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Jack Sisson's Life Ethics Blog

We must find new ways through many ethical issues, especially regarding bioethics, medical ethics, and criminal justice. Jack Sisson's 'Life Ethics' blog focuses on numerous areas of concern, including the philosophical and ethical dilemmas surrounding stem-cell research, abortion, medical research, and health care.

 

From Ring of Fire:

Last week, a panel of the United States Court of Appeals reversed the conviction of a drug company employee who encouraged doctors to prescribe a dangerous drug to inappropriate populations and for unapproved diseases.  This is a closely-watched decision that has a lot to say about companies’ responsibilities to doctors and patients.  If the decision stands, it could affect the safety of patients across the United States.

Alfred Caronia was a sales representative for a small drug company, Orphan Medical.  Orphan sold a drug called Xyrem, whose active ingredient is known as gamma-hydroxybutyrate or GHB.  GHB, which can be a highly dangerous drug, is also known as “the date rape drug” because of its use in committing sexual assaults.  In fact, the FDA believed Xyrem was so dangerous, it could only be distributed through a single pharmacy in Missouri.

Nevertheless, Xyrem was approved for sale in the United States, but only for very specific uses: for narcolepsy patients who experienced weak or paralyzed muscles, or who experienced excessive daytime sleepiness.

Mr. Caronia and Orphan were determined to increase sales of Xyrem, and Mr. Caronia’s salary depended almost exclusively on his sales record.  According to the facts in the case, Mr. Caronia’s numbers were among the worst of all Orphan sales representatives. A drug company’s sales representatives make their living by encouraging doctors to prescribe drugs to their patients.  In this case, Mr. Caronia actually had Orphan hire a medical doctor with experience in prescribing Xyrem to work with him in talking to other doctors.

The government became aware that Mr. Caronia was encouraging doctors to prescribe Xyrem for uses other than narcolepsy.  Using an informant, the government was able to tape Mr. Caronia encouraging prescriptions of Xyrem for chronic muscle disorders, chronic pain, fibromyalgia, insomnia, and other disorders outside the drug’s approval.  He also explained to doctors that the drug could be used in children and the elderly, which were age groups not approved to receive the drug.

It is a crime to sell a misbranded drug in interstate commerce, and in 2008, a jury convicted Mr. Caronia of conspiracy to introduce a misbranded drug into interstate commerce in violation of the federal drug laws.  Mr. Caronia was sentenced to one year of probation and 100 hours of community service.

It appears to have been the government’s theory at the trial that by making misleading or false statements about the safety and effectiveness of Xyrem, Mr. Caronia caused Xyrem to be sold in a way that made it misbranded.  Mr. Caronia appealed his conviction, and last week, the U.S. Court of Appeals overturned it.

On appeal, a 2-1 panel of the Second Circuit Court of Appeals divided over whether the conviction was lawful.  The majority argued that Mr. Caronia’s First Amendment speech rights were at issue, and that he had a right to engage in the speech of his choosing — even if it was directed toward the promotion of a drug for an unapproved purpose.  In the majority’s view, Mr. Caronia’s free speech rights trumped any concern for patient safety that might be served by his conviction because the government had other ways to protect patients from the use of an unapproved drug.

The dissenting judge rejected the First Amendment rationale, reasoning that speech is an essential element of many crimes, such as conspiracy, attempt, antitrust violations, and others.  Further, if the government could not prosecute individuals for making statements intended to encourage the unsafe use of drugs, patients would be at risk and the government’s whole scheme of drug regulation would be upset.

This decision could have a big impact on patient safety.  There was no dispute among the judges that Mr. Caronia clearly engaged in the promotion of Xyrem, the “date rape drug,” for dangerous, unapproved uses — with a direct, personal financial interest in such promotion.  The difference came down to whether Mr. Caronia had a right to do so under the First Amendment.

