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Who Should Determine Drug Labeling Language: Juries Or The FDA?

Photo of FDA

Wyeth vs. Levine is an important legal case being tried before the US Supreme Court. You may have read about the lawsuit in the New York Times, NEJM, JAMA, the Wall Street Journal, or my own blog. It revolves around the tragic story of a woman (Ms. Levine) who experienced an extremely rare side effect (severe tissue damage resulting in the amputation of her right arm) because a drug was administered improperly (into an artery rather than a vein). Ms. Levine is arguing that her injury could have been avoided if the drug label had stronger warning language, and the Vermont Supreme Court ruled in her favor, awarding her $7 million. The court ruled that a jury in the state of Vermont had the right to hold Wyeth accountable for a different labeling standard than the one approved by the FDA.

The plot thickens, however, in that Wyeth’s FDA-approved label very clearly discourages injection of their drug into or near an artery, and it also describes the potential consequence (including gangrene) of such an action. The FDA approved Wyeth’s label in full knowledge of the potential risks and benefits of the drug. In fact, Wyeth asked to strengthen the language of the label before Ms. Levine was injured, and the FDA declined to make the change because label changes are based on new information about a drug’s frequency or severity of risks. Wyeth had nothing new to disclose. Read more »

Is Raw Milk Getting A Raw Deal?

I’ve written about raw milk before, but here again we find it making front page news. There has been a recent FDA raw milk crack down in California, and I believe that’s a good thing for public health reasons. Although raw milk enthusiasts ascribe mystical powers to the product (some say its natural microbial flora can cure everything from asthma to autism), I don’t see anything mystical about the pathogens that can grow in room temperature milk: e. coli, salmonella, listeria and even tuberculosis. If you like the taste of raw milk and don’t mind the risks associated with imbibing warm body fluids of manure-encrusted bovines… then go right ahead. But please, don’t put your children at risk.

The New York Times exposed the raw milk counter-culture phenomenon last year.  Grocery store milk has been heated and packaged in a nearly sterile fashion so that no harmful bacteria are in it.  Farmers collect raw milk from cows, then send it to a processing plant where it’s pasteurized (a heat treatment) and homogenized (blending the creamy part with the skim part) it before packaging the milk for human consumption.  This process has virtually eliminated milk borne illness in this country, but now certain farmers are threatening to reverse that progress.

So why are people fascinated with raw milk and seeking out farmers who will sell them milk prior to heat treatment?  Raw milk does taste very good, and there’s no doubt that the creamy layer that floats on the top is delicious.  In New York City raw milk has a black market, cult following.  Should you jump on the bandwagon?

As my regular readers know, I grew up on an organic dairy farm, and had the pleasure of handling cows up close and personal for at least a decade.  In fact, their sweet-smelling grass breath, and not so sweet-smelling cow patties are etched permanently in my mind.  Cows are curious, somewhat dim witted, and generally oblivious to the terrain upon which they tread.

Cows will stand in manure for hours without a moment’s regret, should you present them with fresh hay to eat or some nice shortfeed.  They drop patties on the ground, in their troughs, and occasionally on one other.  Their flicking tails often get caked with manure as they swish flies away and they scratch their udders with dirty hooves as well.

This is why when it comes time to milk them, farmers need to wipe their udders carefully with a disinfectant scrub before applying the milk machine.  Mastitis (or infection of the udder teets) is not uncommon, and is a reason for ceasing to milk a cow until the infection has cleared.

And so, the cleanliness of raw milk depends upon whether or not the farmer removes all the excrement carefully, scrubs the teets well, and remembers not to milk the cows with mastitits.  It also matters whether or not the cows are harboring certain strains of bacteria – which often don’t harm the cow, but cause very serious problems for humans.

Did I drink raw milk as a kid?  Occasionally, yes.  Were my parents super-careful about the cleanliness of the milk?  Yes.  Did I ever get sick from raw milk?  No.  Would I give raw milk to my kids?  No.

I appreciate that epicures want to experience the flavor of raw foods, but for me, the risks are simply not worth it when it comes to milk.  There is no appreciable nutritional benefit to drinking raw milk (in fact, store bought milk is fortified with Vitamin D, which is critical for healthy bones), and it caries a small risk of serious infection.  I agree with the FDA’s ban on interstate sales of unpasteurized milk, and would not want to see raw milk available widely for general consumption.  Of course, to get around this ban, some companies are selling raw milk and cheese under the label “pet food.”

