Posts Tagged ‘FDA’

Lawrence Meyers

The Brazilian Blowout Hoax, Epilogue: What It Means To All of Us

by Lawrence Meyers


SAFE. End of story.

Please read Part 1, Part 2, Part 3, and Part 4 [Editor: Please link to each]

Contrary to recent media reports, the Brazilian Blowout hair treatment is safe for use.  Here is a review of all the studies done on Brazilian Blowout.

Oregon OSHA:  Pass

Federal OSHA:  Pass

Health Sciences Associates:  Pass

Dr. James Haw – USC: Pass

FDA:  Conducted no studies

ChemRisk: Too much product used = faulty study

Brazilian Blowout passed every single properly performed study for both state and federal short-term and long-term exposure limits, known as the Permissible Exposure Limit (PEL – an 8-hour time-weighted average) and Short-Term Exposure Limit (STEL – a 15 minute exposure measurement).

So why the witch hunt on Brazilian Blowout?  The answers are simple:

1) Government Bias

As described in Part 1 [Editor: Please link], Oregon OSHA is guilty of :

  • Equating methylene glycol with formaldehyde in contradiction of all accepted scientific nomenclature methods.  Doing so allowed them to…
  • Claim extremely high levels of formaldehyde in the product.
  • Ideological bias, as at least one scientist who authored the study aligns himself with a hardcore Liberal Senator known as an environmental activist.
  • Editorializing what should be a neutral scientific report, thus demonstrating its own bias.
  • Deliberately taking samples longer than 15 minutes and applying those results to 15 minute periods.
  • Issuing a false and misleading press release that did not report the product actually passed the PEL and STEL tests.

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Lawrence Meyers

The Brazilian Blowout Hoax Part 3: Politicians and The FDA Attack a Safe Product

by Lawrence Meyers

Please read Part 1 and Part 2.

Contrary to recent media reports, the Brazilian Blowout hair treatment is safe for use.

Oregon OSHA and Federal OSHA had already attacked Brazilian Blowout’s product, steering the media to focus on faulty aspects of their respective studies, and burying the truth  –  that the product does not release formaldehyde in amounts that exceed state or federal short-term or long-term exposure limits.

Enter Rep. Earl Blumenauer (D – 3 – OR).  Ontheissues.org labels him a “hard-core Liberal”, and you know what that means when it comes to anything involving chemicals or the environment.   Rep. Blumenauer sponsored nonsensical bills like HR 3311 that taxes drivers based on miles driven; a ludicrous bill to jump-start the funding of streetcars; a bill to establish under-the-radar death panels; a bill providing environmental education grants for outdoor experiences (huh?); and even one quashing free speech by attempting to ban a website promoting the perfectly safe Yucca Mountain nuclear waste dump.

So Rep. Blumenauer reads about OSHA’s nonsense in the media and, because he’s a politician, doesn’t do his research, either.  Nor does he bother contacting the company to get their side of the story.   Instead, he grandstands by penning a letter to the Food and Drug Administration asking that they recall the product — a product already proven to meet OSHA standards!

I asked Rep. Blumenauer’s press secretary, Derek Schlickeisen, about this approach to policy.  His assertion was that politicians “can’t have a chemist on staff”, and thus rely on OSHA’s scientists to bring incidents like this to light.  When I mentioned that the company-funded study by Health Science Associates showed formaldehyde levels below OSHA standards, he inferred that the study held little weight because it was company funded.

Yet why is it that OSHA’s results are given any more credibility, especially when OSHA caused a panic based entirely on a faulty sample?  Are we to believe that OSHA scientists are somehow free of ideological bias?  Kermit McCarthy, one of the authors of the Oregon OSHA study, “likes” hard-core Liberal Sen. Ron Wyden according to his Facebook page.  Why isn’t his bias questioned?  If anything, a government worker is likely more biased than a private company to insert bias, because his very job depends on his work generating a result that permits the government to do something.  Otherwise, the agency’s existence, and the employee’s, have no purpose.

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Publius

ObamaCare Rationing: US Revokes Avastin for Breast Cancer Treatment

by Publius

From AFP:


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.”

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Publius

FDA Grants Company Monopoly on Ancient Drug

by Publius

From CBSNews:


Colchicine has been used to treat gout and other inflammatory conditions for thousands of years. How could one company gain a monopoly?

