Providing patients with promising experimental therapy or ruining clinical trials?

Posted on: October 31, 2009  |   Author: Jessica
Filed Under: Bioethics, Drug & Device   |   Leave a Comment

Ninety percent of clinicians in a recent online survey believed that ignoring certain entry criteria for clinical trials was acceptable if the clinician believes that the patient will benefit from the trial. A number of clinicians described under what circumstances they would bend the rules. Downplaying a substance abuse history, altering medical records, and artificially improving an otherwise poor kidney function test are all examples of protocol violations that some clinicians found acceptable under the right circumstances.

All of the protocol violations were presumably made because the doctors felt that they were acting in the best interests of their individual patients. However, the purpose of clinical trials is not to improve the outcomes of individual patients, they are to determine the safety and effectiveness of an experimental drug or treatment. (To learn more about clinical trials see clinicaltrials.gov)

What does this mean for clinical trials? Do researchers need to focus on improving clinical trial designs so that clinicians do not feel conflicted between their commitment to their patient and the research? If so many clinicians seem willing to break protocol, can the results of the trials even be trusted?

The New York Times, October 29, 2009.

Tough Choices: A Blurb About the Difficult Choices Facing Many Couples in Their Quest for Fertility

Posted on: October 31, 2009  |   Author: David
Filed Under: Drug & Device, HMOs & Health Plans, Health Information, Hospitals & Health Systems, Insurers/Payors, Technology   |   Leave a Comment

It may be one of the hardest decisions an expectant parent would have to make: Reduce the number of fetuses you are carrying or risk losing them all.

Sadly, that is exactly the decision Thomas and Amanda Stansel had to make. After undergoing the popular process of intrauterine insemination in which sperm is injected into Mrs. Stansel’s uterus following hormone injections, Mrs. Stansel received shocking news – she was carrying not one, not two, but six fetuses. However, the Stansel’s excitement was soon crushed when their fertility doctor gave them some additional startling news. Due to the increase in fetuses, the likelihood of delivering six healthy infants was near zero. To save some, he recommended reduction – through a process known as “selective reduction.” The Stansels decided not to reduce, instead relying on their faith to protect them and in August, Mrs. Stansel gave birth to all six babies. Unfortunately, at 14 weeks premature, all weighed in at roughly one pound. The hospital fought valiantly, but three babies died within two weeks. A few months later, another was lost. The two babies remaining continue to struggle, still attached to ventilators and feeding tubes and under constant care in the hospital neonatal intensive care unit.

For couples having difficulties becoming pregnant, there are several options available. First, most doctors recommend utilizing low-potency fertility drugs in order to stimulate the process. If unsuccessful, the next step is intrauterine insemination with hormone injections or in vitro fertilization. This decision is often influenced by two related factors: insurance and costs. The cost of in vitro fertilization costs between $12,000 and $25,000 while intrauterine insemination only costs $2,000 to $3,000 per attempt. As such, many insurance companies will cover multiple rounds of intrauterine insemination before one round of in vitro fertilization. The preference though, is not without drawbacks. Intrauterine insemination, while front-end cheaper, can present significant problems. Excessive hormone injections can lead to an overstimulation of the ovaries which in turn can lead to the increase in probability of having multiples. In fact, the Centers for Disease Control and Prevention supported this theory when it found that the intrauterine insemination process was more likely to result in multiples than in vitro fertilization. And with increased multiples, come increased risks, especially with premature births which carry the risk of long-term complications and disabilities. Multiples, like the Stansel babies, who arrive early, require the highest level of acute care for a longer time than any other patients. This can add up to astronomical financial hardships in the long-run. In addition to money, multiples with increased risks of complications can put families in very difficult decision like the one faced by Thomas and Amanda Stansel- whether to abide by religious beliefs against the perception of abortion or a doctor’s recommendations to reduce.

The current position taken by insurance companies is baffling. Intrauterine insemination is largely undocumented today, but has been shown to be less successful and more dangerous (with respect to increasing risks for premature multiples) than in vitro fertilization. The main upside, cost. Due to the less invasive nature of intrauterine insemination there is a significant cost difference between the two procedures leading many insurance companies to favor the treatment. In doing so, insurance companies may be overlooking two major issues. One, as this procedure becomes more popular, the costs associated with premature multiples will also grow- likely at a much higher rate than the cost of the initial fertility treatment. Second, many couples attempting to start a family do not understand the possible consequences of their actions – the psychological and financial considerations of having a tragic result. Insurance companies have long acted as a gatekeeper in providing medical treatment and should take a second look at their current preference towards intrauterine insemination.

The New York Times, October 11, 2009.

Generic Drug Patent Settlements

Posted on: October 23, 2009  |   Author: Ali
Filed Under: Drug & Device, Health I.P., Life Sciences, Other, Tax & Finance   |   Leave a Comment

Generally, most patent lawsuits are resolved when the accused infringer agrees to pay money to the patent rights-holder.  However, in patent infringement suits involving generic pharmaceutical manufacturers these agreements sometimes follow a different path.  Occasionally, the patent-holder will give the generic drug manufacturer money to delay the release of the generic drug (the Federal Trade Commission calls this a “pay for delay” deal).

These payments ultimately delay the introduction of generic drugs and FTC Chairman Jon Leibowitz estimates that “pay for delay” deals cost consumers, insurance companies, and the federal government spends an additional $3.5 billion each year (the drug manufacturers dispute this estimate).

The first example of this kind of deal was in 1994 when Bristol-Myers Squibb paid Schein Pharmaceutical $290 million to delay the sale of a generic version of Bristol’s Buspar, anti-anxiety drug.  Recently, drug purchasers, including CVS Caremark Corp. and Rite Aid Corp., challenged an agreement between Bayer AG and Barr Pharmaceuticals Inc. where Bayer paid Barr to delay producing a generic version of Cipro, an antibiotic drug.

In July, the Department of Justice stated that these kinds of settlements are “presumptively unlawful”.  Last week, the senate judiciary committee voted 12 to 7 to forbid these deals.  President Obama also supports a ban.

ABC News, October 15, 2009; Wall Street Journal, July 6, 2009; PatentlyO, October 16, 2009.

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