Archives for January 2013

Late last Friday, an advisory panel to the US Food and Drug Administration voted – far from unanimously – to toughen restrictions on painkillers such as Vicodin, which contain the opioid hydrocodone. Typically, the FDA takes the advice of such advisory committees.

Bad, bad, bad move.

As always seems to happen in the tortuous world of pain and painkilling drugs, the loudest voices came from those concerned about prescription painkiller abuse, with the voices of legitimate pain patients relatively silenced. To wit: The committee voted 19 to 10 to tighten restrictions in the belief – mistaken, I believe – that such tightening would help combat abuse.

In reality, it might not help combat abuse much, if at all, and would certainly mean that legitimate pain patients will have a tougher time getting the opioids (formerly called narcotics) that they need to function.

For one thing, it should be clear by now that the much-touted war on drugs has failed. Indeed, recent evidence shows that the more the government tries to combat abuse, the more street addicts and abusers find ways around the restrictions. In a July, 2012 letter to the New England Journal of Medicine, for instance, researchers from Washington University reported that after OxyContin was made more tamper-resistant, abusers simply began turning to heroin instead.(1)

More to the point, if the FDA goes ahead and tightens restrictions, chronic pain patients – who number 100 million, according to the Institute of Medicine – will suffer. In testimony to the panel on Friday, Massachusetts pain patient Cindy Steinberg, Policy Chair for the Massachusetts Pain Initiative and New England Director for the American Chronic Pain Association, explained the toll chronic pain takes on sufferers and argued that hydrocodone medications, which she herself takes, should not, as proposed be moved from their current less restrictive status (so-called Schedule III drugs) into the more restrictive catgory (Schedule II).

Among other things, if the FDA accepts the advisory panel’s recommendation, it will no longer be possible for pain patients to get refills via called-in or faxed prescriptions from doctors. This means patients will have to go physically to the doctor every time they need a refill, a major obstacle for people in severe pain with mobility problems.

If you are a pain patient concerned about access to opioids, it is not too late to make your voice heard. Since June, 2012, the FDA has maintained a docket on which you can voice your opinion, but that docket will close on Friday, Feb. 1. The docket number is FDA-2012-N-0548. The link to submit electronic comments is http://www.regulations.gov/#!home;tab=search.

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(1) Cicero, T.J., Ellis, M.S., &Surratt, H.L. (2012). Effect of abuse-deterrent formulation of OxyContin [Letter to the editor]. New England Journal of Medicine, 367, 187-198.

 

It was almost child’s play.

Using a computer, an Internet connection and information available publicly online, researchers from the Whitehead Institute at MIT were able to figure out the identities of nearly 50 people who had submitted personal genetic information for a research study — information that purportedly had been “de-identified” so as to protect the subjects privacy.

Cracking the supposedly secret code turned out to be ridiculously simple, Yaniv Erlich, a Whitehead human genetics researcher, told the New York Times. “Oh, my God, we really did this. I had to digest it. We had so much information.” Erlich’s team quickly told the National Institutes of Health about the vulnerability of the information. The agency has taken steps to make re-identifying research subjects harder to do.

Great. But there’s a big issue of trust here. With this latest “Oops!” moment in the world of “Internet privacy,” that term itself seems well on its way to becoming an oxymoron. Particularly for health information.

No one is more concerned about this than Texas psychiatrist Dr. Deborah C. Peel, head of the Patient Privacy Rights Foundation. “We are actually in a very bad situation,” she told me by phone last week. “There is no way to protect your privacy today except to pay cash to a doctor who will keep your records on paper.”

For the record, Peel truly believes that there are many benefits to doctors, hospitals, insurers and researchers sharing information about patients and research subjects, for both the individual and the common good.

“The benefits of health technology systems are clear. We all know that. The problem is, we don’t know anything about the risks, about who has the data,” she said. In other words, it is unfair to ask people to balance the risks and benefits of electronic record sharing if they don’t know what the risks are. As it is now, she added, “everyone sells health data because it is so valuable. We live in a surveillance economy and the most valuable information is health information.”

At Harvard, a medical informatics specialist Latanya Sweeney runs the Data Privacy Lab and is working on a so-called DataMap. Personal health data can now be sent in an instant to growing numbers of people and organizations.