It’s a crazy country we live in – anti-bacterial hand wipes, soaps, gels, plastics and an insatiable appetite for raw milk.  As a doctor, I throw up my hands.  Is raw milk getting a raw deal? Some farmers may feel that way – but this former farmer is pleased to have access to safe, clean milk. What do you think?This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.

Are FDA Regulators Preventing the Terminally Ill From Accessing Promising New Cancer Drugs?

Sen. Sam Brownback (R-Kans.) and Rep. Diane Watson (D-Calif.) held a press conference on May 21 to announce the introduction of the Access, Compassion, Care, and Ethics for Seriously Ill Patients Act. The ACCESS Act seeks to increase terminally ill patients’ access to promising treatments in the investigational phase of Food and Drug Administration (FDA) approval.

I had the chance to interview one of the speakers at the press conference, Emil J. Freireich, M.D., the director of the Adult Leukemia Research Program at M.D. Anderson Cancer Center at The University of Texas. His opinions are quite provocative.

Dr. Val: You’ve expressed frustration with the FDA’s cancer drug approval process, especially as it pertains to terminally ill patients and investigational drugs. What’s the source of your frustration?

Dr. Freireich: The problem with the FDA and the research process in this country is that it’s too risk-averse. Twenty-five thousand Americans die in car accidents each year, but we don’t ban cars. Five-hundred thousand Americans die of cancer each year, and the FDA makes it impossible for many of them to get the drugs they need. What’s the sense in that?

The excessive red tape [slowing down the research pipeline] is caused primarily by legislation created at the time of the thalidomide disaster [1957-1961]. They made a mistake in marketing a sedative to an untested population group of pregnant women, and that resulted in the alarming birth-defect consequences. However, because everybody panicked, now the FDA regulates the earliest development of a drug. The whole process of drug approval changed.

Treatment of human beings for disease is the only area of research where the scientists who know about it have to petition the government to begin to do research. I can do research in physics, chemistry, astronomy or any science. But if I’m going to do medical research, I have to petition the government first even for animal studies.

The FDA should not have power over the Investigational New Drug (IND) process. Scientists should not have to petition nonscientists to do research. The FDA is always seeking more scientists to work for them — but they’ll never get enough because what kind of scientist wants to sit behind a desk and approve someone else’s research? If you’re creative and innovative, you want to do your own research.

Dr. Val: Let me ask you about funding. The health care system has a limited amount of money — how can you justify spending it on investigational drugs for the terminally ill?

Dr. Freireich: Of  the $50 million used to bring a drug to market, $49.5 million is used to satisfy regulators. That’s where the money goes. If you are in a pharmaceutical company and you want to get approval for your drug, you have to hire people who used to work at the FDA to figure out what hoops they’re likely to require you to jump through.

And how does the FDA decide how the drug should be developed? By consulting the world’s leading scientists and researchers? No. Regulators make up the rules on a whim. They stipulate things like: “Before you can do human trials, you have to kill 1,000 monkeys in Africa, and then 4,000 rats in China. And if you bring home that data, we’ll be sure to approve the drug. Then pharma goes to venture capitalists to pay for the monkey and rat trials, and the FDA approves the drug for human trials. But to make sure that the maximal benefit is observed in the trial, participants have to be young Olympic athletes with normal kidneys, livers, a full head of hair, nice teeth and a small cancer. Meanwhile all my patients are dying as they’re ineligible to participate.

Take Gleevec for example. Chronic myelogenous leukemia (CML) used to have a median survival rate of 3 1/2 years (90 percent of people were dead in five to six years). Today 90 percent of people with CML have a 10-year survival rate. And that’s the result of just one drug. When we gave Gleevec to the first 10 patients, it was obvious how powerful it was. But we were required to do a randomized trial that took two years, and half the patients were given interferon — which we knew wouldn’t cure them. I had a patient who was on the board of directors of Novartis. He had CML, and he had all the data, and he knew he needed Gleevec. He entered the trial and happened to be randomized to the interferon arm and died. This shows you that the venture capitalists and administration of pharma are powerless. They can only do what these powerful FDA regulators allow.

