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Archive for November, 2007

Psych Drugs, Shady Practices and One Fixer

In 2003, after taking Zoloft for six weeks to help him sleep, Woody Witczak, a vivacious, intelligent, energetic and happy man, hung himself — and died.

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Last evening I leafed through my December issue of Consumer Reports. There on page 65 was my friend and colleague Kim Witczak, Woody’s widow, and one of the most active fixers I know.

The article featured Kim’s work to clean up the rules by which drugs get approved by the FDA. Since Woody took his own life, and because it seemed so completely outside anything Woody ever would have done, Kim knew there must be some kind of dark force, some kind of shady coverup that contributed to the tragedy.

She learned several things. She learned that Zoloft is an antidepressant, not a sleep aid, and it had been prescribed to Woody “off-label.” Woody had just begun working at his dream job. His sleeping problems were related to his excitement and overwork — not depression problems. Kim questioned how Zoloft could have been prescribed for him.

Digging further, she learned a few things about Zoloft and even more about the FDA and its approval process for new drugs. Included were the following: pharmaceutical manufacturers could apply for approval to make drugs available to patients by showcasing only those clinical trials that show the drugs “work.” They were able to cover up any others that didn’t work out so favorably. Also, once a drug was approved, the FDA could request follow up studies, but had no way of enforcing those requests.

It also turns out that among the people who have the power to approve or disapprove any given drug, are people who may benefit financially from the sale of the drug. Think about that for a moment…. A panel of professionals is supposed to objectively determine whether a pharma company can make millions or billions of dollars on a drug — and some of those people will be the ones who make money when it’s sold.

Objective? I think not.

And here’s a big one, too — more than half the FDA’s budget for considering whether or not drugs should be approved comes from the fees paid to them by the pharma companies. So, when paired with the revelation above about who sits on the review panels?

Scary, isn’t it?

In September, the laws changed for how drugs will get approved, and what follow up will be required. The law goes into effect within 18 months. Kim was a large force in getting the changes made, as was Consumer’s Union, the publisher of Consumer Reports.

The changes affected were: All clinical trials used to prove a drug is — or isn’t — safe will be made public. There will be some new regulations on the drug ads we see. All print ads will have a toll free number and a web address to help consumers report problems. The numbers of reviewers on the approval panel with ties to drug companies will be reduced (but not eliminated). But no change has been made to how the FDA’s budget is put together — meaning — approvals will continue to be influenced by contributions made by the pharma companies seeking those approvals.

There’s not much of a message here for us as individual patients and consumers — except — to be thankful we have people like Kim Witczak who take their pain and suffering from the loss of a loved one and turn it away from blaming and into fixing. You can learn more at Kim’s website, WoodyMatters.org .

Healthcare will be safer because of Kim’s work, and that of Consumer’s Union, too. Fixers at their finest.

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MRSA: Those With Power Aren’t Paying Attention

Two reminders during the past week about MRSA and the real problems facing those who are infected by it — and those who aren’t.

The first was an email from Genevieve who told me about her husband’s experience after knee replacement surgery. Two days after being removed to a rehab center, he began running a fever, and his incision starting turning red — obviously the sign of an infection.

He was transported by ambulance to the hospital where he had the surgery, and the resident on call proceeded to examine his knee — with no gloves on! Genevieve objected — loudly she says — “wait! what if it’s MRSA?”

The doctor turned to her and in a loud voice, exclaimed that MRSA wasn’t the problem everyone thinks it is, and she shouldn’t get so upset! Genevieve, however, insisted he wash his hands and put on gloves before touching her husband again. (you, go, Genevieve!) Fortunately, while there was in infection at the site of the surgery, it was not MRSA.

The second reminder came in the form of an editorial included in Health Leader’s Media by Molly Rowe called MRSA, MRSA Me. She tells about her difficulties this past summer in getting her “spider bites” diagnosed as the MRSA they were, and the ensuing disinterest on the part of her family care doctor when she was later scheduled for knee surgery and they didn’t care about double checking that her infection had, in fact, been healed. You can just imagine what might have happened had the MRSA spread to her surgical site.