Because of the unique nature of their business, with huge upfront costs and a guaranteed but time-limited monopoly on the sale of their products, drug companies have powerful incentives to maximize their sales before patents run out.  That is why the federal government needs to carefully regulate their conduct.  This decision is a disappointment for those concerned with patient safety.  Drug sales representatives are low-level employees, often with little or no medical training, who have only one function: to push pills.  Their employers, some of the largest corporations in the world, have vast financial resources and are easily able to absorb most penalties if they are caught selling misbranded drugs.  The criminal prosecution of individual drug sales representatives provides a powerful deterrent to what would otherwise be completely immunized behavior.  If the Caronia decision stands, it will give other sales reps license to say whatever is necessary to boost sales and profits at the expense of patient safety.

At this time, it too early to say whether the government will appeal the Second Circuit’s decision to the U.S. Supreme Court.  The Supreme Court has taken many high-profile pharmaceuticals cases in recent years.  If it takes this case, Mr. Caronia’s conviction could be reinstated.

Link to Ring of Fire.

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From Health Affairs Blog:

From fake Avastin to contaminated generic Lipitor, every month Americans are becoming more aware about the dangers of lethal products they might be unlucky enough to take. With attentive regulators and competent companies, most incidents of dangerous drugs in US pass without significant harm, but when tainted steroid injections were recently distributed to thousands of patients, 36 died and over 500 suffered painful conditions.

The tragedy for those Americans harmed is multiplied at least a thousand fold in the carnage wreaked in developing countries. Perhaps 100,000 people die every year from dangerous medicines and by most estimates the situation is deteriorating. To put it simply we are losing the global fight against bad medicines.

Efforts are being made by law enforcement officials.  Eighty-two million doses of counterfeit drugs in Africa were seized by numerous national authorities, comprising about $40 million worth of antimalarials, antibiotics, cough medicines, contraceptive pills, and fertility treatments.

Why Substandard Drugs Are Even Worse Than Counterfeits

The problem is that such crackdowns tend to focus on counterfeit drugs, deliberately falsified by criminal networks. Such efforts are obviously warranted, but probably a much greater public health threat, as the tainted steroid injections demonstrated, is substandard drugs that are the result of shoddy manufacturing and handling – or perhaps worse, deliberate corner-cutting.

In poor countries, an astonishing number of bad drugs reach patients through legitimate supply chains and even donor programs underwritten by U.S. and European taxpayers. Substandard drugs tend to have a suboptimal — but non-zero — dose of active pharmaceutical ingredient. Such low-dose products do not effectively treat individual patients, yet they are more likely to rapidly increase population-level resistance than fake drugs with no real ingredients. Resistance can even be spread to effective drugs, undermining entire product categories. As a result substandards may well be worse than deliberately counterfeited drugs containing no active ingredient.

Donor governments and U.N. agencies do take measures to ensure the quality of medicine they procure. Most governments or multilateral donors, for example, will only purchase for aid programs medicines that have been approved by a stringent regulatory authority — such as the U.S. Food and Drug Administration or its European equivalent — or by the World Health Organization (WHO). But this isn’t enough to safeguard patients against poor quality drugs.

As I’ve demonstrated through previous research, off-the-shelf drugs made by Chinese and, to a lesser extent, Indian manufacturers tend to perform inconsistently on quality tests. In one study, more than 15 percent of the Chinese drugs we collected that were approved by the WHO failed to include adequate amounts of active pharmaceutical ingredient.

Our latest paper, in Malaria World Journal, reinforces these findings. Over 97 per cent of products made by manufacturers approved by the WHO had the correct active pharmaceutical ingredient. Among manufacturers not approved by the WHO, the percentage drops to about 87 per cent.

Worse still, some of the drugs we tested had been bought through Western donor programs, funded by taxpayers, and steered through aid programs to African markets. Some of these drugs may have degraded through bad storage, but many were just badly manufactured, perhaps to cut corners to lower costs and increase profits. After all, once a manufacturer has obtained quality certification, it is relatively easy to sell the drug at a lower quality in countries with weak regulations.

Continue reading.

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If you're a repeat visitor to Jack Sisson's Life Ethics or Traumatic Brain Injury blogs, you'll notice some changes over the next several weeks. We're bringing the "look and feel" of the two blogs into alignment with the rest of Jack's site, which recently underwent a complete overhaul. At first the changes will be superficial: background colors, fonts, and so on. When we're done, the menu across the top will be remade, and repositioned down the left-hand side. The sidebar menu on the right side will change significantly, and perhaps be removed altogether.

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