July 17, 2007
It's Pharma's World, You Just Live In It
A new study finds that older, cheaper diabetes drugs control blood sugar as well, with somewhat less harmful side effects, than newer, more expensive ones. In a sane health care system, this would mean a rush to prescribe these older agents, or at least to gather more data on the subject. In our health care system, where doctors take tens of thousands from pharmaceutical companies and patients are bombarded with advertising to make them think they want, or know they want, certain drugs, the more expensive, no more effective, compounds will almost certainly remain atop the market. There's simply no incentive for doctors to switch over, but plenty of incentive for them to prescribe the more costly drugs.
And if that doesn't work, maybe the drug industry will just take a page from their playbook for the epileptic drugs that are about to lose patent and go generic, and try and get state legislatures to pass laws making it illegal for pharmacists to switch patients over to cheaper, perfectly effective generic alternatives. Illegal. But that's no surprise: Pharma spent $44 million on statehouse lobbying in 2005 and 2006 -- and they weren't just buying good times. Hell, in this case, they donated tons of money to the Epilepsy Foundation and did the lobbying under their auspices.
But look, Andrew Sullivan tells me the pharmaceutical industry is great, and way better than in Europe, so I'm sure this is all some sort of big misunderstanding. If they don't keep patients from switching to generics, after all, how will they fund R&D!?
There's simply no incentive for doctors to switch over, but plenty of incentive for them to prescribe the more costly drugs.
Let's be real clear. Single-payer does not change this. What does changes this is greater emphasis on reasonable cost-sharing with patients, i.e. more focus on consumers directing their care.
No real benefit to new diabetes drugs? Then the costs to consumers should be passed on accordingly for these drugs.
Posted by: wisewon | Jul 17, 2007 10:43:32 AM
In our health care system, where doctors take tens of thousands from pharmaceutical companies and patients are bombarded with advertising to make them think they want, or know they want, certain drugs, the more expensive, no more effective, compounds will almost certainly remain atop the market. There's simply no incentive for doctors to switch over, but plenty of incentive for them to prescribe the more costly drugs.
Not necessarily; the incentive to go back to the older, cheaper drug rests with health plans and their formularies, which, I'd bet, will steer people towards the older drugs that have greater efficacy, and are cheaper. The problem with pharma's advertising and other marketing ("informational" brochures, etc) is that they will try to convince consumers that the newer stuff, by virtue of being new, is preferable. And some patients will wonder why their doctors steer them towards the older stuff. This goes back to two things about the healthcare debate - demonizing insurers and HMOs is easy, but in some ways they represent the perfectly sane approach to controlling costs when other actors are in favor of expensive and unnecessary treatments; and that one central thing that's largely ignored is the need to educate patients more fully on separating pharmaceutical claims from determining what's best about their health (and that, really, underlines the mistaken conservative approach to HSAs - the idea that patients make good self directed consumers is rather absurd).
Posted by: weboy | Jul 17, 2007 10:44:38 AM
How will they fund R&D? The old-fashioned way. They will buy more shares of Congress and really earn it through subsidized university/NIH research, more limits on imported drugs, and more restrictions on federal discount purchases - watch for them to try to limit VA's group discounts next. Oh, and more MD lunches/seminars in Fiji, and sampler give-aways by nicely dressed female account visits to the prescribers.
They have no shame. I have to practice daily saying corporations do not have a conscience (or a heart), since no red blood pumps through their veins to their heads. If cut, their fluid runs green.
Posted by: JimPortlandOR | Jul 17, 2007 10:51:14 AM
A purely factual point to clear up a likely misperception. Generics are not exact replicas of branded drugs. While they do contain the same exact active chemical, they do not have the same dissolution/absorption characteristics because they other ingredients in the pill are slightly different. As a result, generic drugs are allowed to vary up to 20% in actual physiologic absorption from the branded.
This is far from a defense of pharma re: the epilepsy strong-arm tactics. But from a pure clinical/scientific perspective, a change from branded to generics will lead some patients to have unnecessary seizures because of the differences described above. Whether we think the cost-savings justify it is a separate question.
Posted by: wisewon | Jul 17, 2007 10:57:02 AM
wiseone, this is much like the canard that that the solution is to set up HSA and manage risk that way-- I made a set of professional decisions to avoid being an insurance actuary. Similarly, I also chose not to go into medicine. What you're saying is that patients should be the ones analyzing drugs and protocols. I'd actually rather than doctors do that and that the pharm companies stop trying to influence physicians on anything other than the merits of the particular drugs. Consumer directed health care is a false premise because patients are not consumers, they are patients. It is deeply offensive and insulting to refer to some receiving medical treatment with the same term you refer to someone buying a car or a television.