There are about 1,000 medications on the market that predate the existence of the Food and Drug Administration and therefore were never approved. FDA official Deborah Autor spoke to CBS News as head of the office of unapproved drugs. “Well, for me, unapproved drugs present current risks,” Autor said. “We don’t know what’s in them. We don’t know if they’re going to work properly. We don’t know how they’re made and that’s a real concern.”

Hundreds of thousands of people take Colchicine each year. The FDA said over the past 40 years, 169 deaths have been linked to the medication. A company called URL Pharma decided it would take the ancient drug, sold for 10 cents a pill, and test it as part of an FDA program to either approve these drugs or get them off the market.

“One company chose to seek FDA approval and they spent tens of millions of dollars in order to present data necessary for that approval and in the process, there were some important things that came out of the approval process,” Autor said. “We discovered a lot of people were being excessively dosed with Colchicine.”

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Capitol Confidential

Google Caught with Hand in Cookie Jar

by Capitol Confidential

There is one thing you can say about Google – they don’t give a damn. They don’t care about intellectual property rights. They don’t care about privacy of their users. And they don’t appear to care about the law in general.

Google has been fined an incredible $500 million by the Department of Justice for knowingly and illegally assisting Canadian pharmacies illegally importing drugs into the United States.

Google has admitted that as early as 2003 they were made aware that it was illegal for pharmacies to ship controlled and non-controlled prescription drugs into the United States from Canada. But Google facilitated the sales and importation of these drugs by marketing their AdWords program to Canadian pharmacies.

The Food and Drug Administration (FDA) takes the position that they cannot ensure the safety and effectiveness of foreign prescription drugs. In fact, even though Canada has its own regulations regarding drug safety, Canadian pharmacies that ship prescription drugs to U.S. residents are not subject to Canadian regulatory authority, and many sell drugs obtained from countries other than Canada that lack adequate pharmacy regulations.

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Reason TV

The FDA’s New and Improved Cigarette Warning Labels

by Reason TV

The US Food and Drug Administration recently unveiled nine graphic warning labels that will appear on US cigarette packs in 2012. Some of the more gruesome labels include images of diseased lungs and tracheotomy holes. According to the FDA, these labels are “the most significant advancement in communicating the dangers of smoking and the first change in cigarette warnings in more than 25 years.”

Will the graphic labels reduce smoking? Do Americans really need to be reminded that smoking isn’t good for them?

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Christopher C. Horner

Breathless: FDA Bans Asthma Medication

by Christopher C. Horner

Remember when Barack Obama – with the dignity and off-prompter grace, evincing deep understanding of the issues and the eloquence for which he is fawned over by the media – offered this gem:

Everybody knows that it makes no sense that you send a kid to the emergency room for a treatable illness like asthma, they end up taking up a hospital bed, it costs, when, if you, they just gave, you gave them treatment early and they got some treatment, and a, a breathalyzer, or inhalator, not a breathalyzer. (crowd laughing) I haven’t had much sleep in the last 48 hours.

Here he was promoting his health care takeover, though he and his also invoke children with asthma to push his global warming, anti-energy agenda — asthma being on the rise as emissions from cars and coal-fired power plants dramatically declined; obviously emissions from coal-fired electricity and cars air pollution must be the culprit. Or something. Expect to see a few in the debt-ceiling fight.

Well, things do get more confused with his own administration guilty of escalating a war on these breathalyzers or inhalators or gassificationators. You see, the best and cheapest inhalers have been phased out because their propellants are Chlorofluorocarbons (CFCs), substances targeted as ozone depleting substances. Replaced with extraordinarily powerful greenhouse gases, incidentally. Necessitating a…war on coal-fired electricity. Wash, rinse, repeat.

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Reason TV

Reason.tv: Q&A with Farmageddon’s Director Kristin Canty

by Reason TV

Guns drawn, a SWAT team kicks in the door of a private business. Are the cops there for drug dealers? Mafia mobsters? Terrorists?

No, the long arm of the law is out for the real dangerous contraband: raw milk and grass-fed chickens.

Nick Gillespie sits down with Kristin Canty, director of Farmageddon: The Unseen War on American Farms, a new documentary about small farms and co-ops that have been raided by the Food & Drug Administration, the U.S. Department of Agriculture, and state-level agencies and have had their products seized and destroyed. One particularly gruesome case involved a flock of sheep being killed because of the non-existent threat of the sheep acquiring Mad Cow Disease.