Some of the regulators are 25-year-old college graduates, and they essentially control the lives of millions of people. All they have to do is sit at their desk and say “no” all day long to trials. Regulators have no incentive to approve drugs for trial because of risk aversion. I could create a cure for cancer, but if one person dies in a trial, then they’d fire the FDA guy who approved it. Then if they’re really smart, they go over to the industry side and get a tenfold pay raise and make more than the researchers and doctors who are trying to save the lives of cancer patients.

Dr. Val: What about all the research that is unregulated? The research in alternative medicines, for example?

Dr. Freireich: The tragedy is that the FDA can’t touch alternative medicine practices. FDA regulation only hinders the legitimate scientists, while the quacks get off scot-free. This is due to the “consequence of the unintended.” The legislation wasn’t intended to control quacks, but it controls legitimate scientists. Why? Because the government funds 30 percent of all research in this country. If I say to my research lab director: “I have a drug that can cure leukemia, but the FDA won’t let me test it — let’s just do test it without their approval.” He’ll respond: “Guess what? Thirty percent of our budget will disappear in five minutes.”

At the same time that I can’t get FDA approval to test promising drug therapies, there’s a quack in Houston who sells urine extracts to cure cancer. Why doesn’t the FDA touch him? He doesn’t accept federal funds, so he can do what he wants. In a sense, the quack movement is indirectly fed by the FDA. If patients could get legitimate treatments from doctors, they wouldn’t be turning to quacks. The problem is that they come to me and I have to tell them that they’re not qualified for clinical trials. The patients we turn away from M.D. Anderson go straight to the quacks. What else can they do? You can either pray, go to a quack or go on the Internet to look for miracle cures.

Tragically, if it takes 10 years to develop a cancer drug, 5 million people die while waiting for it to be approved. That same drug could be developed in one year, but we’re being regulated in areas where it’s not needed. The FDA should be worrying about the drugs we give to healthy people, not worrying about sick people — that’s the doctor’s job.

Dr. Val: Well, what do you suggest we do about this?

Dr. Freireich: The solution is legislation. Why does the public put up with the current IND process? Because most of the public is healthy. Healthy people never envision themselves getting sick. If you’re healthy, you don’t think about cancer happening to you. We need to wake up and support the ACCESS Act legislation.

***

Addendum: I spoke with Selma Schimmel, the CEO of Vital Options International, a cancer advocacy group, about her perception of the investigative drug process. She said that while she is sympathetic to cancer patients’ eagerness to gain access to drugs, she wouldn’t want them to be harmed by investigative drugs either. Schimmel says that the FDA is in a difficult position in which staff are held accountable for an incredibly high standard of safety — and yet the agency is being asked to push things through quickly.

This ACCESS Act has been a topic of debate for some time and was discussed here.

Another article of interest about FDA and Medicare joining forces to form an early warning drug network was published in the LA Times today.

What do you think of this issue?This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.

New FDA Rule Raises Bar for Supplement Industry

Well, hooray for the FDA.  On August 24th a new rule will be phased in, requiring all supplement manufacturers to demonstrate that their products contain the ingredients listed on their labels (nothing more, nothing less).  This rule will help to reduce contamination issues (some supplements have been found to contain dangerous levels of lead, bacteria, and other contaminants) and false advertising (some supplements don’t contain as much of an ingredient as the label claims).

This is really good news, and better late than never.  Although some manufacturers were already conforming to this rule (kudos to them), this will require compliance for the rest of the companies out there who have been misleading the public about the contents of their supplements.

Some say that this rule doesn’t go far enough to ensure the safety and efficacy of the contents of the supplements, and that these bio-active ingredients should undergo the same degree of testing as pharmaceutical products.  Unfortunately, studying all the supplements for efficacy would be an enormous and extremely expensive task that is totally cost-prohibitive.  At this point, the best we’ve got is NCCAM, and they are slowly grinding their way through a long list of supplements that are purported to be useful for the treatment of various conditions.  They are systematically reviewing them to see if indeed they produce the desired effect, without any undesired effects.

And so at this point, let the buyer beware – supplements may or may not be as helpful as the manufacturer claims, and they may not be as side-effect free as they suggest either.  But soon you’ll at least be able to know that they don’t contain toxic chemicals, heavy metals, or dangerous bacteria – and that’s a giant step in the right direction for public safety.This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.

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