Anecdotally, of course, there are cases where the generic creates adverse side-effects that are not present in the brand-name. Why this happens, I don't know-- but it shouldn't. Someone should look into that, because it's actually really wasteful and causes people trouble in certain cases.
Posted by: Tyro | Jul 17, 2007 11:07:20 AM
Wisewon, were is the wonderful power of regulation? You are quick to defend regulation as the panacea of our health care woes, but here you take it down as wrongheaded. The easy solution to this regulatory issues is to add that generics must vary in less than 10%, 5%, 1% than the branded drug. Of course a single payer plan could also insist that a generic be used when it is as effective as a brand drug and a government-run program could also stipulate that generics must adhere more closely to the clinical effects of the branded drug.
Posted by: Ricky | Jul 17, 2007 11:12:01 AM
What you're saying is that patients should be the ones analyzing drugs and protocols.
I am absolutely not saying this (and please don't lump me with the HSA folks, they oversimplified a complex issue to the point it was wrong.
What I am saying (and there is a whole thread on this based on a prior drug post), is that a differential in co-pays between equally effective generics and branded drugs should push consumers to ask their doctors whether the branded drug is really needed for them.
At the end of the day, the conversation that is sorely lacking in our health care system is one between patients and doctors discussing the benefits and financial costs of treatment options.
Posted by: wisewon | Jul 17, 2007 11:15:28 AM
The easy solution to this regulatory issues is to add that generics must vary in less than 10%, 5%, 1% than the branded drug.
A potential solution, but not necessarily easy. From a technical standpoint, the closer you make the generic profile requirements to branded, the more difficult it is to make, the less generics you have on market, the higher the price (in other words, you neeed typically need at least three of four generic manufacturers on market to get prices down to the levels we typically associate with generics. When its only one or two, they are typically priced at ~50-75% of branded) I don't know anyone who has looked at this issue, you are right that this could be a solution-- but you could also determine that the cost-impact of tightening generics requirements isn't worth the additional negative side effects associated with the 20% variance rule.
This would be a great issue for exploration by the FDA.
Posted by: wisewon | Jul 17, 2007 11:20:50 AM
“A new study finds that older, cheaper diabetes drugs control blood sugar as well, with somewhat less harmful side effects, than newer, more expensive ones. In a sane health care system, this would mean a rush to prescribe these older agents, or at least to gather more data on the subject.”
So how did they behave in some of the more sane systems of Europe?
“Consumer directed health care is a false premise because patients are not consumers, they are patients.’
Unless we as a society can get over this, healthcare will continue to be the bane of our policy existence. Not all patients are coming in on a gurney. This just isn’t the reality. My wife and I are going through a high risk pregnancy and we are equal partners with our doctor in this process. We do the research, we question our doctors and we act as smart consumers do. Why? We don’t care about cost b/c of insurance, but we do care about outcome and while we trust our doctors, we don’t blindly trust.
Without consumer involvement in the process, from both a cost management and decisioning perspective, we are doomed to continually overspending on healthcare.
Posted by: DM | Jul 17, 2007 11:25:30 AM
I dont see why this would initiate a rush to prescribe older agents since metformin, one of the older drugs featured in the study, is already the most prescribed oral drug for diabetes in the US.
Posted by: iron pimp hand | Jul 17, 2007 11:39:26 AM
is that a differential in co-pays between equally effective generics and branded drugs should push consumers to ask their doctors whether the branded drug is really needed for them.
My insurance plan does this, to the point where it's really a no-brainer if I'm prescribed something that already has a generic option-- I always go for the generic, and I have an excellent, excellent health insurance plan.
In the case where there is a choice between two different drugs -- one patented and one off-patent, the doctor should be the one to know which one is the best and prescribe that one, regardless of the patent issue involved. I don't know, because I'm not the one who makes diagnoses.
At the very least, any drug purchasing plans should always be on the lookout to see if pharm companies are promoting a drug that is just wasting everyone's money when generics are just as effective.
Part of this is my mindset-- I'm an expert in my own field, and I don't presume that my ability to analyze research in my own field translates to the ability to analyze clinical studies in pharmacology. To a certain degree, these sorts of large-scale evaluations of the benefits of these drugs is best done from the top town, rather than hoping that "the market" sorts out which patented drugs are better than the generics and which aren't.