Clearly, despite the media attention, despite the 100,000 deaths each year, despite the cost to hospitals of taking care of those who get sick from it — the very people who can make a difference don’t seem to be paying attention! It’s as if they take the concept of transparency (recognizing the problem so they can do something about it) to mean invisibility (if we ignore it, it will go away.)

It’s time those leaders in hospitals, and their staff, became “infected” with whatever impetus is needed to take note and take these infections seriously. Sadly, it will likely require some horrible tragedy — like the loss of a hospital’s CEO or the CEO’s loved one to MRSA — before the people in a position to make a difference will do so.

For now, we patients need to do just what Genevieve did. She proclaimed her dissatisfaction loudly to take care of the present danger. THEN, she got in touch with the hospital’s administration afterwards to complain. She is truly an empowered advocate.

  ………………
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  ………………

MRSA: Those With Power Aren’t Paying Attention

Two reminders during the past week about MRSA and the real problems facing those who are infected by it — and those who aren’t.

The first was an email from Genevieve who told me about her husband’s experience after knee replacement surgery. Two days after being removed to a rehab center, he began running a fever, and his incision starting turning red — obviously the sign of an infection.

He was transported by ambulance to the hospital where he had the surgery, and the resident on call proceeded to examine his knee — with no gloves on! Genevieve objected — loudly she says — “wait! what if it’s MRSA?”

The doctor turned to her and in a loud voice, exclaimed that MRSA wasn’t the problem everyone thinks it is, and she shouldn’t get so upset! Genevieve, however, insisted he wash his hands and put on gloves before touching her husband again. (you, go, Genevieve!) Fortunately, while there was in infection at the site of the surgery, it was not MRSA.

The second reminder came in the form of an editorial included in Health Leader’s Media by Molly Rowe called MRSA, MRSA Me. She tells about her difficulties this past summer in getting her “spider bites” diagnosed as the MRSA they were, and the ensuing disinterest on the part of her family care doctor when she was later scheduled for knee surgery and they didn’t care about double checking that her infection had, in fact, been healed. You can just imagine what might have happened had the MRSA spread to her surgical site.

Clearly, despite the media attention, despite the 100,000 deaths each year, despite the cost to hospitals of taking care of those who get sick from it — the very people who can make a difference don’t seem to be paying attention! It’s as if they take the concept of transparency (recognizing the problem so they can do something about it) to mean invisibility (if we ignore it, it will go away.)

It’s time those leaders in hospitals, and their staff, became “infected” with whatever impetus is needed to take note and take these infections seriously. Sadly, it will likely require some horrible tragedy — like the loss of a hospital’s CEO or the CEO’s loved one to MRSA — before the people in a position to make a difference will do so.

For now, we patients need to do just what Genevieve did. She proclaimed her dissatisfaction loudly to take care of the present danger. THEN, she got in touch with the hospital’s administration afterwards to complain. She is truly an empowered advocate.

  ………………
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  ………………

Kickbacks: Doctors, Pharma, Insurance and Surprise! Patients Caught in the Middle

See if you can get your arms around the following conundrum, which is typical of our dysfunctional American Healthcare System — only this time with a twist. We’ll begin with point-of-view:

Consumers (that’s us patients!): When we need a prescription drug to improve our health, we want the best drug for what ails us, at the lowest price possible. We also want affordable health insurance, with fair co-pays for those drugs.

Physicians: When it comes time to prescribing a drug for a patient, the doctor wants to be sure it’s the right drug with the best chance of improving the patient’s health. Further, the physician is also on the constant lookout for ways to increase his/her income. They are offered money, support and/or other incentives from pharma manufacturers on a constant basis, but this practice has become a real point of contention because it creates a conflict of interest. Now, for many, a possible new income stream has been offered by insurance companies (see below.)

Pharma companies: Are interested in maximizing income. Period. And they will do whatever they can to protect that interest. Their real allegiance is to their stockholders who may also be any of the players mentioned here. The great majority of their income is derived from branded/innovator drugs and they take a huge hit when their patents run out and they begin to compete against generics. They look for ways to reward doctors for prescribing and using their drugs.