Farmageddon does more than document government overreach; the movie also takes issue with FDA claims that raw milk and other products popular with foodies are unsafe and filled with dangerous bacteria. In a country where more and more folks are embracing small-scale and organic agriculture, the government is on a collision course with a growing subculture.

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Capitol Confidential

Who Gets to Decide Our Health Care?

by Capitol Confidential

On June 28th and 29th in Silver Spring, Maryland, cancer patients and their families will gather in protest of the Food and Drug Administration’s (FDA) effort to ration the late-stage breast cancer drug Avastin.  These patients credit the drug for extending their lives well beyond what was to be expected.

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?

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Capitol Confidential

Protesting for Life

by Capitol Confidential

It’s not often that the outcome of a protest could be a life or death decision, but that is the position that thousands of women with breast cancer find themselves thanks to a proposal by the Food and Drug Administration (FDA) to limit access to the drug Avastin only to those who can afford to pay for it out of their own pocket.

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.

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Kerri Toloczko

Mugging Soap: The Left Finds Cash In Bubbles

by Kerri Toloczko

“In recent injury/product liability news, the National Resources Defense Council (NRDC) filed a lawsuit against the FDA alleging it failed to regulate toxic substances in certain consumer products.”

Thus began the latest manufactured consumer crisis illustrating the powerful union between radical environmentalists and the trial bar.   Add a sympathetic Congressman and a manipulative triad is born.

Product liability wrangling follows a clear path – first the setup, then vague accusations of the product’s damaging properties followed by class action cash flow.

In just one sentence, the above blog comment posted by Texas personal injury law firm captures the essence of how product liability wrangling starts – and, ultimately, why.

Despite a forty-year record of reducing germs, slowing their transfer and being deemed safe by the FDA and EPA, the latest victim of the NRDC and friends are antimicrobial products – particularly those with ingredients Triclocarban and Triclosan.

These synthetic antimicrobial agents kill or retard the growth of fungus, mildew and bacteria in commercial and consumer products including hand soap, toothpaste, cosmetics, restaurant equipment, air conditioning coils, surgical scrubs and the Swiss Army Knife.

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Capitol Confidential

Rationing By All Means Necessary

by Capitol Confidential

The most instructive part of the president’s “deficit” speech last week was his insistence that he could help balance the budget through an “independent commission” with the “authority to make additional savings by further improving Medicare.”  That commission is the Independent Payment Advisory Board (IPAB) and it is nothing more than another leg in ObamaCare’s rationing stool.

Writing in the Weekly Standard, Mark Hemmingway writes:

Here’s how IPAB works. It’s a panel comprised of 15 presidential appointees who are tasked with reducing Medicare spending. The panel is is given certain spending targets that kick in in 2014. At first those targets are on a sliding scale, but by 2018 the spending targets are set at the rate of GDP growth with an additional half of a percentage point tacked on. (Originally, it was GDP plus a full percentage point, but according to the “framework” released prior to the President’s speech the spending target has been reduced.)

Any recommendations IPAB makes about Medicare spending automatically become law. Congress can only override IPAB with a three-fifths majority vote, which is a very high legislative hurdle, or they can pass their own Medicare plan that meets the same spending target. There’s no administrative process for doctors or citizens to challenge the board’s decisions. There’s a school of thought that says IPAB is even more blatantly unconstitutional than the individual mandate, as its power sounds legislative in nature — its declarations would have the force of law — and therefore cannot legitimately be delegated to an executive entity.

In short, the IPAB would give power to unelected bureaucrats the make life or death decisions about Medicare – and probably private insurance – coverage without any way for patients to challenge the decision of the board.  Rationing would be implemented without a vote of Congress.

Writing in the National Review, James Capretta, points out that the Administration will not only use the panel to ration care but it’s real purpose is to build a stepping stone toward a nationalized health care system.

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Capitol Confidential

Wasteful Program Treats Catfish Like Al-Qaeda

by Capitol Confidential

Individual earmarks may have swum upstream for the winter, but there’s still something very fishy going on with Congress in terms of spending. Despite all the discussion about austerity and countless campaign promises to cut spending, the crafters of the Continuing Resolution let stand a rulemaking policy no one can be proud of: a special interest-driven program that will create over 100 new government employees, more red tape, and hundreds of millions of new federal spending, without any benefit to taxpayers…all for – you guessed it – a fish.

