Tag Archives: Food and Drug Administration

Who’s guarding the hen house?

money-pillsFrom the NY Times:

Addiction experts protested loudly when the Food and Drug Administration approved a powerful new opioid painkiller last month, saying that it would set off a wave of abuse much as OxyContin did when it first appeared.

An F.D.A. panel had earlier voted, 11 to 2, against approval of the drug, Zohydro, in part because unlike current versions of OxyContin, it is not made in a formulation designed to deter abuse.

Now a new issue is being raised about Zohydro. The drug will be manufactured by the same company, Alkermes, that makes a popular medication called Vivitrol, used to treat patients addicted to painkillers or alcohol.

In addition, the company provides financial support to a leading professional group that represents substance abuse experts, the American Society of Addiction Medicine.

Hmm. Let’s see,

  • they profit from a drug that will produce addiction;
  • they profit from a drug to treat addiction;
  • they manage to get their drug approved over a very lop-sided FDA panel objections;
  • they fund the American Society of Addiction Medicine (ASAM);
  • they funded the publication of a portion of the ASAM Patient Placement Criteria, which is the dominant framework for treatment placement decisions;
  • another of ASAM’s sponsors makes billions off of a medication with “near universal relapse” when they try to taper patients off it (It’s worth noting that the feds have also invested heavily in promoting Suboxone.);
  • ASAM engages in advocacy for the products these companies produce;
  • ASAM’s professional status and power places it in the position of conferring legitimacy and illegitimacy to treatments and policies;
  • people who questions these treatments and policies are dismissed as crackpots who reject empiricism.

Who makes policy?

[hat tip: Love First]

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With Rise Of Painkiller Abuse, A Closer Look At Heroin

English: Pre-war Bayer heroin bottle, original...

English: Pre-war Bayer heroin bottle, originally containing 5 grams of Heroin substance. (Photo credit: Wikipedia)

 

The number of people who had used heroin in the previous year increased between 2007 and 2012, from 373,000 to 669,000. Meanwhile, federal data from 2011 finds that nearly 80 percent of people who had used heroin in the past year had also previously abused prescription painkillers classified as opioids.

 

via With Rise Of Painkiller Abuse, A Closer Look At Heroin : NPR.

 

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A drug to treat cocaine addiction?

Structure of cocaine

Structure of cocaine (Photo credit: Wikipedia)

A recent study on the use of topiramate for cocaine addiction has been getting a lot of attention. Most of the coverage draws only from the researchers press release.

“Using an intent-to-treat analysis, the researchers found that topiramate was more efficacious than placebo at increasing the participants’ weekly proportion of cocaine nonuse days and in increasing the likelihood that participants would have cocaine-free weeks,” the university said Friday in a statement.

Similarly, Johnson’s team found a significant association between topiramate and both a decrease in craving for the drug and an improvement in the subjects’ overall level of functioning in comparison to a placebo.

Here are a few things you should know.

  1. What does “more efficacious than placebo” mean? It means that the number of days subjects did not use cocaine increased to 13.3% or 8.9%. (Depending on how you calculate it.) So, subjects still used cocaine 86.7% or 91.1% of days.
  2.  There a history of concerns about the manufacturer of the drug promoting off-label use of the drug.
  3. The lead researcher left his last post after losing a whistleblower lawsuit. One of his projects had been accused improperly charging the federal government for time spent on a study. He also attacked the character of the whistleblower.
  4. The lead researcher has a financial interest in topiramate.

I’m sure we’ll come up with effective drugs some day, but I’m skeptical that this is one of them.

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New drug bans

Different Marlboro Menthol cigarette boxes.

Different Marlboro Menthol cigarette boxes. (Photo credit: Wikipedia)

The European Union is banning menthol cigarettes.

Are legalization advocates troubled by this? I’m asking sincerely.

Same thing with K2 and Spice. They were banned in Michigan earlier this year, without protest.

At what point does the conversation turn to the issue of eliminating restrictions on access to prescription drugs? If recreational use of pot or heroin (I recognize that a lot of pot legalization advocates do not advocate legalizing all drugs.) are legalized and regulated, why not fentanyl and vicodin? What principles or values should guide these decisions?

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What should we think about e-cigarettes?

k300_flavors_fruitsMotherlode notes a trend in e-cigarettes and is concerned:

I was standing outside our neighborhood ice cream shop one recent evening when I noticed a plume of smoke rise above a gaggle of teenagers waiting in line ahead of me.

