- - Tuesday, June 21, 2011

In 2009, our bureaucratic ruling class suddenly declared that women in their 40s no longer needed mammography screening. This came as a shock to me and to the 20 percent of my breast cancer patients who are women in their 40s. They were livid, as were their families and millions like them across America, and they proceeded to melt Washington’s phone lines to express their outrage. This will pale in comparison to the fury of women’s scorn if Richard Pazdur, the Food and Drug Administration’s (FDA) cancer czar, gets his way.

An anti-cancer drug called Avastin is no silver bullet but it is an innovative treatment that targets the blood supply of tumors. Nothing yet will cure metastatic breast cancer, but Avastin has been shown to extend women’s lives. It’s now a matter of how long and how much it costs. It’s not a cure but it’s a chance for more time - hope for a final Christmas or to see a son’s wedding or the birth of a granddaughter.

Bureaucrats at the FDA are like the stereotypical aging athlete constantly reliving his high school glory days. To justify its existence, the FDA fondly points back a full five decades to “everybody’s favorite example”: Thalidomide. American kids were spared the heart-breaking birth defects suffered by Europeans because of the FDA’s slow, more deliberate drug approval process. The FDA trumpets from the rooftops these thousands of Thalidomide lives spared a half-century ago but they become deafeningly silent about the millions of lives still being lost to this day by their foot-dragging.

Prior to rule changes in 1962, average approval time for new medicines in America was seven months - well ahead of Europe. By the 1990s, America had lost its edge and approval time was stretched out to more than seven years.

The FDA, stuck in its 1960s Thalidomide glory days mindset, denies Americans access to life-saving drugs. Take, for example, the so-called statin class of cholesterol-lowering drugs that you know today as Lipitor, Crestor, Zocor and many others. In 1978, Merck developed their first statin drug but it wasn’t until nine years later that the FDA finally allowed Americans to benefit from it. Meanwhile, millions of heart attack and stroke deaths occurred and many would have been prevented. The same story is true for countless other drugs and diseases.

In the 1980s, HIV/AIDS activists heroically and successfully lobbied Congress to create an accelerated approval process particularly for terminal patients who had little to lose but everything to gain from new drugs. It worked and today, HIV treatment continues to be an American success story. The FDA’s cancer czar has thumbed his nose at Congress by effectively and nearly single-handedly eliminating the accelerated approval process they created.

Genentech, the creator of the anti-cancer drug Avastin, successfully met all of the FDA’s own fast-track requirements only to find that Dr. Pazdur’s hand-picked team retroactively moved the goalposts to block the drug anyway. More than 17,000 metastatic breast cancer patients who are currently taking Avastin have become Dr. Pazdur’s pawns. Sadly, these women know they won’t be cured, but many have seen their cancers go into remission for months and some for years because of this drug.

The FDA, despite its intentions, drives up the costs of medicines and often dries up the supply chain altogether. America is currently facing a shortage of about 246 drugs - a record high. This doesn’t happen by accident. Consider the alarming conclusions reached, not by the supposedly evil pharmaceutical companies, but by physicians and pharmacists at last year’s Drug Shortages Summit.

A joint report by the American Society of Anesthesiologists, the American Society of Oncology, the American Society of Health-System Pharmacists and the Institute for Safe Medication Practices sounded the alarm: “Several drug shortages have been precipitated by actual or anticipated action by the FDA.” They note that the “cost and complexity” of the FDA’s “regulatory barriers” to providing new and even existing medicines is a “disincentive” to suppliers. Additionally, the “lengthy and unpredictable” approval process limits manufacturer’s ability to develop reliable production schedules.

The Obama doctrine to keep the government’s “boot on the neck” of private-sector companies is not just limited to Big Oil. A nanny state that won’t trust you to choose your own light bulbs certainly won’t approve of even a life-saving medication until every bureaucrat has had his say in triplicate. Americans have landed on the moon and mapped the human genome and yet we suffer from the self-imposed scientific stagnation created by the FDA.

It’s time for Congress to stand with American patients and wrest back control from this arrogant Food and Drug Administration but there is something you can do as well. The FDA’s anti-Avastin crowd is holding a public meeting this week in Washington and you can attend. If you can’t, this FDA death panel has names and phone numbers and email addresses. Visit my website (miltonwolf.com) or the Freedom to Access for Medicines website (fameds.org) for information and make your (polite and patriotic) voice heard. Seventeen thousand women hope you’ll speak up for them.

Dr. Milton R. Wolf, a Washington Times columnist, is a board-certified diagnostic radiologist and President Obama’s cousin.