Posted by: Tyro | Jul 17, 2007 11:52:34 AM
I always go for the generic, and I have an excellent, excellent health insurance plan.
You may, but generic SUBSTITUTION (i.e. same drug, not even changing to an equally effective but different drug) is only at around 70% in the US. The question here goes even beyond that, which is whether an old generic drug should be used over a new branded drug. In most situations, there is a minimally incremental benefit to the newer drug. From a purely clinical perspective, the newer one should be used. When the cost is factored in, the comparison is different. Doctors alone have woefully failed in the latter, and I think its extremely important that both doctor and patient are involved-- the cost-benefit tradeoff will be different for each patient.
Posted by: wisewon | Jul 17, 2007 12:00:51 PM
is that a differential in co-pays between equally effective generics and branded drugs should push consumers to ask their doctors whether the branded drug is really needed for them.
So which is it? Do we make decisions based upon price, or do we make decisions based upon important differences between branded and generic pharmaceuticals, since generics can differ from branded by up to 20%?
And who is it, exactly, that's supposed to know about all of this? And what does all of this have to do with making it illegal to prescribe generics?
If it's my responsibility to know and understand every aspect of every drug - branded and generic - that I'm prescribed, then why the hell do I need a prescription? I could just look up my symptoms on the internet, diagnose myself and go to the pharmacy and get the stuff I need off the shelf. That'd make medicine cheaper, if we don't need a cadre of $90,000/yr pharmacists handing this stuff out to us. And since we are all supposed to know everything about the drugs on the market, we don't need pharmacists.
I have read the full prescribing information on every drug I've been prescribed in the last 5 years. All. Of. It. And when I run across words I don't understand, I look them up. When I talk to my doctor about the medicines I take regularly, I'm more conversant - off the top of my head - about side effects and contraindications than she is. But I'm not a chemist, I'm not a pharmacist, I'm not a DO/MD. I didn't know except in a vague way that generics could differ from branded so much in dissoulution/absorbtion. The reason we pay these people is so they will know about this stuff. If my doctor is going to make $80 from me for each visit ($20 from me directly, $60 from insurance), then I expect a bit of return on that investment.
That's why this idea of consumer-directed healthcare is such a crock: it's making consumers do the work we're paying other people to do. And no matter how much reading and preparation the consumer does, he or she is still just a layperson and will necessarily not be able to make serious medical decisions on their own - whether they come in on a gurney or not.
DM, I'm sorry you guys are having a hard time with the pregnancy. Learning as much as you can is obviously the right thing to do. But if your doctor tells you something different than the ideas you came in with, who are you going to go with? If you come in convinced that a generic of a certain medicine is just fine and your doctor says differently, who will you believe? Or, what if there's a generic for a certain drug that your doctor does believe is just fine, but your state legislature has made illegal to prescribe?
When it comes down to it, us nanny-state liberals only want to make one big insurance pool. It's the pharmaceutical companies and insurance companies that are running to the government to protect their privileges and profits.
Posted by: Stephen | Jul 17, 2007 12:06:57 PM
The FDA is now a de facto partner of Big Pharma, and its scientists may find themselves muzzled when they raise concerns about a drug's efficacy and/or safety. Muzzled, or pressured to re-evaluate their findings, or pressured to resign. One such recent casualty was the FDA's Deputy director of the Division of Drug Risk Evaluation, Rosemary Johann-Liang, who raised questions about the diabetes drug Avandia:
She took her staff's advice and recommended in February 2006 that Avandia get a "black box" warning about congestive heart failure. For doing so, FDA staffers told Senate Finance Committee investigators, Johann-Liang was verbally reprimanded and told to talk to her director before making any major recommendations related to drug safety. [...]
Johann-Liang speaks of a convoluted system in which the FDA requires a higher level of proof of risk than of effectiveness.
The FDA approves diabetes drugs such as Avandia if clinical trials show they meet the "surrogate endpoint," or goal, of lowering blood sugar, she says, but then doesn't require makers to do follow-up studies of whether patients actually feel better and live longer.
Under FDA Commissioner Andrew C. Von Eschenbach, M.D., the agency is adopting a new business model (for lack of a better phrase) known as the Critical Path Initiative. According to Dr. Eschenbach, "To jump start this process, FDA has been working with the academic community, the public, the pharmaceutical industry, and other Federal health agencies...".
As you'd imagine, though, Big Pharma get the lion's share of face-time, as congressmen Maurice Hinchey (D-NY) and Bart Stupak (D-MI) noted in their June 11 press release:
The health and safety of the American people are at risk when drug industry representatives are the only individuals in the room advocating new drugs and keeping harmful drugs on the market.
