FDA Gets a Little Power
September 28, 2007
Congress took a step in the right direction by passing a bill giving the FDA more money and some new powers. The FDA can now force a pharmaceutical company to change its label [If you didn't know, the FDA couldn't force a company to change its label]. The bill also grants the agency the power to require drug makers to undertake clinical trials of approved medicines or Phase 4 studies. Pharmaceutical manufacturers will now be required to post the results of all clinical trials involving approved medicines.
Popularity: 30% [?]
A Little Introspection is Good for the Soul
September 28, 2007
The FDA’s incompetence is outed in a report by the Department of Health and Human Service released today. The DHHS confirms the Institute of Medicine’s earlier criticism of the FDA.
It is apparent from the report that the FDA is overwhelmed and cannot deal with the volume of clinical trials. The F.D.A. has 200 inspectors, some of whom audit clinical trials part time, to police an estimated 350,000 testing sites.
Relying on the pharmaceutical companies to police their own clinical trials is like allowing the proverbial fox to guard the hen house.
Popularity: 31% [?]
Clinical Trial - A Very Simple Analysis of a Complex Issue
September 19, 2007
The recent death of a patient participating in the Targeted Genetic’s Phase I/II trial of tgAAC94, a potential treatment for rheumatoid arthritis, has raised the issue about recovery for injuries suffered during clinical trials [see Death in Gene Therapy Treatment is Still Unexplained]. This is a very difficult situation since there is death of a young mother and a shattered family.
Lawsuits against researchers generally fall into one (or more) of the following 3 categories: breach of the standard of care; lack of informed consent; and/or conflicts of interest.
Basing your legal argument on informed consent forms or conflicts of interest is weak at best. Clinical investigators, pharmaceutical companies and IRBs are hip to litigation exposure so they carefully craft informed consent forms and disclose conflicts of interest to the study participant. The key is to argue that there was a breach of the standard of care.
Key to a breach of standard of care argument is whether or not the pharmaceutical company and/or the principle investigator owes a duty to the study participant. Traditionally there was no duty of care between the investigator and the study subjects. Where there is no duty of care there is no basis for recovery.
Clinical trial subjects must sign extensive informed consent forms, which will most likely include the injury in question. Various devices, including informed consent forms, used in the clinical trial process can arguably create a duty of care between the investigators and the study subjects. If you can prove that a duty exists and prove that the investigator and/or pharmaceutical company violated that duty and that violation was more likely than not the cause of the injuries then you maybe able to make a claim for damages.
The next question is how does one get around making a claim for an injury when the clinical trial subject signs a mountain of paper releasing the investigator from liability a/k/a the informed consent form. This is a very tricky issue but, in simple terms, an injured party must show that the injury resulted from a violation of the study protocol (the “rules” that govern the study) by the pharmaceutical company and/or principle investigator through gross negligence or explicit intent.
Suggested reading:
Myron Higgins, et al. v Kennedy Krieger Institute.
Popularity: 24% [?]
March of the Clones
September 17, 2007
For those of you who don’t know, when a drug is approved by the Federal Food and Drug Administration (FDA) it receives an indication which specifies its use. In order to maximize the profitability of their drugs, pharmaceutical companies initiate new clinical trials or sponsor research to search for additional indications and, if the data are favorable, they will file with the FDA for a new indication.
What is at issue here is not the new clinical trials or the new indications, but promotion of a new indication of a drug without proper approval by the FDA (off label promotion). This is a common tactic used by pharmaceutical companies. Companies employ teams of very attractive females and males (clones) to encourage physicians to write more scripts for the drug they are selling. Doctors that are targeted according to their practice area and could be visited by these clones several times a day. The clones are armed with a multitude of selling devices, such as money for lunch and, if available, copies of studies showing new uses for their drug. The clone then mentions the suggested new use with the hopes that the doctor will prescribe more of the drug. This is highly improper and endangers public health. Just to be fair, however, not all pharmaceutical companies engage in this activity.
The costs are high when companies get caught engaging in this activity. For example, Neurontin was originally indicated for diabetic neuropathy. Teams of medical liaisons, i.e. clones with advanced degrees, traveled to doctor’s offices to show them studies opening up new uses for Neurontin (sometimes these liaisons promoted new uses without studies). Their tactic worked as doctors began to prescribe Neurontin for all sorts of off label uses, including depression, bipolar disorder, and epilepsy. The joy was short lived, however, as Neurontin’s manufacturer Warner-Lambert was hit with extensive criminal and civil charges and eventually agreed to pay $250 million criminal fine, $83.6 million to the Federal government, and $38 million to consumers [see Drug Maker to Pay $430 Million in Fines, Civil Damages]. This example shows you that the risks are high but so is the return. A company can open itself up to 100s of new customers by promoting off label use.
So here we go again, Cephalon is the manufacturer of two extremely potent pain medications that are both indicated for acute cancer pain, the Fentora lozenge and Actiq lollipop. Cephalon is currently under congressional investigation of its marketing practices of its Fentora and Actiq product [see House Lawmaker Seeks Data From Makers of Stents and Drugs]. There have been reported four deaths recently attributed to the Fentora lozenge [see Cephalon's Fentora linked to four deaths; labeling revisions under discussion, spokesperson says] and Actiq has been noted to be prescribed for off label uses.
When is this going to stop? Never. As long as there is huge profit margin and an overworked and understaffed governmental agency, pharmaceutical companies will take advantage of the situation and the clones will continue to march to the cries of the consumer.
Popularity: 54% [?]
