The pattern is predictable. A few big-selling drugs face generic competition and drugmakers scramble to guard the gold. One way is to make it harder to pharmacists to switch. And that's the tactic being pursued by the Epilepsy Foundation, which receives substantial funding from a few drugmakers and has pharma execs on its board, plus PhRMA's Billy Tauzin. Four major brand-name drugs lose patent protection next year and 2010, but generated $5 billion in US sales last year,
The Wall Street Journal reports (subscription required).
In May 2006, the foundation convened a committee that found a lack of authoritative studies showing that such drug switches cause problems, says its chairman, Steven Schachter, a Harvard Medical School neurologist. Nonetheless, the foundation still recommended that docs give explicit approval for switches, citing anecdotal reports of seizures.
The foundation is lobbying hard in state legislatures to create exceptions for those pharmacy switches when it comes to generics for epilepsy. But members squawk at the perception they are shills for pharma. "These are people's lives that we're talking about - nothing about stock options and stock value and how this would affect [companies'] bottom line. That would be insulting to us to have discussions like that," Sindi Rosales, the head of a foundation affiliate in Texas, tells the paper.
But then there's an example in Georgia that undermines her protests, and is yet another example of how big pharma uses so-called patient-advocacy groups to camouflage its own motives....
The sponsor of a bill in Georgia, state Rep. Charlice Byrd, who says she was sympathetic because her mom had epilepsy, says a UCB official was the first person to raise the epilepsy-drug switching issue with her. The Belgian company makes the epilepsy drug Keppra.Charlotte Thompson, who's the foundation's Georgia affiliate, says she became aware of the bill after hearing about it from UCB. "When we realized (Byrd) was introducing this and looked at it and studied what it was, then we jumped on the bandwagon," Thompson says. Six lobbyists for three companies joined a committee created by the foundation to work on it.
Byrd says several pharma lobbyists offered support, such as Abbott lobbyist Guy Mosier, who Byrd says, "was extremely helpful working with legislators to help them understand the importance and that this piece of legislation was strictly for patient protection." Mosier declined to comment.
Byrd introduced the bill in the Georgia House in January. At a Feb. 7 hearing of the House's health committee, Lasa Joiner, executive director of the Georgia Psychiatric Physicians Association, testified in support. Joiner was at the time also a Glaxo lobbyist, which she didn't mention at the hearing. In an interview, she says she didn't raise her tie to Glaxo because the company hadn't asked her to lobby for the bill.
Two days later, epilepsy patients and parents of patients visited lawmakers' offices to ask them to support the bill. The foundation's Thompson says pharma lobbyists accompanied the visitors. The bill passed the Georgia House in a 161-0 vote on Feb. 28, but it stalled in the Senate after groups representing pharmacists and generic-drug makers mounted heftier opposition to it in that chamber. Pharmacies often earn bigger profit margins on generics than on branded drugs.
16 Comments
So anecdotal reports of suicide are reason to blame drug companies. Anecdotal repoorts of seizures - that could happen, say while driving and endanger the lives of others - are big pharma trying to get rich.
I guess I have to agree with you, pt. advocacy groups are a joke.
At least one tenet of the FDA gives them credibility in my book: "We are science-based. Show us the data."
Which means, BTW, that anecdotal evidence, while good for developing stories to recruit membership and for help pt. advocacy groups to raise funds for their activities, is NOT science and is NOT an acceptable basis for determining regulations and public policy.
After all, this is not simply a matter of justification for war, which is often based on anecdotal and hearsay evidence.
IMHO.
Wow someone on the board believes the FDA listens to hard data and is not in the pocket of pharma. I am going to quote you John. BTW, you might be the only other person on the board that actually know what anecdotal evidence means.
Interesting that patient "advocacy" groups are never concerned that epilepsy patients without insurance may not be able to afford paying 10 times as much for those brand name drugs. Many of these anticonvulsants are used for other indications other than epilepsy.
