Cash, sexual favors and drugs

money-pillsCash, sexual favors and drugs. We’re not talking about a dope house.

Some people (and companies) never learn:

…last week, UK pharma firm GlaxoSmithKline admitted that Chinese doctors were bribed by its execs with cash and sexual favours in return for prescribing the company’s drugs. That coincided with rival AstraZeneca having its Shanghai office raided by police – all of which is jolly inconvenient, as Astra faces the City this week to unveil its interim results.

Some investors ponder whether bribery is a wider problem than has yet emerged, and if Chinese authorities are deliberately targeting foreign firms.

Maybe, but critics of the UK companies also point to GSK’s $3bn fine last year for bribing US doctors, plus Astra’s indictment in Serbia on similar charges, as well as an admission in its annual report about “investigating indications of inappropriate conduct in certain countries, including China”.

Why is this relevant here?

Well, last year GSK, among other things, admitted to illegally marketing Wellbutrin as an addiction treatment. They are a current partner with NIDA on developing a nicotine vaccine.

As for AstraZeneca, they are a new partner with NIDA on developing new addiction treatment medications.

In a related post, Alan Frances argues that congress needs to fix the U. S. mental health system.

On Pharma:

Third, Big Pharma needs to be tamed — just as twenty years ago, Congress tamed Big Tobacco. Drug company marketing consists of nothing more than misleading disease mongering — selling diagnoses to peddle pills to people who don’t need them. If it has the political will to take the following steps, Congress can easily end Pharma’s hijacking of medical care. No more direct-to-consumer advertising of drugs — a privilege Pharma enjoys only in the US. No more misleading marketing to doctors cloaked in the sheep’s clothing of ‘education’. No more financial contributions turning consumer advocacy groups into extenders of company lobbying. No more ‘research’ guided by the marketing efforts to enhance patent life and stretch indications, rather than aiming for real breakthroughs. No more ghost written papers by thought leaders who mouth party line. No more monopoly pricing power because government is prohibited from bargaining. And no more revolving door politicians drifting back and forth from government to cushy Pharma jobs.

On overdoses:

Seventh, Congress should attend to the catastrophe that more people now die from overdoses of prescription than street drugs. High flying prescribers need to be brought to ground with strict monitoring, professional discipline, and public shaming. And real-time computerized control could contain loose drug dispensing. If Visa can put an advance stop on a suspicious $100 purchase, we can develop a proactive check that a prescription makes sense before filling it. Cooperative FDA and DEA scrutiny of drug company marketing practices and distribution methods would reduce the current free availability of lethal narcotics. We are fighting a drug war against the cartels that we cannot possibly win and haven’t yet begun a war against the inappropriate use of prescription drugs that we could not possibly lose.

Also a couple of points on Pharma’s diagnostic fuel.

On the DSM:

First, the diagnostic system in psychiatry is broken and can’t be fixed internally by the American Psychiatric Association — which currently holds the monopoly. DSM-5 has fanned the flames of diagnostic inflation with definitions that turn everyday life problems into mental disorder — harming the misidentified ‘patients’ and costing the economy billions of dollars. Psychiatric diagnosis has become too important (in decisions determining workman’s comp, disability, VA benefits, school services, custody, criminal responsibility, preventive detention, and the ability to adopt a child, fly a plane, or buy a gun) to be left to one small professional association

Psychiatric diagnosis is too much a part of public policy to be left exclusively in the hands of the psychiatrists. Experts in psychiatry have no expertise in how their diagnostic decisions will affect public health, public welfare, the allocation of resources, and the health of the economy. Congress should set up an agency to ensure much more careful vetting of risks and benefits.

On inflated prevelance estimates:

Sixth, Congress should investigate the CDC’s fatally flawed method for determining rates of mental disorder. CDC has a systematic bias toward over-estimating the disorder rates in the healthy and ignoring the needs of the really sick. Its data gathering relies on telephone contacts conducted by lay interviewers who cannot possibly distinguish clinically significant mental disorder from everyday symptoms that are part of the human condition. The wild instability and elasticity of the reported prevalences is proof positive they should be discounted; not taken as credible indication our society is getting sicker. Epidemiological attention should focus instead on the extent and correlates of the more severe mental disorders currently being neglected.

GlaxoSmithKline’s corruption

GlaxoSmithKline
(Photo credit: Ian Wilson)

The details are simultaneously exactly what you’d expect and shocking.