Seventy-two FDA staff members participated in the 112 meetings with industry, combining for a total of 1,852.5 hours of meeting time, or 231.5 business days. Forty-nine representatives of the regulated industry met with the FDA, combining for 2,116 hours, or 264.5 business days. [...]
Despite consulting with industry representatives 112 times on PDUFA IV, the FDA apparently only had discussions with consumer and patient groups five times.
Anyone remember reading or hearing about that on any of the various television news programs? The ones whose primary demographic--if the heavy rotations of pill ads are any indication--must suffer disproportionately from erectile dysfunction, irritable bowel sydrome, and toenail fungus (not simultaneously, one hopes)?
Posted by: litbrit | Jul 17, 2007 12:10:55 PM
Ah, the power of the market at work. You really need the price of the generic drug, but you can't use it because it isn't effective. What the hell is anyone doing producing generic drugs that are supposed to do the same thing as the branded drug but don't? This is indeed another market failure in a business where failure is passed on to the customer as death or injury. Let's stop the BS that the market is what makes the health industry so good and recognize that the market is what makes the health industry so bad for the public it is supposed to be serving.
Posted by: ricky | Jul 17, 2007 12:14:47 PM
OT: At what point do these things become a gestalt that can't be argued away by nitpick analysis that is often wrong by the right?
Posted by: akaison | Jul 17, 2007 12:16:01 PM
Incidentally- re- the gestalt question. This conservation that people have with the right leaning commentators here reminds me of an Eddie Murphy joke. He talks about how his wife walks in to find him with another woman in bed. The wife is so overwhelmed and angry she just starts in on him. He calms her down and tells her he's not cheating on her. She proceeds to point to the woman in the bed. He says there is no woman in that bed. She says "what are you talking about she's right there." He says, "I love you. There's no woman in that bed." Finally, when he realizes he can't convince her there's no woman in the bed, and his wife keeps asking "how can you have sex with another woman." He says to her looking her dead in the eye, "I have sex with her, but I make love to you." This is the conversation people keep having with wisewon and others. Eddie Murphy is the right. We are the stunned wife walking in on him cheating.
Posted by: akaison | Jul 17, 2007 12:22:13 PM
“DM, I'm sorry you guys are having a hard time with the pregnancy. Learning as much as you can is obviously the right thing to do. But if your doctor tells you something different than the ideas you came in with, who are you going to go with? If you come in convinced that a generic of a certain medicine is just fine and your doctor says differently, who will you believe? Or, what if there's a generic for a certain drug that your doctor does believe is just fine, but your state legislature has made illegal to prescribe?”
Good question. I’ve had a number of interactions with our medical system over the last few years due to my dad and wife. I’ve come to the conclusion that Doctor’s, like many seasoned professionals, have to manage a myriad of information, research and customers, and aren’t always going to have the right information at the point of discussion. You can say I’m skeptical of Doctor’s; not because they’re not good at what they do, but because I’ve come to realize that they often have too much to handle.
The other interesting thing is that the Doctor’s we’ve worked with seem to appreciate that fact that we’re knowledgeable, we do our research and we ask tough questions. Our discussions become more collaborative and engaging. They, in turn, tend to spend more time with us and provide more insight and information.
Most decision’s we’ve made have been collaborative ones. My wife has decided on routes different than what our Doctor advises, but only because our Doctor’s advising, not deciding for us.
Per your question re: generics: if I had to pay full boat for the drug, I would strongly consider the generics; otherwise, I’d follow the Dr’s advice since the price makes no difference to me.
Per your last question: not sure.
And thanks for the comment re: the high-risk pregnancy. Things will turn out fine.
Posted by: DM | Jul 17, 2007 12:26:43 PM
From a purely clinical perspective, the newer one should be used
Really? That's only in the event that, from a clinical study, the newer one is more effective, even marginally so. Is this true across the board? Not necessarily. There are plenty of drugs (anti-depressents, for example) where one type isn't necessarily "more effective" than the other-- they just have different effects for different people, and the challenge is to go through the list until the patient finds one that works for him. Then again, the doctor might just decide to pick the newest drug that he has a bunch of samples of.
If it's my responsibility to know and understand every aspect of every drug - branded and generic - that I'm prescribed, then why the hell do I need a prescription?