“Wow,” I thought, “that takes some serious chutzpah.” These kids were smoking in public without the fear of getting caught.

A few minutes later, I realized that it wasn’t actually smoke coming out of their mouths; it was vapor, being inhaled and exhaled from battery-operated electronic cigarettes.

E-cigs are devices that vaporize an addictive nicotine-laced liquid solution into an aerosol mist that simulates the act of tobacco smoking. Also known as “personal vaporizers” and “electronic nicotine delivery systems,” e-cigs are sold in trendy shops and are increasingly turning up in bars, clubs, workplaces and other spots where traditional tobacco cigarettes have long been outlawed.

As a mother, I find this terribly distressing.

I’ve spent years telling my children that smoking can kill you. And thanks to decades of sensible public health policies — including laws banning cigarette advertising and smoking in public places — as well as brutally graphic antismoking marketing campaigns, my 15- and 21-year-old kids have grown up in a culture in which puffing on cigarettes is stigmatized. Last year, cigarette smoking among teens fell to a record low.

Now, it seems, all that progress is about to vaporize. “Smoking,” at least in the form of vaping, is becoming cool again. This week, the Centers for Disease Control reported that 1.8 million middle- and high-school students said they had tried e-cigarettes in 2012 — double the number from the previous year.

Kleiman urges restraint in regulating e-cigarettes:

The FDA’s desire to have enough authority to require e-cigarette sellers to manufacture them properly and label them accurately, to limit marketing aimed at minors, and to be able to force the removal of unsafe product from the market, seems quite reasonable. What’s not reasonable, and what is likely to be bad, on balance, for health, is the idea that anything that delivers nicotine vapor should have the same rules applied to it as an actual cigarette.

At the same time, he acknowledges the unknowable:

None of this is simple or straightforward. I can imagine myself, five years from now, bitterly regretting not having spotted the e-cigarette menace before it got out of control. But regulations can do harm as well as good, and what I’m not hearing right now is much willingness to think carefully and proceed with caution. The principle of aggregate harm minimization, net of benefits (and nicotine does have benefits, including at least a temporary cognitive boost) still seems to me the right approach, for nicotine no less than for cannabis or cocaine. Unless and until someone can point to demonstrated and serious risks, rather than speculative ones, e-cigarettes ought to be thought of mostly as a part of the solution rather than as a part of the problem.

What does Kleiman mean by part of the solution? A recent study found that e-cigarettes outperformed traditional nicotine replacement for smokers trying to quit:

the New Zealand government funded a head-to-head comparison study. Chris Bullen and his colleagues at the National Institute for Health Innovation in Auckland gave e-cigarettes to 289 smokers who were trying to quit. A separate group of 295 people were given nicotine patches, while 73 received dummy nicotine-free e-cigarettes.

Six months later, the team asked participants if their attempts to quit had been a success. Those who had used the nicotine e-cigarettes had the highest success rate: 7.3 per cent had managed to stay away from tobacco. Of the nicotine patch users, 5.8 per cent had quit. And of those taking the placebo around 4 per cent were successful.

“The quitting rates were about 25 per cent better than patches for the e-cigarettes, but statistically we’re more confident with saying that they were comparable, rather than superior,” says Bullen.

Vaportrim-Fruit-Flavored-PuffsWhile we’re trying to understand e-cigarettes, manufacturers are embedding themselves in our culture. In the U.S., it’s been using b-list celebrities, appealing to current smokers’ sense of oppression and marketing them as a diet aid. In the U.K., they are using sport:

Merthyr Town Football Club is to rename its ground the Cigg-e Stadium after its sponsor, an electronic cigarette firm.

The Southern League club has signed a three-year deal with the company which has just opened a shop in the town.

 

 

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Suboxone Strategy: Protecting Patients Or Profits?

Reckitt Benckiser

Reckitt Benckiser (Photo credit: Wikipedia)

I’m a little late on posting this one, but it still seems worth sharing.

Reckitt Benckiser has decided to pull Suboxone tablets from the market. Why? It’s an evidence-based decision and an expression of their desire to be a good corporate citizen and their concern for children.