And some people wonder why we’re reluctant to embrace the latest and greatest pharmacological fad. Keep all of this in mind next time someone suggests that medicalizing addiction treatment will improve professionalism, ethics and reliance on scientific evidence.

Sham advisory boards:

Glaxo also used sham advisory boards and speakers at lavish resorts to promote depression drug Wellbutrin as an option for weight loss and a remedy for sexual dysfunction and substance addiction, according to the government. Customers were urged to use higher-than-approved dosages, the government said.

Phony continuing education programs:

GSK paid millions to doctors to promote the drug off-label during meetings sometimes held at swanky resorts, the government said. The company relied on pharmaceutical sales reps, “sham advisory boards,” and continuing medical education programs that appeared independent but were not.

Misleading doctors:

The company went to extreme lengths to promote the drugs, such as distributing a misleading medical journal article and providing doctors with meals and spa treatments that amounted to illegal kickbacks, prosecutors said.

Bribing doctors:

“GSK’s sales force bribed physicians to prescribe GSK products using every imaginable form of high priced entertainment, from Hawaiian vacations to paying doctors millions of dollars to go on speaking tours to a European pheasant hunt to tickets to Madonna concerts, and this is just to name a few,” said Carmin M. Ortiz, U.S.attorney in Massachusetts.

Widespread:

Crimes and civil violations like those in the GlaxoSmithKline case have been widespread in the pharmaceutical industry and have produced a series of case with hefty fines. One reason some have said the industry regards the fines as simply a cost of doing business is because aggressively promoting drugs to doctors for uses not officially approved — including inducing other doctors to praise the drugs to colleagues at meetings — has quickly turned numerous drugs from mediocre sellers into blockbusters, with more than $1 billion in annual sales.

Stories have noted that Pfizer agreed to a $2.3 billion settlement in 2009. Also, Johnson & Johnson settled with Arkansas for $1.2 billion for several violations, including:

…for not disclosing the risks of the antipsychotic Risperdal.

Withholding data on Paxil:

GSK allegedly participated in the publishing of medical journal articles that stated paroxetine was effective in patients under 18, when, in fact, the data showed that the opposite was true. At the same time, the company withheld study data in from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18, according to a press release from the Justice Department.

Kept safety issues secret:

…the company kept secret data on raised cardiovascular effects.

An exciting time for pharma

photo credit: carbonNYC

Ugh!

This Join Together article reads like a ad for pharma:

Many people struggling with alcohol dependence who could benefit from medication are not receiving it, according to an expert who spoke at the recent American Psychiatric Association Annual Meeting.

“Antidepressant prescribing is 100 to 200 times as great as prescriptions for medications approved to treat alcohol dependence, despite the fact that the prevalence of disorders for which antidepressants are prescribed—major and minor depression and anxiety disorders—is only two to three times that of alcohol dependence,” says Henry Kranzler, MD, Professor of Psychiatry at the Treatment Research Center at the University of Pennsylvania and the Philadelphia VA Medical Center.

Perhaps I’m the Wrong Tool by Tall Jerome

There’s plenty of room for debate about whether high antidepressant prescribing rates represent money well spent or good medicine, but I’ve covered that before. (See below)

He expresses some enthusiasm about Topamax and then touts a new drug coming from Denmark:

Lundbeck, a Danish pharmaceutical company, has submitted an application for approval by the European Medicines Agency of the medication nalmefene to be used on an as-needed basis to reduce heavy drinking, according to Dr. Kranzler. “This is a novel approach and could have an impact on treatment throughout the European Union and possibly the U.S.,” he adds.

Here’s what a disinterested trade publication had to say about the drug [emphasis mine]:

Danish pharmaceutical company H. Lundbeck A/S yesterday unveiled clinical data on its potential blockbuster drug nalmefene at the 2012 European Congress of Psychiatry clinical in Prague. While Lundbeck and its Finnish partner Biotie Therapeutics Corp. from Turku underline an impressive 66% reduction in total alcohol consumption, a closer look at placebo data is disconcerting. In three placebo-controlled Phase III studies, the drug with the trade name Selincro was given to heavy drinkers who also were given medical advice about their drinking habits. Selincro aims at eliminating the brain’s pleasure response to drinking. After six months, numbers of heavy drinking days (total alcohol consumption) in the first study dropped from 19 to 7 (84g to 30g) in the drug arm, and from 20 to 10 (85g to 43g) in the placebo arm. The numbers of the second study were less convincing and – even worse – in the third study the drug arm barely outperformed the placebo. Nevertheless Biotie-CEO Timo Veromaa thinks that “Selincro has the potential to transform the way alcohol dependence is managed by both patients and physicians.”