PHARMA spends a lot of money purchasing influence everywhere in this business.
I didn't realize they outlawed generics? I thought they were recommending a therapy. For narrow therapuetic index drugs, it might not be a bad idea to stick with what you have been taking - whether that is brand or generic. Any idea how the Orange book defines generics: 90%-125% of AUC of the original products. Some of these products also do not display linear pharmacokinetics, such as phenytoin with michealis-menton kinetics. So if you get a capsule with 125% of the AUC, this could result in doubling of free drug levels in the body. In a narrow TI drug, this could be an issue. If a doc wanted generic, all he has to do is write "phenytoin". It really isn't that tough. If the doc believes that due to medical condition a patient should be an the brand name drug that is working, this then ensures continuity.
Also, if a patient can't afford it - all manufacturers have an indigent patient program. So in all honesty, it could end up being free for that patient in need. So it ends up saving them the money they would have spent on the generic scrip. If there truly is a financial concern, patients should always talk to their phsycian about it. This helps them tailor the best therapy they can afford.
Your right though, it is interesting. A patient without money can stay on the therapy they need with no out of pocket cost. Those advocacy groups are awful, I hate them. They are almost as bad as drug companies.
"Those advocacy groups are awful, I hate them. They are almost as bad as drug companies." Most of the larger groups ARE the drug companies. Annual reports of the big ones makes for very interesting reading.
Re: FDA, science, and anecdotal evidence
I am willing to admit that some in the FDA may "bend" the science to help their pharma cronies. But to characterize the entire agency that way would be wrong. [Another 4 years of Bush-type Republican leadership, however, may make a liar out of me!]
Science also does not speak with one voice. Equally "scientific" data, I am sure, has been put into evidence on both sides of Vioxx trials, for example.
Still, if you are truly looking for links between cause and effect, the proper application of the scientific method is the only way to go. Unless, of course, you believe that snow is caused by cold weather because you only see it snow when it is cold. That's anecdotal evidence for you!
C'mon! Generics are tested on 2 to 3 dozen healthy volunteers, and the allowable bioavailability range is enormous. For drugs with a narrow therapeutic window like anti-epileptics, seizures and other problems are a real possibility. When Prozac first went generic, it was common knowledge among shrinks that some of the generic versions were to avoided at all costs, and there was even a favorite if a generic HAD to be substituted--it was the Par version. Patients were coming in saying that their drugs were no longer working.
Innovator companies spend billions on research, while generic companies like Teva are half lawyers, who start poring over patents the moment the NDA is submitted. Who are the greedy ones here? The innovators or the leeches?
"Still, if you are truly looking for links between cause and effect, the proper application of the scientific method is the only way to go." Using the above statement, what makes a patient reporting their symptoms in a clinical trial any different than a patient reporting their symptoms to a doctor? The big difference, as I see it, is that in clinical trials the partcipants are can be screened out due to certain conditions. How does this relate to "real world" use of any drug? The FDA has even admitted that the true test of a drug is when it is released to the general public. So while initial efficacy may be determined in clinical trial, a side effect profile can only be truly evaluated when introduced to a population of people whose real life circumstances would have gotten them screened out of a trial.
Laurie,
If you have time take a biostats class. You would then understand why you have to have similar groups with certain conditions excluded in order to determine the effects of the drug. No, many people have additional conditions, and that is why post marketing reporting is important. But it is too difficult to account for all the confounding variables if you just take a random sample of people. Also clinical trials are expensive. A large phase 3 trial of 6,000 people on average costs $100 million. That is a large phase 3 trial. How big do you want clinical trials, 1 million+ patients? The FDA has a huge balancing act - speed and cost versus absolute safety. Best bet is to not take a new drug for the first couple of years if possible.
If you think that clinical trials for innovator products are too small, take a look at generics. They have on average a bioavailability trial of 12-20 people and only look to see that blood levels are "close". So if you think large phase 3 trials are too small, think about the generic trials and how easy it would be to get bad data.