In fact, as an ABC investigation reported last fall, “millions of records can be bought online.”

To be fair, there are some decent souls inside the health care system trying to protect health privacy, among them Dr. John Halamka, chief information officer at Beth Israel Deaconess Medical Center. And Halamka is reasonably upbeat about the possibility of protecting data security.

On January 17, he told me, new HIPAA regulations were released that are designed to enhance health privacy. (HIPAA stands for the Health Insurance Portability and Accountability Act, originally passed in 1996.)

With the new regulations in place, huge fines ($1.5 million a year) will accrue to any hospital — or other organization in the chain of groups receiving personal health data — that fails to adequately protect data security. Ideally, this could mean that nobody will be able to sell my personal health information to anybody else without incurring the huge fine. But the 563 pages of regulations are so complex, the effect may not do what Congress intended.

Will it work? Will these new protections be strong enough? I hope so. But frankly, I doubt it.

For one thing, we’ve seen too many hackers getting into big data bases. Nothing is that secure on the Internet. Besides, a $1.5 million fine for heatlh privacy offenders? That could be chump change, just the cost of doing business, for unscrupulous groups seeking to profit from your health data. And mine.

The woman in L.A. simply wanted a facelift. That’s all. But what she got was a nightmare – and a lesson for any of us who might be lured into the under-studied territory of cosmetic stem cell procedures.

Several years ago, the woman went to a California clinic that offered her a cosmetic procedure in which her own adult stem cells were harvested from her abdominal fat. (Adult stem cells are undifferentiated cells found amidst differentiated cells in tissues throughout the body; these cells can not only make many endless copies of themselves, they can also differentiate to yield some or all of the major cell types of the tissue from which they came.

At the clinic, doctors extracted from the woman’s fat stem cells that could turn into bone, cartilage or fat, according to a recent Scientific American article. Apparently, these cells were either mixed with a facial “filler” called calcium hydroxylapatite or injected into the same area as the filler. The filler can nudge stem cells to turn into bone.

Three months later, the woman couldn’t open her right eye without significant discomfort, and she heard a strange, clicking sound every time she opened and closed her eye.

Worried, she sought help from a different clinic, The Morrow Institute in Rancho Mirage, and a different doctor, cosmetic surgeon Dr. Allan Wu, chief scientific officer of the institute’s stem cell research lab.

In a telephone interview this week, Wu told me that, during a multi-hour procedure, the Morrow team extracted bits of bone from her eyelid and the area around her eye. The clicking sound, he said, probably came from these bone fragments hitting each other. Though the woman, whose name has not been released publicly, appears to be fine now, he said, other facelifts using isolated and concentrated stem cells alone may carry a risk of unintended bone growth and other potential long-term consequences.

The operation “took all of us a lot of work, a lot of sweating,” Wu told me. “Why? Because when you see bone and fat, or if you happen to see hair [in parts of the body where they shouldn’t be] you worry about a teratoma [a kind of tumor] that stem cells can form. We were all very worried – the question was, was this cancer surgery or cosmetic reconstruction?”

Luckily, it was the latter, Wu said, adding that his group supports the need for controlled studies and oversight by the U.S. Food and Drug Administration.

The FDA is trying to protect consumers against some untested cosmetic stem cell practices. Currently, the only FDA-approved stem cell-based products are blood-forming stem cells used for certain indications, such as bone marrow transplants in people with leukemia.

In the summer of 2010, the FDA requested an injunction in the U.S. District Court of the District of Columbia to stop a stem cell clinic called Regenerative Sciences from preparing its treatments. The company told me it has never performed any cosmetic procedures and only treats orthopedic conditions. The company was not involved in the case of the woman from L.A., according to Wu.

In July 2012, according to a report in the journal Nature, that court affirmed the right of the FDA to regulate therapies made from a patient’s own processed stem cells. The company argued that the cells it injects back are not significantly modified and that because of this, the procedures should be considered normal medical practice. The FDA argued that the cells are more than minimally manipulated.

Put differently, the court basically agreed with the FDA that the stem cells were manipulated enough that they should be considered drugs, and thus subject to pre-marketing approval. A blog post on Cell Therapy Blog saw things differently, believing that the court ruling was “just the beginning of what will be a long and interesting battle.”