Too bad the Join Together article didn’t include a commercial interest disclosure statement* and note that he and/or his projects have received money from the manufacturers of Topamax and nalmefene.

I believe that medications may play a helpful role in the future, but I’m underwhelmed by the current stable of drugs and troubled that so much energy gets put into promoting expensive drugs of dubious value.

This is an exciting time in the treatment of alcoholism, because the field of medication treatment for alcohol dependence is expanding into the arena of personalized medicine, he says.

I’d love to see helpful drugs come along and I think a lot of these docs and researchers have good motives, but they have one tool (the prescription pad) and they seem to consistently oversell it.

* The ASAM event disclosure lists that Dr. Kranzler and/or his projects have recieved money from Alkermes, Roche, Pfizer, Lundbeck, Lilly, Eli Lilly, Janssen, Schering Plough, GlaxoSmithKline, Abbott and Johnson & Johnson. ProPublica does not list him at all. Possible explanations are here.

Addiction diagnoses to rise

I’ve posted before about problems with the proposed approach to addiction in the DSM-5.

These changes were intended to clear up language problems, specifically the conflation of dependence and addiction leading to “false positives” for addiction. Looks like the DSM-5 is causing its own language problems before it’s even adopted. [emphasis mine]

Many scholars believe that the new manual will increase addiction rates. A study by Australian researchers found, for example, that about 60 percent more people would be considered addicted to alcohol under the new manual’s standards. Association officials expressed doubt, however, that the expanded addiction definitions would sharply increase the number of new patients, and they said that identifying abusers sooner could prevent serious complications and expensive hospitalizations.

Further, I’m pretty skeptical of the suggestion that the current abuse diagnostic category constitutes a medical illness requiring any kind of medical treatment, and they are looking forward to the new criteria being more inclusive and being classified as having form of addiction?

The article demonstrates that the inevitable slide into viewing low-severity AOD problems as the first stage of addiction:

“We can treat them earlier,” said Dr. Charles P. O’Brien, a professor of psychiatry at the University of Pennsylvania and the head of the group of researchers devising the manual’s new addiction standards. “And we can stop them from getting to the point where they’re going to need really expensive stuff like liver transplants.”

On top of this, conflicts of interest are being exposed. It’s pretty clear that this would be a major boon for drug companies, particularly with the Affordable Care Act simultaneously increasing access to healthcare for people with AOD problems and increasing physician responsibility to treat AOD problems that they are poorly equipped to address.

Some critics of the new manual have said that it has been tainted by researchers’ ties to pharmaceutical companies.

“The ties between the D.S.M. panel members and the pharmaceutical industry are so extensive that there is the real risk of corrupting the public health mission of the manual,” said Dr. Lisa Cosgrove, a fellow at the Edmond J. Safra Center for Ethics at Harvard, who published a study in March that said two-thirds of the manual’s advisory task force members reported ties to the pharmaceutical industry or other financial conflicts of interest.

Dr. Scully, the association’s chief, said the group had required researchers involved with writing the manual to disclose more about financial conflicts of interest than was previously required.

Dr. O’Brien, who led the addiction working group, has been a consultant for several pharmaceutical companies, including Pfizer, GlaxoSmithKline and Sanofi-Aventis, all of which make drugs marketed to combat addiction.

He has also worked extensively as a paid consultant for Alkermes, a pharmaceutical company, studying a drug, Vivitrol, that combats alcohol and heroin addiction by preventing craving. He was the driving force behind adding “craving” to the new manual’s list of recognized symptoms of addiction.

“I’m quite proud to have played a role, because I know that craving plays such an important role in addiction,” Dr. O’Brien said, adding that he had never made any money from the sale of drugs that treat craving.

Dr. Howard B. Moss, associate director for clinical and translational research at the National Institute on Alcohol Abuse and Alcoholism, in Bethesda, Md., described opposition from many researchers to adding “craving” as a symptom of addiction. He added that he quit the group working on the addiction chapter partly out of frustration with what he described as a lack of scientific basis in the decision making.

“The more people diagnosed with cravings,” Dr. Moss said, “the more sales of anticraving drugs like Vivitrol or naltrexone.”