You may have thought that Ted Stevens’ giant salmon of a private plane was the most spectacular fish-related waste of taxpayer dollars in history, but you’d be wrong. It turns out that the government’s handling of real fish -specifically, catfish – dwarfs that million-dollar monstrosity.

A special interest provision tacked onto the 2008 Farm Bill mandated that the USDA inspect all imported catfish.  Proponents, who unsurprisingly included those with a stake in the American catfish industry, cited safety concerns as the reason behind the program, patriotically claiming that protecting Americans from bad foreign catfish was as important, if notmore important than protecting them from foreign terror groups.

Unfortunately, their argument for a sort of “catfish TSA” doesn’t hold water. As it turns out, all catfish are already inspected by the FDA, so this second inspection would be superfluous at best and at worst, a complete waste of taxpayer funds. Second, catfish are actually low on the threat-level scale, labeled a “low-risk” food by both the CDC and – get this – the USDA itself.

You read that right.

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Capitol Confidential

Will Doctors or Bureaucrats Prescribe Our Health Care?

by Capitol Confidential

Senator Jon Kyl and a group of Senators – including Sens. Mitch McConnell (Ky.), John Barrasso (R-Wyo.), Tom Coburn (R-Okla.), Mike Crapo (R-Idaho), and Pat Roberts (R-Kan.) have introduced critical legislation that seeks to protect the doctor and patient relationship from the oncoming onslaught of ObamaCare.

Known as the PATIENTS Act, the bill works to protect the individualized relationship between doctors and patients ensuring that new government rules and mandates that put a premium on cost never interfere with the practice of quality medicine.

To better understand how that will happen if ObamaCare is not defunded or repealed, it is critical to understand the nature of “comparative effectiveness research.” In order to save money for the cost of socialist health care regimes, bureaucrats often play the “comparative effectiveness research” card to mandate that doctors provide inferior care and treatment that often does not work.

These studies, for which there is nearly a billion dollars worth of funding in the ObamaCare bill, become the basis of bureaucratic mandates that substitute the government’s judgment for that of a doctor. For instance, if a government study says that drug X is as effective as drug Y (which is cheaper), the government will often begin to deny coverage for drug X forcing the doctor to use drug Y. In some instances, patients only respond to drug X. Doctors and patients should never be forced to take drugs that don’t work. Doctor’s need to be able to make these decisions without interference from a bureaucrat. That is what the Kyl bill seeks.

This is not a theoretical argument any longer.

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Tom Fitton

Judicial Watch Obtains Documents Detailing ObamaCare Rationing

by Tom Fitton

The Centers for Medicaid and Medicare (CMS), under enormous public pressure, proposed that Provenge, a Food and Drug Administration (FDA) approved treatment for prostate cancer, be covered by insurance following a controversial “review.” A final decision on the issue is expected to be published 60 days after the public comment period for the proposed decision has ended.

On the same day as the CMS decision, Judicial Watch released hundreds of pages of documents from the Obama Department of Health and Human Services (HHS) detailing how and why the review was instituted. And here’s one of our major finds: While the Obama administration claimed the cost of Provenge had nothing to do with their review, these documents suggest otherwise. (Remember Medicare and the FDA are legally prohibited from denying approval of a medical treatment based solely on cost.)

Judicial Watch filed a FOIA request with HHS over Provenge after the press reported the CMS had taken the rare step of calling for a review Provenge to see if it is “reasonable and necessary” and should be covered by Medicaid and Medicare.

The move caused widespread panic among those patients who depend on the treatments to live, as well as anyone else who had heard all about health care rationing and “death panels” under Obamacare. (Let’s not forget, Obama named “Death Panel Donald” Berwick to head CMS and Berwick is on record supporting the idea of health care rationing, so these fears are not unfounded.)

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Capitol Confidential

Preserving Patient and Doctor Choice

by Capitol Confidential

Senator Jon Kyl (R-AZ) has introduced critical legislation that aims to stem the coming tide of rationing of America’s health care services. The PATIENT’s Act will ensure doctors and patients have the final say about medical treatment and new ObamaCare created “comparative effectiveness research” will not put a government created barrier to better treatment.

