Off Label Drugs and Free Speech

The Food and Drug Administration (FDA) has ruled that pharmaceutical companies cannot promote drugs for purposes other than the reasons for which the drug was approved. Physicians are free to do such off-label prescribing, however the drug companies cannot suggest in any way that physicians and other prescribers do so.

Companies have to do expensive studies to show that a medication is both safe and effective. How the FDA approves the drug is based on the research the company did. For example, Neurontin (gabapentin) is approved for certain kinds of seizures, post-herpetic neuralgia, and neuropathic pain. In 2004 Warner-Lambert paid $430 million in a court case brought by the government for off label use. The pharmaceutical company sales representatives had, promoted it for conditions including bipolar mental disorder, Amyotrophic Lateral Sclerosis, attention deficit disorder, migraine, and other conditions.

Some of those claims were true, and the company later received the nerve pain indications that it didn’t originally have. Physicians may rightly prescribe the medication without it having an indication because they have reasons to believe it may work based on the pharmacology or published studies. The pharmaceutical company may just not have been able to get it approved yet, or if it’s not a common problem, they may decide that financially it’s not worth the cost of getting an indication.

When a physician prescribes a medication, there is usually no direct economic benefit to them, and whether they are right or wrong, they will prescribe a medicine because they think it will benefit the patient. That’s not necessarily true of pharmaceutical companies, though. They have a direct economic incentive to sell as much of their product as possible, and their sales reps are often compensated on how many prescriptions the doctors they call on write. So although many of the reps are ethical, economic pressures are a strong incentive to get them to push for off label uses. Multi-million dollar settlements help hold those pressures in check.

Recently a three-judge panel of the Second Circuit Court of Appeals, in a case involving pharmaceutical sales rep Alfred Caronia, ruled that the FDA regulations violated the First Amendment’s guarantee of free speech. In an editorial the Wall Street Journal sided with the court, saying that, “health regulation is by nature health coercion.”

The Wall Street may smack down anything at all related to the Affordable Care Act (ObamaCare), but I think they are wrong. I’m not a lawyer, and much less a constitutional one, but I think of free speech in a different way. I don’t think selling a product is free speech. Selling an idea is. If you are not allowed to put up a sign touting you believe or don’t believe in God, for example, then your right to express your opinion is being abridged. If, however, you put up a sign saying the price of gasoline at your station, that’s not stating what you believe in, that’s just advertising. Granted, some cases might be fuzzy and I would err on the side of free speech, but sales reps talking about their medications are usually just advertizing. In fact the FDA does allow companies to support off label use, but it’s strictly limited (done by a physician in response to questions, etc.).

The Supreme Court acted in a similar manner in 2010 when they removed some limitations to political causes, allowing unlimited donations. This led to over a billion dollars donated in the last presidential cycle. It was done in the name of free speech, but because they could blanket the airwaves with ads, I’d argue those with less money basically lost some of their free speech to rich donors.

A lot of taxpayer money is spent on prescription medications. Busy physicians don’t have time to fact check every thing pharmaceutical sales reps tell them. Allowing reps to say whatever they want, in the name of free speech, is not good for anyone’s health, other than perhaps that of the pharmaceutical companies.

Tort Reform and the Sanctity of the Jury

I serve on WAMPAC, a political action committee for the Washington State Medical Association (WSMA). To help guide our members, last month we met with candidates for Washington State governor Rob McKenna and Jay Inslee.  They were both generous with their time and answered our questions.

As physicians, one of our issues is tort reform. We are concerned that large and unreasonable malpractice awards increase the cost of medical care and cause physicians to order unnecessary tests as ‘defensive medicine’. Attorney General Rob McKenna said he was supportive of tort reform, though didn’t give much specifics. Congressman Jay Inslee said he did not believe in malpractice caps because, he said, unlike others, juries are untainted and therefore we need to respect their decisions. That prompted me to send him the following letter. One month later, he has yet to respond. I wonder how I’ll vote in the primary?

Dear Mr. Inslee,

I enjoyed meeting you, and appreciate your spending time to talk with the Washington State Medical Association WAMPAC Committee 7/3/12 regarding your candidacy for governor.

On the issue of tort reform, you mentioned that you didn’t support malpractice caps because you believed in juries making the decision, as they are untainted by lobbyists or others.

Speaking for myself, I have some concerns about this. Short of Plato’s philosopher kings, juries may be the best choice to decide cases, but they are hardly perfect. There are numerous well documented cases of people sentenced to death, yet later found innocent by DNA evidence. In malpractice cases, I would argue that juries are far from perfect. How else could you explain the differences in the chances of being sued and the size of the award based on specialty (http://www.nejm.org/doi/full/10.1056/NEJMsa1012370)? The average neurosurgeon is sued once every 5 ½ years. You would be hard pressed to find a retired neurosurgeon who has never been sued.