Meanwhile, Regenerative Sciences is still in business. In Broomfield, CO, lead physician Christopher Centeno does a simplified stem cell orthopedic procedure at the Centeno-Schultz Clinic in which stem cells are harvested from bone marrow and re-injected into patients the same day; the company is also doing the more involved procedure with stem cell manipulation at its clinic in Grand Cayman.

More recently, the FDA has also been concerned about another stem cell company, Celltex in Houston. In a “warning letter” to the company in September, 2012, the FDA said that, following an inspection of the company’s plant in Sugarland, Texas, the agency found that the company’s processing of harvested adipose tissue did not meet the definition of “minimal manipulation” required and that the company’s promotion of its CellTex product causes the product to be considered a drug.

Not surprisingly, some consumer advocates are concerned. “The anti-aging market is where we see some of the strangest technologies and ingredients. Consumers are often surprised to learn how little oversight there is over cosmetic ingredients,” a spokesman for Environmental Working Group, a non-profit consumer watchdog group, told me.

The cosmetic stem cell industry is “huge,” though mostly outside the U.S., Stanford University cell biologist Christopher Scott, who also teaches ethics and law at the university’s Center for Biomedical Ethics, told me by phone this week. “Japan is a big practitioner, as are other Asian countries – China, India, and yes, also Europe. It’s a huge market.”

Scott noted that there are numerous legitimate studies underway exploring the potential of stem cells, but warned consumers against clinics that “overpromise” on their results and ones that, in pull-down menus on websites, offer stem cells for disparate conditions. “Cells are very different and the procedures are different. If a clinic offers a one size fits all fountain of youth, that’s a red flag.”

And don’t be fooled, he added, by clinics that tout testimonials from happy customers. “Testimonials are worthless as scientific evidence.”

Fixing the twin public health “epidemics” in this country — abuse of opioid painkillers by addicts and under-treatment of legitimate pain patients who often need those same drugs — will take time, a lot of creative thinking and a willingness to change dysfunctional government policies.

But there is one astonishingly simple step — a no-brainer, actually — that is immediately available and has been shown to reduce deaths from opioid overdoses. In fact, the city of Boston has already implemented this idea and is a model for the country. The utterly frustrating thing is that, so far, only 15 states and the District of Columbia have such programs — a far cry from what is needed.

The idea is what doctors call “harm reduction,” which means not necessarily trying to solve the root problem but to do things that make the problem less likely to be fatal.

The worst risk of opioid drugs (formerly called “narcotics”) is, obviously, fatal overdose. Opioids include heroin, oxycodone, methadone, fentanyl, codeine and morphine. Although reasonably safe when used properly, opioids do carry the risk of fatal overdose, whether used by a street addict or a pain patient.

The good news is that an antidote is available — injectable naloxone, which has been used in emergency rooms for years to reverse the potentially fatal breathing problems caused by an opioid overdose. It’s also available as a nasal spray called Narcan.

In both forms, naloxone rapidly knocks heroin and other opioids off opioid receptors. Naloxone brings about an instant, horrible withdrawal — but also saves the person’s life by restoring breathing. It has virtually no abuse potential and is considered very safe.

The chief flaw in the naloxone “rescue” idea is that, for the antidote to work, someone — conscious and functional — must be close by to administer the drug.

In Boston, deaths from overdoses among heroin abusers plunged after the city began distributing free Narcan kits to addicts in 2006, as the Boston Globe reported.

That success prompted the state Department of Public Health to run its own pilot program, which lists a number of places around the state where naloxone is available.

Nationwide, the Centers for Disease Control and Prevention reported in 2012 that community-based programs using naloxone have prevented the overdose deaths of 10,171 people since 1996. As of October 2010, there were at least 188 such programs operating in the U.S.

So encouraging are these results that the Food and Drug Administration is now considering ways to allow wider distribution of naloxone.

Few situations in medicine present such a clear take-home lesson: Naloxone could, and should, be made easily available to opioid abusers. It might also make sense for physicians who write opioid prescriptions for chronic pain patients to prescribe naloxone as well, with proper instructions for its use, so that patients could have an antidote on hand at home in case of overdose.

This might not prevent all opioid overdose deaths. But it would go a long way in the right direction.