On the surface, there is nothing inherently wrong with “comparative effectiveness research.” Advocates believe it will save the taxpayers money by studying whether alternative and cheaper treatments are just as effective as currently prescribed methods of treatment. ObamaCare appropriated nearly $1 billion for such studies.

The problem, however, is when government takes that research and mandates a “one-size-fits-all” health care regimen that does not fit every patient . And with government mandated to reduce the cost of health care, these studies will assuredly become the intellectual justification of rationing. Here’s why.

Doctors have a unique relationship with their patients. They know how they respond to treatments. Government bureaucrats do not know, and frankly do not care, how an individual responds. They care about the big picture – the bottom line. If they can show cost savings by swapping a drug, they will do it. That appears to be happening with the drugs Lucentis and Avastin.

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Smart Girl Politics

Beware the Nanny State, It’s Coming For Your Soap

by Smart Girl Politics

Americans are living longer than ever due in large part to advancements in science, but you wouldn’t know it from listening to the wailing and gnashing of teeth by environmental extremists. It seems that every day brings news of some substance that will maim, injure or bring about Armageddon. The latest target of these extremists is the antibacterial agent Triclosan, a substance used safely and effectively for decades by millions of Americans.

Triclosan is found in soap, toothpaste, trash bags, toys, and hundreds of other products used daily by consumers. Although there is little-to-no data to back them up, an alliance of junk science organizations is petitioning the EPA to ban the use of Triclosan. Of course, when has the absence of facts ever stopped the left?

[On a side note, a quick trip around the web shows that the groups involved in this petition are serial petitioners and instigators of baseless lawsuits. And they are rewarded quite handsomely for their efforts, oftentimes by the very same corporations they claim to abhor.]

Here’s what we do know about Triclosan:

It is important that this issue be framed correctly. This is not a debate about the effectiveness of antibacterial products, but it is a debate about choice.

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Capitol Confidential

ObamaCare: The Road to Rationing

by Capitol Confidential

It doesn’t take a soothsayer to know that if ObamaCare and the push toward government-run health care continue, America will begin to ration drugs and treatment for the sick and the elderly.

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.

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Reason TV

Who Wants to Live Forever? Dr. Stephen Coles on the Secrets of the World’s Oldest People

by Reason TV

UCLA’s Dr. Stephen Coles studies the oldest people in the world. Hitting the century mark isn’t enough to pique his interest because Coles’ research focuses on supercentenarians, that is, those at least 110-year-old. Today Coles recognizes only 88 people worldwide as supercententarians, and the list is available at the Gerontology Research Group website.

Dr. Coles sat down with Reason.tv’s Ted Balaker to explain why supercententarians live so long, what eventually does them in (it’s not old age), and what could be done to help them (and the rest of us) live longer lives.

Topics include: FDA regulations, the Singularity, and immortality.

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Capitol Confidential

Reps. Granger and Nunnelee Call Out Healthcare Bureaucrats on Rationing

by Capitol Confidential

As breast cancer patients anxiously await a June Food and Drug Administration (FDA) hearing to determine whether they will continue to have access to the life-saving drug Avastin, members of Congress are standing up for patients. Most notably Sen. David Vitter in the Senate and Rep. Kay Granger in the House, and now Rep. Alan Nunnelee, have recognized the dangerous precedent of the Avastin case. Including costs in the evaluation process will limit access of drugs to patients, interfere with the doctor/patient relationship and start American down the road to rationing.

Avastin is an (expensive) anti-cancer drug that has been proven to extend the life of patients. Some unfortunately do not see great gains – perhaps only a few months – while others live for years, crediting the drug for their survival. The FDA is attempting to “de-label” the drug, meaning the drug would be available if you could afford to pay for the drug out of your own pocket. Insurance and Medicare would no longer assist patients in paying for the drug.

At a House Appropriations Subcommittee hearing, Granger raised her concerns about the pending Avastin decision directly to the Secretary of Health and Human Services, Kathleen Sebelius. Granger pointed out that patients and doctors in her district have alerted her to the decision and believe having the Avastin option is a critical tool in fighting breast cancer. Granger pressed Sebelius to assure seniors that Medicare would continue to allow doctors the choice of prescribing Avastin and cover its costs. Sebelius could not or would not. Should the FDA move forward, cancer patients will be on their own – the first victims of the effort to “bend the health care cost curve.”

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