Last spring, in the midst of all the hullabaloo surrounding Alabama’s 2012 legislative session, a particularly dreadful health related bill was quietly set aside without much public knowledge. I wanted to write about it but was asked not to—I had already made some folks angry in our statehouse over Medicaid funding, and I was told my involvement might interfere with others being able to help this bad bill go away. With some difficulty and uneasiness, I kept my mouth shut. I would have felt awful if it had passed because of my big mouth! Now I see the bill we thought was dead has risen again for 2013. I’m going to tell you the whole tale before I get cold feet.
On the evening of April 17, 2012, I got an email from a reporter in Montgomery saying he was doing a story on “the Governor discontinuing to allow doctors to prescribe palivizumap [sic, palivizumab] for premature babies or any babies.” The reporter said there was a bill, SB 196, that would “keep [palivizumab] in the Medicaid formulary.” He wanted to know my thoughts.
I was startled—palivizumab, brand name Synagis, is an injected antibody for high-risk babies to cut down risk of severe RSV (respiratory syncytial virus) infection. RSV is the bane of winter for pediatricians and parents of young infants. As this article explains, the virus is “ubiquitous”, so unless you live in a bubble you are going to catch it more than a few times in your life. In very premature or certain other high risk babies, RSV can create havoc—wheezing, inability to breathe well enough to feed, and sometimes bad enough illness to require the ICU and a ventilator. Sometimes it kills babies. Palivizumab doesn’t totally prevent RSV and does NOT reduce the overall death rate, but it does cut down on the number of hospitalizations needed for these high-risk infants. Notice the risk groups described in the article I linked to? Not every premature infant will benefit.
I couldn’t imagine why Governor Bentley would try to ban palivizumab and thought I would have heard of something so drastic . So I read the bill. It was full of meaningless stuff about streamlining the Medicaid prior authorization for premature infants, implying that this was somehow especially difficult (it isn’t). Big whoop-de-do. Finally towards the end there was this line: Alabama Medicaid must “[e]nsure that all medicines that are prescribed to premature infants shall be given, at a minimum, in the dosage and duration as directed by the product’s Prescribing Information provided by the Food and Drug Administration.” The bill didn’t mention palivizumab, but as soon as I read that line, I knew. This had to be a drug company bill. I got goose-bumps. To me, that’s even scarier than ALEC. When drug companies start writing our state legislation, we are in big, big trouble.
I called some friends in Montgomery and had my suspicions confirmed that SB 196 was being called the “MedImmune bill”—MedImmune is the company that makes palivizumab. If used according to the FDA guidelines applied to ALL infants born at less than 37 weeks gestation, this bill would have cost our state about $9 million extra a year with no clear additional benefit. The FDA specifies it is to be used for prevention in high risk groups of pediatric patients (but gives no age limit or definition of high risk), for the duration of RSV season, usually 5 months in the Northern hemisphere. Pediatricians and insurers, including Alabama Medicaid, use published research and guidelines to decide when to prescribe palivizumab and the number of doses to give for each group (5 for some, 3 for others), and SB 196 would have prevented us from practicing according to good evidence.
Here is what the bill really says, in effect: “Medicaid must ensure that palivizumab is given to babies who shouldn’t get it at all, according to the best research, and that babies who should only get 3 doses are given 5 instead.” Intentionally giving unneeded medication or more doses than are needed to babies is at best fraud and at worst malpractice.
You can read the palivizumab guidelines for Alabama Medicaid and from BCBS Alabama. The same, and the same as in the AAP guidelines I already cited. Notice the language of the bill tells Medicaid it must “ensure” medications are given at certain doses and durations when prescribed, not just that it must approve them if asked (which would be bad enough). That implies it must require participating physicians to toe the MedImmune line. I told the reporter this, although I requested he keep me anonymous, and explained to him that the Governor and Medicaid were not trying to stop doctors from using palivizumab appropriately. They were doing the right thing, at political risk—we owe them gratitude for this particular stewardship of valuable resources and child health.
The more I thought about the situation, the more concerned I got. I avoid talking to drug reps, because I don’t want to accidentally remember misinformation, but I decided to look up the contact info for our area MedImmune rep. Michael Petrucelli responded to my email on April 18 very quickly that the best person to talk to was MedImmune’s Government Affairs Manager, Joel Batten, and gave me the phone number.
Feeling a bit like Mata Hari, I called Mr. Batten, who said he was expecting my call. I confess I pretended to be confused over the legislation and did not let on that I was trying to dig up dirt. I should probably do some sort of penance. We had a long conversation. He said he was keeping track of the bill “on a daily basis.” I asked him if he knew where our legislators got the idea for it, and he said it had been a two year process. He said one legislator had noticed infant mortality was 20 to 30% in some of his districts (???—some rural counties are indeed over 20 or 30 per 1000 in recent years, but nowhere in Alabama is it 20 to 30%) and “that’s where we came in.” He said the senator he talked to was “surprised to learn that any medication wasn’t being given according to FDA guidelines”, but he wouldn’t tell me how the senator came by this information. I’m not going to give that senator’s name, because I got it second-hand from Mr. Batten and can’t confirm the accuracy. He said MedImmune was mainly concerned about the 34 week babies only getting 3 doses instead of 5. Mr. Batten then said that “someone in the Governor’s office contacted someone in the House to say Governor Bentley is opposed to the bill” (that would have forced Medicaid to require inappropriate prescriptions of palivizumab). He said “politically it could be a bad idea for the Governor to oppose it since it would benefit children.” So you can see the depth of this drug company manager’s involvement with our legislative process!
