Minding The Pharm

Michael E. Seelie is a Board Certified Civil Trial Attorney practicing in Jacksonville Florida.

In the first bisphosphonate case to go to verdict, a Montana state court jury on Oct. 21 awarded a plaintiff $3.2 million after finding that Novartis Pharmaceuticals Corp. was negligent in failing to warn her doctors of the risks of its Zometa bone-loss prevention drug and causing her osteonecrosis of the jaw (ONJ) (Peggy L. Stevens v. Novartis Pharmaceuticals Corporation, No. DV-08-100, Mont. Dist., 4th Dist., Missoula Co.).

The U.S. Food and Drug Administration is expanding its nationwide alert to consumers about tainted weight loss pills that contain undeclared, active pharmaceutical ingredients.

“These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages,” said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA.

“Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public.”

A recent article from the Associated Press is reporting that more people are putting their faith in alternative medicine. The occasion for such reportage is the FDA’s release of its first guidelines for good manufacturing practices in the supplemental industry, an aspect of modern health culture that is unregulated in this country. Concerned interest groups say the rules are flimsy. However, this is the first step to give the FDA more presence in this growing field.
The article is mainly skeptical about the possible health benefits of alternative medicines. The rise in popularity is attributed to the public’s growing distrust of the medical industry. Interestingly, the AP reporter focuses on prescription drugs.
“Mainstream medicine and prescription drugs have problems, too. Popular drugs such as the painkillers Vioxx and Bextra were pulled from the market after serious side effects emerged,once they were widely used by consumers. But at least there are regulatory systems, guideline-setting groups and watchdog agencies helping to keep traditional medicine in line.”
Unfortunately, the safeguards cited above are not as reliable as we would like to believe. In her book, The Truth About the Drug Companies, Dr. Marcia Angell draws upon her extensive experience as editor of the New England Journal of Medicine to reveal some of the ways drug companies evade regulations and prevent objective research for the sake of their profit margins.
Perhaps the most disturbing of these methods is the use of CROs (contract research organizations) to conduct the clinical trials that are the brick and mortar of any drug’s claim to legitimacy. Clinical trials are how drugs get FDA approval and doctor support before you are prescribed anything. CROs are for-profit companies that cater to the drug company’s need for data and reports, the paper life of their industry. Because of this financial relationship, the CROs are less committed to presenting evidence and objective analysis. More likely, the purpose is to make the drugs look better than they are by skewing data. This is as simple as altering dosage, suppressing unwanted data, or overemphasizing the positive results.
The result of such activities is clear. In the AP article, Dr. Josephine Briggs, who directs the federal agency that studies supplements and unconventional therapies, said “If we had highly effective, satisfactory conventional treatment we probably wouldn’t have as much need for these other strategies and as much public interest in them.”

Michael E. Seelie is a board certified civil trial attorney practicing personal injury and products cases in Jacksonville, Florida.

With so many instructions and warnings on a bottle of prescription pills, one would think that the last person to disregard the intended use of a drug would be the doctor prescribing it. “Off-label” prescriptions are exactly that, and a number of legal cases are coming to trial because of the growing trend in pharmaceutical marketing of encouraging this practice.

Off-label prescriptions exist in a gray area of medicine. Birth control is regularly prescribed for minimizing menstrual cramps and clearing up acne. Rogaine’s use for baldness was prescribed off-label for years before the FDA approved it. So that while the practice is not in keeping with FDA regulations, some advocates claim that the practice is not necessarily illegal either.

James Beck, a defense attorney and co-author of the Drug and Device Law blog, claims that most off-label use is beneficial and it is only the few disasters that get noticed. In fact, in 2008 the FDA rules for the promotion of off-label drug use became lax, but the Obama administration has yet to review these new regulations.

However the cases that have come to trial have not been about doctors finding creative ways to treat patients; they are about corporate marketing systems designed to create new outlets for sales.

For example, in March, Johnson & Johnson was ordered to pay the state of West Virginia $3.95 million for misleading doctors about the risks and benefits of Risperdal, an antipsychotic. The pharmaceutical giant is facing an even larger case in Texas. (http://industry.bnet.com/pharma/10001223/jj-fined-5000-per-sales-rep-visit-for-risperdal-mismarketing/).

Currently, in this country, if a person or groups of people, are injured as a result of a drug (pharmaceutical) our tort system allows the injured party to sue the company for damages. As with any lawsuit for personal injury, there are several requirements that prevent the act of “suing” the company from becoming “frivolous”. The injury has to have caused damages and has to be as a result of the drug. (causation) Furthermore, it will have to be proved that the company knew of the problem and did nothing about it.

Until the lawsuit is filed, the pharmacuetical companies do not have to share any of what they knew or did not know about the problem with anyone. Problems with drugs in developement are supposed to be reported to the FDA but it has been shown time and again that is not always the case.

Now, there is a case in the Supreme Court, that has the potential to make pharmacuetical companies immune to lawsuits if a particular drug has already recieved FDA approval. The purpose of this blog is to discuss some of the problems in the current system and explain why this is a bad idea for comsumers. Read more at

In today’s prescription-drug marketplace competition is stiff for essentially the same population of patients. Only a fraction of the drugs seeking new drug approval offer a clear advantage of what is already on the market. Many of the other drugs are considered “me too” drugs because they are similar to those already on the market.

Examples of these drugs occur in many therapeutic classes- antidepressants, nonsteroidal antiimflammatory drugs, antiulcers drugs, osteoporosis drugs, etc.

Victory in these therapeutic- class wars can mean millions of dollars for a drug company. But for patients and providers it can mean misleading promotions, conflict of interests and increased cost for healthcare and sometime inappropriate prescribing. Read more about this in the New England Journal of Medicine.