration (FDA) is trying to restrict the drug Avastin to breast cancer patients who can afford to pay the $80,000 a year treatment themselves.  Women who depend on insurance to cover the cost of the drug will be on their own should the FDA move forward with their initial recommendation.

Provenge is a prostate cancer drug that has been found to be an effective treatment but the Centers for Medicare Medicaid Services (CMS), headed by rationing supporter Donald Berwick has conducted a review of the drug because of its price tag.  “CMS will never admit that cost is a part of the reason they opened up the national coverage decision, but I think it definitely is,” said David Blaszczak, a Potomac Research Group analyst who previously worked for the agency. “If this product was only $200 we wouldn’t be going through this process.” (http://www.usatoday.com/yourlife/health/medical/cancer/2010-11-18-provenge-medicare_N.htm)

Lucentis is another example where the bottom line cost is trumping patient concerns.  The drug has been FDA approved for patients with Wet Age Macular Degeneration (AMD) eye disease.  It was tried, tested and proven safe for patients but the National Institute for Health is undertaking its own study to see if Avastin – which was never approved for AMD – can be substituted in its place.  Patient safety be damned when price is the issue.

Even though ObamaCare was enacted just one year ago, we are starting to see rationing creep into our health care system.  Things will only get worse should the law not be repealed.

In June 2010, a subpanel at the FDA recommended that the late-stage cancer drug Avastin be denied insurance and Medicare coverage for breast cancer patients.  Cost was specifically mentioned as a reason for the decision.  “De-labeling” the drug will save Medicare the burden of paying for the drug that can run $80,000 a year.

Despite protests from thousands of breast cancer patients who cannot afford the treatment without insurance, the FDA approved the panel’s recommendation in December.  Patient groups like Susan B. Komen and Cancer101 have now entered the ring arguing that decision – if it becomes final – will have dramatic implications for the future of our health care system.  They are pleading for the FDA to reverse itself.

Now the European Union health care advisory committee– a bastion of socialist medicine and open rationing of care – has found that Avastin in combination with chemotherapy helps women with metastatic breast cancer live longer without their disease worsening.  That is exactly what American cancer patients and doctors have said all along.

The Wall Street Journal reports:

“The committee’s decision stands in stark contrast to the recent verdict by the U.S. Food and Drug Administration, which is wary of Avastin’s benefits for breast-cancer patients. While the FDA plans to revoke approval of Avastin, the U.S. regulator has granted Roche a hearing later this year, though analysts say the Swiss drug maker is unlikely to change the U.S. watchdog’s views. Patient groups are lobbying the FDA to change its stance as Avastin is one of the rare cancer drugs to help breast-cancer patients. Breast cancer is the most common cancer among women world-wide, with more than one million new cases diagnosed every year, killing nearly 400,000 people….The verdict by the European Commission—the EU’s executive arm—is unlikely to change the increasingly stricter drug-approval rules by regulators, analysts say.”

It’s clear that the “stricter” FDA will have dramatic impact on the future of America’s health care.  Patients need more treatment options not less.  Allowing patients access to a drug – if they can afford it – is a staple of government-run health care systems throughout the world.  With regard to breast cancer patients, the FDA is out rationing the rationers.