Even if juries make perfectly logical decisions, it’s only as good as the cases presented to them, which may be flawed.

In cases where juries decide the outcome, there are restraints. There are judicial guidelines, and juries cannot impose the death penalty for shoplifting, for example, even if they wanted to. Putting financial caps on malpractice cases would be no different. The jury could still decide if the defendant is guilty, but guidelines would cap the size of the reward.

I hope you will reconsider your view on tort reform.

Sincerely,

Daniel Ginsberg, MD, FACP

Drug Shortages and the Joint Commission Stance

Periodically there have been drug shortages in the United States, which comes as a surprise to many. There are a number of reasons for this.

Recently one of my company’s pharmacists informed the physicians in my group of a nationwide shortage of bupivicaine and lidocaine, medications used for anesthesia, similar to what your dentist may give you before drilling your tooth.

I suggested that maybe we should be allowed to use such products past the expiration date until the shortage was resolved. They replied that they can’t do that because of Joint Commission standards.

So I wrote to the Joint Commission and eventually spoke with a nurse there. Their position was that it’s not safe to use a drug past its expiration date and they were just following guidelines by the Food and Drug Administration and others. I said that although I would generally agree that it is preferable not to use expired medications, in the case of shortages that may not be the case.

Imagine you have a life threatening infection with a bacterial organism resistant to all antibiotics but one, and there is a shortage of that antibiotic. In fact the hospital you are in has a box of antibiotics that expires at midnight tonight. They can give you only one dose then will have to throw away the rest, even though antibiotics would normally be given for 10 days and they don’t know when they will be able to get more.

Are you really safer as a result of throwing away the rest of the vials of the only antibiotic to treat your infection? In the interest of fair and balanced discussion I admit that I’ve eaten tuna fish after the date stamped on the can. But seriously, the risk of a complication from a slightly outdated medication is almost non-existent, and certainly less than the risk of going without.

Physicians going on medical missions to third world countries used to bring with them expired medications to administer to patients, the thought being that they were safe and better than nothing. Due to liability concerns, that pretty much doesn’t happen anymore, a fact said Joint Commission nurse brought up. In fact a 1997 article in the New England Journal of Medicine pointed out that at least half of the drugs donated to the Bosnian conflict were unusable because they had expired, and said pharmaceutical companies may have dumped the medications to get tax write offs and avoid disposal costs. That may have been the case, and could be addressed by not granting write offs for expired drugs, but that doesn’t mean they couldn’t have safely used the medications.

A 1979 law required pharmaceutical companies to give a date they guarantee the full potency and safety of a drug. They stand to gain financially when customers throw away good medicine because it has, “expired”. In fact the military conducted a study to see if they could extend how long they keep medications in order to cut back on the cost of destroying and replacing a billion dollars of inventory every 2-3 years. They found that 90% of the more than 100 drugs they tested were safe and effective up to 15 years after the expiration date. This program is now used by the Department of Defense, the Department of Veteran Affairs, the US Postal Service and the Bureau of Federal Prisons.

The nurse at the Joint Commission pointed out that I could decide whether the risk was warranted to use an expired drug. But in reality, I don’t get the chance to even discuss it with a patient to give them a choice. Hospitals risk a large financial penalty, and potentially even being shut down, for violating Joint Commission standards. Those drugs are going to go in the trash the day before they expire, shortage or no shortage.

I think the Joint Commission should modify their standards. At the least it should say that drugs should not be used after the expiration date unless their are shortages, or delivery problems due to disaster, in which case the medications should only be used if there are not suitable alternatives, and it’s felt that the benefits exceed the risks.

Rush to Judgement

Conservative radio show host Rush Limbaugh recently launched an attack on Georgetown University law student Sandra Fluke. She had testified to house Democrats in support of mandates to provide contraceptive care in insurance plans. On his show two days later, Rush Limbaugh said that Ms. Fluke  was asking for taxpayers to pay her to have sex, and that made her a, “prostitute”.

Others have chimed in that contraception is a lifestyle choice and society shouldn’t have to pay for it.  Whether or not you believe women have the right to get an abortion, it’s a flawed argument. By the same reasoning, insurance shouldn’t cover heart attacks, strokes or cancer if the person smoked or was obese. It’s one thing to incentive healthy behavior, but Rush Limbaugh’s attack is either not well thought out in regards to its health care implications, it’s misogynistic, or it’s politically motivated.

