The AP (1/13, Perrone) reports that the FDA “issued enforcement letters to Eli Lilly, Bayer, Amylin Pharmaceuticals, and Cephalon for making inaccurate or incomplete statements while promoting their drugs.” The agency’s “letter to Lilly cites a print advertisement for the antidepressant Cymbalta, which is approved to treat depression, generalized anxiety disorder, diabetic nerve pain, and the pain ailment fibromyalgia.” The FDA indicated that Lilly’s ad fails to “adequately display information about the drug’s side effects.” Dow Jones Newswire (1/13, Favole) reports that the FDA said Amylin and Lilly representatives overstated diabetes drug Byetta’s weight loss benefits, and that Bayer’s promotional material for the birth-control drug Mirena does not adequately warn women of the risk of losing their baby if they become pregnant while taking the drug.
Meanwhile, the FDA’s letter to Cephalon said the drugmaker did not include important risk information on a dosing card for its lymphoma treatment Treanda, Reuters (1/13, Heavey) reports. The FDA asked that the drugmakers halt use of the advertisements and promotional materials immediately.
In a column at Portfolio.com (1/4), Ed Silverman writes that critics say sales of atypical antipsychotics have been spurred in part by “an epidemic of off-label marketing. And so drugmakers encouraged doctors to prescribe these meds for children before the FDA sanctioned their use for youngsters.” Another side effect “is even more disturbing-unnecessary deaths among elderly patients, who shouldn’t receive these medicines if they suffer from dementia.” Robert Rosenheck, a Yale University professor of psychiatry and epidemiology and director of the Division of Mental Health Services and Outcomes Research, said, “The general public and the patients may not be better off. There’s evidence the drugs aren’t always effective, may be harmful, and can cost a good deal of money, but there’s nothing we can do about it, because we’re committed to the principal that doctors should be able to choose whatever treatments are best for their patients.”
The Food and Drug Administration said from 2006 to 2008 it received 35 reports of severe cartilage damage in patients who were given pain pumps after joint surgery. Nearly all the reports involved patients who had shoulder surgery; more than half needed additional surgery, including joint replacement. Now, federal regulators are demanding changes to labels on the devices.
The Companies making pain pumps have 30 days to propose language that includes a warning about the potential for cartilage destruction, according to an FDA spokeswoman.
“The significance of this injury to otherwise healthy young adults warrants notification to health-care professionals,” the FDA said in a notice to doctors and other health care professionals Nov. 13.
APP, Stryker and Hospira all make the pain pumps. The anesthetics in the FDA’s alert include bupivacaine, marketed as Sensorcaine or Marcaine, and lidocaine. These anesthetics, the FDA noted, have been used safely in single injections for many years without any reports of cartilage decay.
Reports about decaying cartilage after shoulder surgery, when the pumps were involved, began surfacing several years ago, followed by studies in medical journals on orthopedic surgery and sports medicine. If you have suffered severe cartiledge damage as a result of these pumps, contact a Jacksonville Personal InjuryAttorney.
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.).
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/).
One technique used by drug companies to promote “me too” drugs are “seeding” trials.
When a company-sponsored trial of an approved drug serves little or no scientific purpose, but are, in fact, thinly veiled attempts to entice doctors to prescribe a new drug being marketed by the company, they are often referred to as “seeding trials.”
Features that distinguish such trials from scientifically rigorous studies include:
· stated research goals not supported by the design
· Recruitment of investigators because they are frequent prescribers of competing products in the same therapeutic class and not because they are experts researchers in the field
· High payments given to “investigators” for their work (although the only work may be to write prescriptions for the drug),
· The study is sponsored by the company’s sales and marketing division rather than its research department,
· Minimal requirements for data, and the collection of data that are of little or no value to the company.
Typically, these trials involve introducing a new drug in a crowded therapeutic class. The idea is to undo the physicians’ old habits of prescribing a competing, more established product and start a trend toward prescribing the new “me too” drug.
Category: General
Posted by: Bseel
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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.