"Best bet is to not take a new drug for the first couple of years if possible."
Now that is something we can agree on. LOL!
Here in Australia the big pharmas don't have anywhere near the same power as the US. Therefore they don't spend significant amounts of money on supporting advocacy groups, hopefully that might change your opinion of their indepedence. However, we do have a generics issue because our Pharmaceutical Benefits Scheme (Govt funded) are always trying to reduce costs. We know that changing AEDs without proper supervision & management does lead to increased seizures (recent client survey not a clincial study). We also know that SUDEP (Sudden Unexplained Death in Epilepsy) has a strong correlation with break out seizures. Our arguement is similar to Sid's point, for narrow therapuetic index drugs, you SHOULD stick with what you have been taking - whether that is a brand or generic. Any change either way should be in a closely supervised situation by the approriate specialists. After all this is not an arguement in semantics or politics, it is about people and if we don't manage it properly then at worst people will die, lose driver's licences, possibly jobs or at best have their lives severley disrupted.
Jason—
You state: Also clinical trials are expensive. A large phase 3 trial of 6,000 people on average costs $100 million. That is a large phase 3 trial. How big do you want clinical trials, 1 million+ patients?
How much of this expense goes to pay doctors for “enrolling†patients? And the “large phase 3 trialsâ€â€”are they the norm, or the exception. As I looked back at the original application submitted to the FDA by Eli Lilly for rDNA human insulin—THE FIRST BIOTECH DRUG submitted for approval, and approved—the data indicated there were actually 6 trials. Tthe smallest trial comprised 6-12 patients; and the largest (most ‘meaningful’) had slightly more than 200. This, to me, is astounding. An unproven technology with no long-term data (of course) was given the green light with data collected from such a minute base!
Pharma may have changed their strategy, and may now finance ‘large phase 3 trials’—but somehow I believe they may be driven by more than data collection and efficacy/safety concerns. If they can compensate a few key opinion leaders for enrolling significant numbers, and acquiring predetermined answers, they can be reasonably certain there will be a substantial ROI.
6000 is by far above the norm. That is an example of a current trial going on for a new PPI, check out clinicaltrial.gov. Now that 6000 pts is spread among 400+ centers and over 50 countries. So if each center has 5 docs participating, you are looking at 3 patients per doc on average. I don't know about you, but I would be hard pressed to "cook" data for a drug company for a couple of grand. I don't know what the policies of academic centers are, but I am guessing that money goes straight to the institution and the doc never sees the money. Again, just like everything, I am sure there are bad people in medicine and pharma. It is unfortunate that we all get grouped together in your eyes.
So I guess everyone should pick a side - do you want large trials with more data or do you want small trials so pharma can't "buy docs".
Everything in this life is a trade-off.
Melody, I understand that insulin is your hot button like SSRI's for Lisa, but come on! I think the long term results of Humulin looks pretty good and is the gold standard. How come you don't rail on Novo like you do Lilly. I believe they produce synthetic insulin as well.
So let me get this straight, pharma sponsors large trials to pay docs, but then they don't collect the data? BTW when a big "primary care" type drug is tested, many more sites than not are community. These are not KOL's, but docs interested in advancing medicine. I have been involved in more than a couple and there is absolutely no one around for me to influence out in the country.
Docs are compensated for enrolling and treating/following patients. But honestly if a doc wanted to make money, he would stick to what he is good at and does on a daily basis. Trials slow you down, honestly. Maybe some have figured it out better than I have, but I would be better off running my practice in a normal fashion.
As you know all of the clinical trial stuff goes thru the proper channels before starting a trial - so no one for example is paying me $10k/patient to try out a new community acquired pneumonia drug. Instead for example, I scoped patients for a PPI trial. I got $3000 per patient for 4 visits and 2 scopes. This is actually about on par for what I would receive from Medicare. The patiet recieves free med and scopes and actually gets better care than they would have - at no cost to them. Plus I now have to mess with clinical monitors, mountains of paperwork, etc. So, if I were smart and just worried about my check, I would say forget it. But if you want to contribute to medicine you do what you feel is right.