Late last month, Reckitt Benckiser created a stir by unexpectedly announcing that its Suboxone tablet for treating opioid dependence will be withdrawn from the US market sometime over the next six months. The reason? The drugmaker, which is based in the UK and actually best known for household cleaning products, expressed concern that children could be accidentally harmed by easy access to tablets that are marketed in bottles.

In making its case, Reckitt cited specially commissioned data showing “consistently and significantly higher rates of accidental unsupervised pediatric exposure” with Suboxone tablets than with Suboxone Film, a newer version of its drug that dissolves under the tongue and can only be accessed by tearing open individual blister packaging. Specifically, the rates for Suboxone tablets were roughly eight times greater (read here).

What’s the big business picture?

To generic drug makers, some physicians and Wall Street analysts, however, the moves amounted to a transparent one-two punch designed to delay lower-cost generic tablets from reaching the market. The patent on Suboxone tablets, in fact, expired two years ago, while patent on Suboxone Film expires in 2022, according to the Reckitt spokesman. “If Reckitt is so concerned about safety,” says one industry source, who asked not to be named, “then why not take the tablets off the market right away? Their tablets are still on the market without blister packing, which they themselves say is unsafe.”

Meanwhile, Reckitt has gradually raised the price of Suboxone Tablets in order to switch patients. The current wholesale average cost (WAC) for a bottle of 30 Suboxone Tablets is $161.70 for the 2 mg dose and $289.80 for the 8 mg dose, according to the Reckitt spokesman. In July, however, the same bottle of the 2 mg dose cost $140.00 and the 8 mg WAC was $252.00, industry sources say. Meanwhile, Suboxone film pricing has held steady: WAC pricing for a carton of 30 Suboxone Film strips remains $117.85 for the 2 mg dose and $211.15 for the 8 mg dose.

More recently, sales of Suboxone tablets fell 19 percent between August 2011 and August 2012, to $658.5 million, according to IMS Health, while sales of Suboxone film doubled to more than $764 million during the same period. “They are (removing the tablets) because generics are expected in 2013 on the tablet,” says Sanford Bernstein analyst Ronny Gal. “The critical question is whether their argument that film is always safer for children will convince FDA not to approve any oral solid generic.”

For these reasons, the back-to-back announcements have been met with outrage. “They have known for years that a generic tablet could destroy their golden calf — and Suboxone is Reckitt Benckiser, from an earnings standpoint. If they do not destroy the tablet, it destroys them,” Jeff Junig, a psychiatrist at the University of Wisconsin Oshkosh Student Health Service and an assistant clinical professor of Psychiatry at the Medical College of Wisconsin, wrote in a letter to Alcoholism & Drug Abuse Weekly.

“I’m sure I sound… paranoid? Cynical?,” wrote Junig, who also authors a blog about Suboxone. “But it is so frustrating when you see marketing trump science. This will discourage generics from making buprenorphine, which will keep the price high, which will cause deaths. Shame on them.”

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They’ve got hope for something. But, what?

Stimulant maintenance therapy did not work 😦

This study did not find a significant main effect of modafinil on the rate or duration of cocaine use among cocaine-dependent patients.

Now they decide to polish the turd:

Although these results are disappointing, we did find that modafinil-treated patients had nonsignificantly higher odds of attaining abstinence across all of the study time points, and those treated with 400 mg/day had significantly greater odds of attaining abstinence (p = .04) at the end of their 8-week medication trial (Visit 24). There was also a significant difference (p = .02) in the OR for abstinence at the final follow-up visit, suggesting the possibility that modafinil facilitated delayed clinical improvement that was not captured by our 8-week study design.

Back to reality:

Despite its ability to blunt cocaine-induced euphoria in three controlled human laboratory studies ( [Dackis et al., 2003][Hart et al., 2008] and [Malcolm et al., 2006]), modafinil did not show overall success in this outpatient clinical trial.

Maybe these people are just too tough:

It is important to note that all of the patients in this study tested positive for cocaine at baseline. It is well established that patients who test positive for cocaine at study start have extremely poor clinical outcomes when compared with those who are able to produce a cocaine-negative urine sample ( [Ahmadi et al., 2009],[Kampman et al., 2001][Patkar et al., 2002] and [Poling et al., 2007]). The reason for this finding is unclear, but it probably stems from greater addiction severity, less motivation for recovery, or both of these clinical features.

There will be evidence, dammit!

Despite our negative study, we believe it is premature to dismiss modafinil as a potential treatment for cocaine dependence.

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