Let the Sunshine In, Let the Sunshine In

A GlaxoSmithKline representative came by to drop off samples in my office and asked if there was anything else they could do for us. GSK makes some inhalers so I asked if they could supply spacers to give to patients, something they used to do. Spacers come in different designs, but basically it’s a plastic tube that fits between an inhaler, such as albuterol, and the mouth. The extra distance causes the medication particles to get smaller, so they deposit deeper in the lungs. The spacers are relatively inexpensive, probably less than the cost of the inhaler for a week, and can last years, but because insurance companies usually don’t cover them, patient’s usually don’t get them. Handing one out in the physician office is a good way to get patients to use one, plus the proper use can be demonstrated in the office.

The representative said that his company was not giving the spacers, and in light of the Physician Payment Sunshine Act, doubted they would. This proposed regulation of the Centers for Medicare and Medicaid Services (CMS), part of Section 6002 of the Affordable Care Act, stipulates that, effective 3/1/12, that pharmaceutical companies report payments to physicians over $10. It makes no difference whether the spacers are for the physician, or their patients.

The purpose of the Physician Payment Sunshine Act is to discourage physicians from making prescription decisions based on financial inducements. Just to be clear, pharmaceutical companies don’t just give physicians cash to prescribe their medications, which would clearly be immoral, if not illegal, but can give other incentives in the form of meals, books, speaking fees, etc. In this case, however, the reporting requirements are not consistent and don’t make sense. They don’t have to report leaving samples of their inhaler, which costs far more than a spacer, but they would have to report the spacer, even though it could be used with inhalers made by other manufacturers. Although in balance I like having samples, they tend to encourage one to prescribe them since we don’t have generic samples. I think insurance companies would save money providing free generic samples, but that’s another story.

The bill was introduced by senators Charles Grassley, R-Iowa, and Herb Kohl, D-Wisconsin. As recently reported by 60 Minutes, congressmen can legally trade on insider information, so this law was hypocritical (in fact I see that only 25% of the Sunshine Act sponsors senators are sponsoring the Stop Trading on Congressional Knowledge Act  S.1871 or S.1903 bills) . But as physicians we are ‘Hippocratical‘ and hold ourselves to a higher standard. That said, I think there are many instances where it’s legitimate for physicians to accept items of value from pharmaceutical companies.

The science of medicine advances at a fast rate, and it’s difficult, if not impossible, to keep up to date. This is true for specialists, and even more so for primary care physicians. The majority of medications I prescribe every day were not available when I was a resident in training. One way I help stay up to date is to listen to pharmaceutical representatives, or physicians they bring in, while I eat a meal they provide. There is no quid pro quo agreement to prescribe their medications, and many a rep can attest that I frequently challenge what they say. But what they do get is some of my time and a chance to present information that ultimately may benefit my patients. True, there are other ways to get the information, but time is the problem. I have to eat, so that’s a good time to talk. Listening to top physicians they’ve flown in, and having the opportunity to ask questions, is very valuable. I also participate in research trials (needed to create new medications), and those fees will show up in the database. The act would not make such payments illegal, but the concern is that the public will not be able to put the numbers in context and it may incorrectly imply impropriety.

Physicians and other providers do need to be careful they are not unduly biased by pharmaceutical companies, and I have a lot of concerns about pricing manipulations of medical drugs, but when it comes to the Physician Payment Sunshine Act, I think it’s pointing a light at the wrong place, or at least with too broad a beam.

Right for the Wrong Reason?

In 2007, Texas Governor Rick Perry signed an executive order mandating that teenage girls be vaccinated with Gardasil, a vaccine that helps prevent cervical cancer by providing protection against Human Pappillomavirus, or HPV. This was subsequently overturned by the Texas legislature. Now it’s a matter of discussion among Republican presidential candidates. Representative Michelle Bachmann has criticized not only that, ““To have innocent little 12-year-old girls be forced to have a government injection …is just flat out wrong,” but has also suggested that he was motivated by political donations from pharmaceutical company Merck.

We’ll have to see how things play out in regards to whether Governor Perry made his initial decision because of political donations, but it least has the appearance of impropriety.

From a medical point of view, I think he was right to mandate vaccination against HPV, even if he did so for the wrong reason. According to the CDC and the American Cancer Society, at least half of sexually active people will get infected with HPV in their life. Half of those people are infected between 15 and 24 year of age.

In the United States, about 12,000 women are diagnosed with cervical cancer, and 4,000 die from it, each year. HPV causes most of these, as well as many cases of anal and oropharyngeal (mouth and throat) cancer, and genital warts.

As a father of daughters, I get that when they’re 10 to 12-years-old, you don’t want to think of them being sexually active. But most people eventually are, and you can’t be certain that it will only be with one uninfected person the rest of their life. Once they’re infected, it’s too late.

The policy for vaccination against HPV should not be different than for other infectious disease, such as tetanus, polio, measles and chicken pox. If you love your children, you should seriously consider vaccinating them. Even if he had ulterior motives, I think Governor Perry had the right idea.

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