By some unknown route, certain of our legislators have gotten the wrong idea that Alabama babies are dying because they aren’t getting enough doses of palivizumab. I have my ideas about how this misinformation got to them, don’t you? I sent the quotes from my conversation with Mr. Batten to the reporter. I imagine he was unable to use them because of my request for anonymity—all I saw changed in his piece was the corrected spelling of palivizumab. I certainly appreciate that he did protect his source when asked. Not too long after this, I was told our legislators had been made aware of the true nature of this bill and that it was going to be quietly abandoned. Now, here is SB 3, already pre-filed for the 2013 session. Same bill, so far as I can tell.
Infant mortality in Alabama is certainly a travesty. Death rates of over 20 per 1000 births in some counties put us in third world country territory. But these sad numbers have nothing to do with palivizumab, which has never been proven to decrease the death rate anyway. The deaths are primarily related to prematurity and lack of prenatal care. Universal insurance, expansion of our rural labor and delivery capacity, and rural prenatal clinics in the state are critically needed. Diverting millions of dollars and legislative effort on the wrong solution will not help matters.
Tying use of a medication legislatively to the FDA guidelines is extraordinarily worrisome. The initial approval of new drugs is based on data submitted by the drug companies, with paid applications. They are not required to have research done by an outside agency or to publish their data in peer-reviewed journals for these applications. Many of the uses, doses and regimens of medications come about well after a drug has been originally approved. It is usually not cost-effective for a company to pay for a new use or dosage of a drug to be approved, so with every year that passes, the FDA information becomes more and more outdated.
If I stuck with the FDA guidelines and could not prescribe “off label”, I would be unable to prescribe a good many necessary medicines for children, because the drug companies never even bothered to get approval for that age group. Like other pediatricians, I rely on published studies and professional guidelines instead. Very often, I need to use a far different dose for a medication than the FDA lists, either because of new evidence or because children metabolize some medications differently than adults and may need higher or lower doses for weight. If I stuck with the FDA doses for penicillin or amoxicillin, I would be using the wrong doses for strep throat! I would be going against the advice of the CDC and other infectious disease organizations.
For newborns, the dose of gentamicin (an antibiotic) is now significantly lower than the FDA approved pediatric dose per weight and is correctly given at 24 hr intervals instead of every 8 hours. SB 3, because it applies to ALL drugs given to premature infants, would require Medicaid to be sure I overdosed a premature newborn with gentamicin and risked permanent kidney damage. Don’t worry, I wouldn’t do it. I’d have to commit civil disobedience.
Other than the cost, is there any drawback to prescribing palivizumab to babies who wouldn’t benefit? Possibly, even though it appears to be generally a very safe medication. The published rate of anaphylaxis (life-threatening allergic reaction) is extremely low, but when I have ordered palivizumab for preemies in my practice, it has come with its own epinephrine syringe, pre-loaded with the correct dose for that patient. I find that puzzling—any doctor’s office should have epinephrine at the ready, and I don’t get a pre-dosed syringe with other medications. Why is the pharmacy who supplies it so nervous? For a new drug, there is a substantial period after approval when unexpected side effects may show up. Even with acetaminophen (Tylenol), reports of possible links to asthma development took decades to emerge. If we were to start using palivizumab for all preemies, would we start seeing more side effects? I do not know, but as a parent and a doctor, I would not want to give a child ANY medication that was not necessary.
Alabama Medicaid funding is always on the edge these days. If we are forced to waste millions of dollars on unnecessary medication, we may have to cut other important services. As closely involved as MedImmune is in our legislative processes now, I would be surprised if they didn’t know our budget woes. That MedImmune would jeopardize children’s health services and force babies to be given unneeded drugs in order to line their pockets astonishes me. It should not, but it does.
I will admit I had some anxiety about my personal risk in writing about this. I still do-- MedImmune is a large, powerful company. This is big money for them, and we may be a sort of test state for the legislation. I have to imagine other drug companies are dreaming up how they can cash in on similar bills for other products. I don’t know if there will be retaliation for what I’m telling you. But the cost of knowing what they are up to and NOT speaking up is too high. You need to know these things. I have a duty to protect my patients.
If you are reading this from out of state, please take a few minutes to find out if similar bills are in the pipeline where you live. If you are in Alabama, please write or call the Senate health committee members today, and let them know you are opposed to drug companies writing legislation for our state. Tell them SB 3 could force doctors to commit malpractice on babies. Tell them the pace of medical research and scientific advance is far too rapid to be set in stone, and explain to them why the FDA guidelines are not an appropriate standard. They may truly not understand this, since it is a bit esoteric—you may not have known before either! Now you do. Tell them Medicaid and physicians need to be allowed to use the most up to date research, for the safety of children in our state, without the interference of drug company lobbyists. Tell them to squash SB 3.