Insurance companies: Are interested in maximizing income. Period. And they will do whatever they can to protect that interest. Even the not-for-profits want to maximize their income so they can pay out bigger bonuses to their top people. They are constantly on the lookout for ways to reduce their costs so their profits are larger. When they can get doctors to switch patients to generic drugs, (or when they can get patients to ask their doctors about the possibility) then they can save costs.

Some background:

Section 1128B(b) of the Social Security Act (42 U.S.C. 1320a-7b(b)) (gotta love those citations) is a federal law called the anti-kickback statute. The statute states that violations of this law are punishable by up to five years in prison, criminal fines of up to $25,000, civil monetary penalties up to $50,000, and exclusion from participation in federal health care programs like Medicare.

So here’s the situation:

It seems that earlier this year, Blue Cross/Blue Shield of Michigan began paying doctors $100 for each patient they switched from Lipitor, a branded/innovator drug to its generic equivalent. In other states, like Massachusetts, doctors receive a financial reward at the end of the year for making branded-to-generic switches to qualify.

Now these doctors are being told that, from the point of view of the federal government, they are violating the anti-kickback statute and could be fined and banned from working with the programs like Medicare that often become their bread and butter.

And here’s the conundrum:

As usual, patients are caught in the middle. Let’s return to our patient point of view. We want the best drug at the best price. The best drug may be the innovator drug OR it may be the generic — since they are bio-equivalent, then they are presumably the same. But the cost is not the same — the cost of the generic may be far less — even hundreds or thousands of dollars less in the course of a year. So often, the “better” drug for us is the generic.

Now, doctors in the states where insurance companies are offering the kickbacks are caught in the middle — should they switch their patients to generic drugs, which is better for the insurance companies, and may be better for their wallets, too? Or should they continue to prescribe the innovator drug, which is more costly, but may reap benefits provided to them by pharma companies, too?

Clearly, now, there is a law with some teeth against kickbacks — but why is only one of these scenarios considered a kickback?

And once more from the patient’s point of view — when the doctor prescribes a drug for us — should we be asking whether the doctor benefits one way or the other? We know now that even the American Medical Association has developed a policy against insurance company control of which drug is prescribed. That’s as it should be.

But I’ll ask the question again – why should payments from an insurance company be considered a kickback, but support from the pharma companies not be considered the same thing?

And why should either the insurance company OR the pharma company be dictating which drug is prescribed for us, which is what they do when they offer incentives to the physician? With no incentives, then the recommendation will be made more objectively.

So there’s your conundrum for today — with a twist. What do you think?

Begin with this statement: “when patients step up to take charge of their own medical decision-making….”

(And don’t forget — we don’t have to be victims!)

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From the Desk of (11/24/07)…

Some miscellany from the week, not requiring blog posts on their own….fromthedeskof.gif

Hope you all had a delightful Thanksgiving and that your leftovers are no longer left over.

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Another quiet week with the arrival of the holiday. I did hear from some folks I’ve not heard from in awhile, with atta-girls for my mention in the Wall Street Journal article this week. Among them, Dr. Allan Showalter who runs a very comprehensive and thought provoking website and blog about medical compliance. He says he’s looking forward to when I finally appear on the cover of Rolling Stone. (hey! me too! isn’t that every boomer’s fantasy? !!) Thanks, my Ozark-bound friend.

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Looks like Dr. Scott Haig has really riled some feathers — both patient-side and physician-side — with his Time/CNN articles about patients who google. Included is my soon-to-be About.com colleague (there’s a hint!) Mary Shoman whose blog was even cited in the New York Times. I posted about the article a week or so ago, and Mary and I see his post differently — but there are a couple of bottom lines to the question. The first one is that if we are to communicate well — patients and doctors — then we need to be able to understand the other’s point of view. And second, that I still believe Dr. Haig misdiagnosed himself. In fact, I don’t think it was so much the fact that his patient had used google to get information about her knee problem; instead, I think she was just obnoxious and honestly, I don’t blame him for not wanting to treat an obnoxious patient.

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My big news? Still on hold for the moment…. fully expect to announce it this week…. and I did give a hint above :-)

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