I know it is much easier to think that all docs and drug companies are crooked, but some of are trying to do the right thing and get painted with a broad brush.
Take a look at Sid's post above - he is absolutely correct when it comes to the p'kinetics of AEDs. If you don't understand that post - you shouldn't be in the arguement.
Again, I will state I have never used Vioxx, Bextra, Ketek or any of the new wonder drugs. So I am not in pharma's pocket, I just actually read the literature.
Melody,
I don't know how I didn't think of this earlier with your anit-Lilly bent. I know you believe Lilly somehow manipulated everyone in the world to use their unproven unknown recompbinant insulin.
If it were really that easy don't you think that Exubra, Pfizer's inhaled insulin would have taken off. There is no bigger giant in pharma than Pfizer, on the surface an inhaled insulin sounds like the answer to a big chunk of diabetics problems. But the data isn't there and no one can really justify using the new insulin. I am sure Pfizer wishes they knew the Lilly insulin manipulation secret, but the secret is in the data. And for Exubra the data isn't there.
Jason--
First, a small mea culpa. It is ever so much easier to paint with a very broad brush, than to pick and choose. I realize there are GOOD doctors, there are GOOD researchers and there are GOOD medical educators. Actually, there are some good pharmaceutical products and some (almost ethical) pharmaceutical companies. There, now. I've apologized . . . nevertheless, I still contend that some of the above (who blacken ALL of the above when they behave so egregiously) are worthy of my 'anti' sentiments.
I merely criticize Lilly because they were first, and set the model. You state that human insulin is "the gold standard." Take a look at the application submitted to the patent office by Lilly's own researchers, where they admit the problems with their "new insulin" and compare it to the "gold standard" of basal insulin--Beef Ultralente. (Ahhh, how times and semantics change.)
Lilly can state (and the FTC agree) that they did not break anti-trust laws or engage in monopolistic behavior. But at the time they introduced rDNA human insulin, they were the major supplier of ANIMAL insulin (in the U.S. Squibb had already disappeared from the U.S. insulin market.) You may contend that they did NOT manipulate the market, but when husband was first encouraged to use the "latest and greatest" Lilly product, and declined, his doctor warned him that "the handwriting is on the wall. I've been told that Lilly is going to remove all animal insulins from the market." WHICH THEY DID--and which Novo mirrored, one product withdrawal at a time.
Unlike Pfizer's Exubera, diabetics currently still have a few choices (albeit far fewer than a decade ago). I fear that were Exubera a Lilly product, diabetics might expect that same kind of treatment. As patents expire for Humulin, Humalog, etc., and IF Lilly (as the hypothetical owner of Exubera) found the market were not rushing to embrace its new inhaled product--they would simply remove alternatives from the market! Unfortunately, for Pfizer, they do not have the luxury of such manipulation for this product.
You state that the data isn't in to support Exubera's claims. Neither did the data (even 4-5 years after its introduction)support human insulin need or superiority.
I am anti-Lilly. Not only my husband, but countless other diabetics who felt better, who achieved better release curves, who appreciated the predictability and uniformity of a wide range of natural insulins have been denied freedom of choice. UK, Australia, Canada, Germany, France, Switzerland, Poland, still provide a choice for their patients; the only "choice" for U.S. diabetics who cannot or choose not to use rDNA synthetic insulin (or analogs) that ARE NOT "just like the human body makes", is to navigate a cumbersome PERSONAL IMPORT regulatory process. For all intents and purposes, each order of needed or desired product is subject to confiscation by DHS; can be held indefinitely, regardless of time/temperature concerns; and requires planning months in advance of need to secure the medication.