Health Reform Hub Issues

Issues :: Pharmaceutical

The Avastin Mugging
Wall Street Journal Op-ed, 8/18/10

If there's an American precedent for the medical central planning of ObamaCare, it's the Food and Drug Administration. Witness a looming FDA ruling that may deplete the drug arsenal for terminally ill cancer patients. Last month, an FDA advisory board recommended withdrawing government approval of Avastin as a treatment for advanced breast cancer. The decision betrays a bias that puts costs above treatment, and unless the FDA leadership overrules its own experts, the 40,000 women killed by breast cancer each year will be denied an important clinical option. Read more...

Free to Choose Medicine
Millions of people suffer needlessly every year from painful medical conditions and thousands die prematurely even though there are drugs that could help them. Free To Choose Medicine, by Bartley J. Madden, looks at why this tragedy occurs and what can be
done to end it. Order this book published by the Heartland Institute.

Avastin Shouldn't Make the FDA Give Up on 'Accelerated Approval' of Drugs
Henry I. Miller and Jeff Stier

Los Angeles Times, 8/17/10

An important but obscure aspect of the Food and Drug Administration's regulation of drugs has been in the news in recent months. Called "accelerated approval," this "quick-on, quick-off" mechanism for medicines to reach the marketplace can work to the advantage of drug companies and needy patients alike. Introduced almost two decades ago, accelerated approval permits the FDA to issue what amounts to a limited, or conditional, approval of a new drug that is intended for a "serious or life-threatening disease" and for which there is an "unmet medical need." Read more...

Opinion: Fail First? Is This Any Way to Practice Medicine?
David Charles, M.D.

AOL News, 8/16/10

Louisiana has become the most recent state to take action against a little understood abuse of the health care system that has been causing unnecessary suffering for patients for far too long. Recently, Gov. Bobby Jindal signed a new law protecting patients from the "fail first" approach to prescribing drugs. This is an approach widely used by health insurance carriers and pharmacy benefits managers that forces patients to go without the drug their doctor has prescribed and use a cheaper drug. If the less costly alternative drug fails to help the patient, the next step required by the insurance carrier is usually another substitute drug, always a cheaper one than the drug prescribed by the patient's doctor. After failing to get results with two substitute drugs, the third step might be approval of the drug originally prescribed. Read more...

US Breast Cancer Drug Decision 'Marks Start of Death Panels'
Nick Allen, in Los Angeles and Andrew Hough

The Daily Telegraph, 8/16/10

America's health watchdog is considering revoking its approval of the drug Avastin for use on women with advanced breast cancer, leading to accusations that it will mark the start of 'death panel' drug rationing. A decision to rescind endorsement of the drug would reignite the highly charged debate over US health care reform and how much the state should spend on new and expensive treatments. Avastin, the world’s best selling cancer drug, is primarily used to treat colon cancer and was approved by the US Food and Drug Administration in 2008 for use on women with breast cancer that has spread. ... The FDA advisory panel has now voted 12-1 to drop the endorsement for breast cancer treatment. The panel unusually cited "effectiveness" grounds for the decision. But it has been claimed that "cost effectiveness" was the real reason ahead of reforms in which the government will extend health insurance to the poorest. Read more...

Move Over Mom, Here Comes ObamaCare
Ron Bachman

The Daily Caller, 8/16/10

For years, consumers have been encouraged to use lower cost generics and even less expensive OTC medications. ... Many use a plan-provided debit card to pay for medications. As part of their insurance plans, families can use these accounts to purchase OTC medications such as prenatal vitamins, antacids, allergy medicines, pain relievers, and cold medicines. So, what changes under ObamaCare? Read for yourself. Section 9003 of ObamaCare states: “A drug is a prescribed drug determined without regard to whether such drug is available without a prescription.” What??? Translation from government-speak: Effective January 1, 2011, an OTC medication needs a doctor’s prescription to be defined as a qualified medical expense, even if it is otherwise available without a prescription! Only in the world of government control and bureaucracy would it make sense to require a mom, who is treating a sick child at 3am, to get a prescription for an OTC medication. That trip to the 24-hour pharmacy just got “government complicated.” Read more...

Where Did All the Vaccines Go?
Grace-Marie Turner

The Orange County Register, 8/12/10

The California Department of Health recently categorized a local outbreak of whooping cough as an epidemic. Seven newborns have already died from the disease. And the total number of California whooping-cough cases is six times what it was last year, with more than 2,000 illnesses confirmed thus far in 2010. Authorities are urging Californians of all ages to get vaccinated. America is hardly safe from the threat of epidemics. Each week, hundreds of vaccine-preventable illnesses are reported to the Centers for Disease Control. Decades of poor policymaking have radically reduced our country's ability to make and develop vaccines. We all have good reason to worry about future outbreaks. Read more...

 Making the World Safe for Rx.com
Roger Bate

The American, 8/12/10

Buying foreign-made drugs over the Internet from foreign Web pharmacies can be relatively safe. A recent survey from Pew Trusts shows that Americans are worried about foreign-made drugs. Notably, 70 percent were worried about Chinese products and 54 percent were worried about Indian products. Senator Michael Bennet (D-Colorado) has introduced legislation that he believes will improve safety. “In 2009, there were a record 1,742 drug recalls—a 400 percent increase from the prior year, and the vast majority were related to manufacturing quality and testing,” Senator Bennet recently said. “Ensuring quality is made more difficult by the globalization of drug manufacturing. Up to 80 percent of the active ingredients in U.S. drugs are now made overseas, many in countries where regulatory oversight does not meet U.S. standards.” Read more...

Leviathan's Drug Problem
John R. Graham

Pacific Research Institute, 07/27/10



This study concludes that allowing American patients to access medicines that have already been approved in Europe would increase regulatory competition, enable more patient choice, and potentially save the lives of those suffering life-threatening illnesses and who currently have no treatment options. Read more...

Lilly CEO sizes up challenges, lessons learned
Kathy Chu

USA Today/Indianapolis Star, 07/21/10

...Here's what John Lechleiter, CEO of Indianapolis-based pharmaceutical giant Eli Lilly and Co., had to say about some of those challenges in a recent interview with USA Today. Read more...