Wednesday, March 25, 2009

Health-Care Reform Smackdowns!

To paraphrase President Obama, fixing our busted health care system isn’t going to be easy. Or quick. But in a twisted kind of way, it can be entertaining to watch. Sort of like professional wrestling. Or watching a NASCAR race for the crashes.

All signs point to the FDA as the first major casualty, and it can’t come soon enough for me. This poor excuse for a government agency (amid all other poor excuses for government agencies) looks like it’s going to be ripped in two. Because it can neither keep our food supply safe nor test and approve drugs adequately and in a timely fashion, the chorus is growing to create two agencies – one that handles our food supply and one that deals with medical products.

On the food side, the Tainted Peanut Butter Debacle pretty much sealed the deal for any kind of credibility the FDA may have over our food safety. It didn’t help that it came on the heels of contaminated spinach, lettuce, jalapenos, pet food and infant formulas.

And in their medical division, case after case keeps rolling in about corruption, either by pharmaceutical companies that did not perform adequate testing of their products or buried their bad press; or by researchers who planted glowing - albeit forged - studies in medical journals so they wouldn’t lose their funding. I’ve lost count of how many pharmaceutical companies are being sued in class-action suits about poorly studied medications that either caused deaths or serious injury.

For instance, the diabetes drug Avandia has been shown to increase people’s risks for heart attacks. Apparently, GlaxoSmithKline, the pharmaceutical company that makes the drug, knew about this for years before actually getting around to telling us. (Oops.) And several years ago, the FDA buckled under pressure from Congress to get Merck to pull its painkiller, Vioxx, from the market also for causing number of heart attacks among its users.

The FDA’s continual refrain is that they are understaffed and under-funded. But the food side is continually getting short shrift. According the Institute of Medicine, this year the FDA will spend $.73 on food safety for every dollar it spends on drugs. One expert said that an agency that [theoretically] assures the safety of complex, $3000-a-month biotech drugs should not also have to regulate $3 jars of peanut butter. But in straining to do both tasks, they have done neither very well.

Donald Trump would have fired them a long time ago.

So Barack Obama raised hopes of an agency divorce when he placed two public health specialists at the head of the agency and appointed an advisory group to study our ancient food safety laws.

If she were to be confirmed, Margaret Hamburg, former NYC Health Commissioner, would be the FDA commissioner. For her deputy, she has chosen Joshua Sharfstein, a prominent pediatrician and outspoken critic of children’s cold medicines.

According to an interview by the Associated Press, this combination of appointees prompted Peter Pitts, a former FDA official, to speculate that Hamburg would run the food safety division of the FDA and that Sharfstein would move over to run the medical side of the street.

Big Pharma executives couldn’t be more pleased at this possibility. They believe that peeling the medical division off from the FDA could speed up lagging drug approvals, which have become bogged down because of all of that pesky food safety stuff. They also believe that public outcry over food contamination (I know – what nerve we have to expect untainted food!) have made FDA officials even more hinky about drug approvals.

But pharmaceutical advocates are keeping their happy dances to themselves. “Every CEO that I know in health care is in favor of this, but none that value their share prices will go on the record for fear of retribution from the FDA,” said Steve Brozak, president of WPB securities, an investment brokerage focused on drug and biotech companies.

Other than to say that “the status quo is unacceptable,” pharmaceutical lobbyists would not comment on the possibility of a new drug agency. The FDA itself is keeping mum as well.

If the agency has irreconcilable differences and a divorce is granted, look for a big fight on Capitol Hill. It would mean our rejiggering of committees, which means power shifts and people who will not be so willing to give up their power. This should be good.

Of course, splitting the two agencies could backfire. Instead of one bogged down, under-funded and understaffed agencies, we could have two bogged down, under-funded and understaffed agencies.

But I hope not.

Next up on Saturday Night Wrestling is actually more of a stealth battle between the health-insurance industry and Congress.

And somebody has been reading Sun Tzu’s “The Art of War.”

The health insurance industry made the opening gambit by appearing to offer a concession: they are willing to give up the practice of charging higher premiums for people with pre-existing conditions. But wait. This is not exactly a concession if you think about it. If Congress wants to run its own insurance plan, they would put themselves in competition with the health insurance agency. So why wouldn’t companies like Blue Cross want to make themselves look more attractive to consumers by looking like good guys for not charging your mother higher premiums because she has diabetes?

Congress? It’s your move.

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