This can't be emphasized enough when discussing medical issues. This is becoming yet another case in which we're trying to socialize the risks -- patients now have the onus upon them to make the best cost-benefit and clinical analyses of medical treatments -- while concentrating the rewards -- drug companies, pharmacists, and doctors get paid for signing off on the work we are expected to do. Why are we expected to do it? Well, because we couldn't POSSIBLY have any regulation come into play! That would be bad!
Any doctor will tell you that people should be responsible for their own health-- this is supposed to mean exercising, eating right, and following the advice of your doctor. Somehow this has morphed into meaning, "you have to absorb the risk and the labor involved with diagnosing your illness and making the optimal treatment choices."
Posted by: Tyro | Jul 17, 2007 12:52:36 PM
I'm not defending the status quo. So the Eddie Murphy joke doesn't apply. I'm in favor of as drastic a reform as others here-- I just don't think single-payer is the solution.
There is a major assumption made by single-payer proponents. Because our current-system fails that a market approach won't work. Half our health-care spending is already controlled by government (Medicare/Medicaid), so our current system failures point to failures with both government and market solutions.
Pointing to other countries that have single-payer is not really that helpful, while they have a great solution for UHC (which there are clear solutions beyond single-payer) they haven't solved cost growth problems, which is the major issue.
So let's step back for a second. From a gestalt perspective, no country has solved our biggest challenge-- cost growth.
Posted by: wisewon | Jul 17, 2007 12:58:42 PM
Is this true across the board? Not necessarily.
Seriously Tyro, its frustrating when you take my words so out of context. The sentence the immediately PRECEDES the ones you excerpted provide this exact caveat "In most situations." Either read more carefully or don't be so quick to find flaws.
Posted by: wisewon | Jul 17, 2007 1:03:40 PM
In our health care system, where doctors take tens of thousands from pharmaceutical companies and patients are bombarded with advertising to make them think they want, or know they want, certain drugs, the more expensive, no more effective, compounds will almost certainly remain atop the market.
You know, I keep hearing stuff like this, and I keep not seeing the tens of thousands of dollars. I'm married to a doctor and have been his office manager; where should this money be coming from, and where shall I put it on my tax forms? Do I need to put in a separate application with each drug company (Merck, Pfizer, etc)? Should I just apply this money directly towards malpractice insurance, or hold it aside for the conflict of interest lawsuit and medical board investigation that is almost bound to ensue?
I don't know who the heck these doctors are that are making money off drug reps. To me, drug reps represent a waste of time: either they take up clinical hours that could be spent seeing patients or filling out paperwork, or they mean I have fish sticks with the kids while my husband is off having a free meal at which he has to hear about -- oh just for example -- ways to treat pneumonia. Yeah that helps the digestion; I think I come out ahead on that one. Beyond that drug reps are a source of pens and notepads, and if you want to call that undue influence fine. Oh look, a pen with the name "Omacor", or "Omega-3 acid ethyl esters" is on my desk. That doesn't mean any particular patient needs it. I suppose he'd tell people to use more bicarbonate soda if he used Bic pens!
One point on which I will agree is that direct advertising of drugs to consumers is counterproductive. I would totally support informational ads that say things like "Hey, if you have these symptoms you might want to talk to your doctor. They may be an indicator of XYZ. This ad brought to you by Astra-Zeneca Pharmaceuticals." But as things stand, patients come in wanting a particular product, regardless of whether it is appropriate. This leaves the doctor in the position of arguing with the patient, or just giving them what he feels is the "wrong" medication just to shut them up. After all Marshall Field said "The customer is always right."
But hey, if you ever find those forms so I can claim the "tens of thousands of dollars," let me know.
Posted by: ShortWoman | Jul 17, 2007 1:11:49 PM
And thanks for the comment re: the high-risk pregnancy. Things will turn out fine.
BTW, I do hope that didn't come off as insincere. My wife will tell you that I'm a bit of a panicky type when it comes to pregnancy. It sounds like yours is better off in that department.
Posted by: Stephen | Jul 17, 2007 1:13:32 PM
wisewon, your argument seems to be that the problems of the health care system are being caused by people who have too much health care! That's not our problem at all.
I'm tempted to argue that we should cross the cost-growth bridge when we come to it. The problem now is that tens of millions of peopole don't have health insurance and tens of millions more can't innovate because they are chained to bad jobs simply because they offer health insurance.
Posted by: Tyro | Jul 17, 2007 1:16:11 PM
It didn't at all.
We were looking like 3 due to IVF plus one natural; but now it looks like it'll be only two, which reduces the risk significantly.
Posted by: DM | Jul 17, 2007 1:22:19 PM
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