As the investigation by the U.S. House of Representatives’ Energy and Commerce Committee into the causes of a recent outbreak of fungal meningitis continues, it seems to be revealing more and more disturbing information about what happened and why.
The investigation began after a Tennessee man was diagnosed with fungal meningitis. Since this type of meningitis is very rare, his doctor investigated further in addition to reporting it to the Tennessee Department of Health. Since the patient had taken a back injection shortly before developing meningitis symptoms, investigators looked at the plant where the injection was manufactured, the New England Compounding Center. They discovered fungus in other vials of medication.
The first question investigators need to ask is how the fungus got into the medication in the first place. It is likely that the NECC didn’t follow standard procedures to ensure a sterile environment. Investigators are looking at NECC’s manufacturing procedures as well as state regulators’ behavior. If state regulators regularly toured the manufacturing facility to ensure it was up to code, how did the contamination occur? Investigators also may want to learn more about how long the fungus takes to develop and how long NECC has been violating procedures if it turns out NECC has done so.
Investigators have also discovered that the FDA had concerns about the safety of NECC’s manufacturing process as far back as 2006. Thus, they want to know why the NECC was able to stay in business for another six years. The investigation is currently looking at state regulators to see whether they complied with FDA directives and state laws.
The most important question the investigation can ask is how to prevent future outbreaks of disease from contaminated medication. ALthough the meningitis outbreak is the worst example of contamination-driven disease in the United States, it’s far from the only one. Some consumer advocates believe that leaving regulation of compounding pharmacies to states rather than to the FDA is a bad idea. The FDA does not oversee these kinds of pharmacies, which increases the likelihood of non-standard and potentially hazardous practices.
The investigation should also look into what the FDA did to follow up on its concerns about NECC. If the FDA can’t take on oversight of all compounding pharmacies, perhaps it can oversee pharmacies that it has grave concerns about.
Over 14,000 people have been exposed to fungal meningitis as a result of the contamination. More than 10 percent of those people have become sick, and of the ones who have gotten meningitis, about 10 percent have died. It’s time to figure out exactly what went wrong and prevent it from happening again.
The federal government’s investigation into the recently outbreak of fungal meningitis, which occurred after patients were treated for back pain with contaminated steroids, has expanded to the state regulators who were supposed to be monitoring compounding pharmacies in Massachusetts.
The outbreak may be linked to steroid injections manufactured by the New England Compounding Center in Massachusetts. After a Tennessee man contracted fungal meningitis, federal investigators visited the NECC and found fungus in several vials of steroids. NECC voluntarily recalled the steroids; however, over 13,000 people had already received injections. Since the recall, 184 people have been diagnosed with fungal meningitis and 19 of those people died.
Consumer health advocates became critical of federal regulation of compounding pharmacies after this event, saying that the lack of regulation made it more likely that catastrophic events like this could occur. Compounding pharmacies are not overseen by the federal government; thus, there is greater chance that they deviate from standard procedures while making drugs. Advocates were concerned because compounding pharmacies make a wide variety of drugs to treat conditions from cancer to common colds.
Despite the lack of federal regulations, however, compounding pharmacies aren’t completely unregulated. State regulation agencies are supposed to oversee them. Thus, the U.S. House of Representatives has asked the Massachusetts Board of Pharmacies to share any information it had on New England Compounding Center prior to the outbreak with Congressional representatives. This testimony will allow federal lawmakers to determine whether state regulators did their job. It is unclear what will happen if it is determined the state regulators failed to regulate New England Compounding Center appropriately.
In the meantime, NECC has surrendered its license to manufacture pharmaceuticals in Massachusetts and is downsizing its workforce. It has also lost the right to license drugs in Michigan, where a large number of patients have been affected by the outbreak.
The investigation has already revealed that the FDA was concerned about the safety of steroids manufactured by NECC in 2006; state regulators are being called in to help determine why the company was still allowed to manufacture these drugs for six years after the initial concern.
NECC is already facing one lawsuit for allegedly causing a patient to get fungal meningitis; other lawsuits may follow. Senator Richard Blumenthal of Connecticut is calling for a criminal investigation of the company as well.
After becoming the best-selling diabetes drug worldwide in 2007, Actos has been banned in France and Germany. Since its release onto the market in 1999, studies have linked Actos to a 40 percent higher rate of occurrence for bladder cancer in patients who take the drug for an extended period. Consequently, France and Germany have ordered doctors to stop prescribing the drug due to the increased risk of developing bladder cancer. However, the European Medicines Agency, which regulates drugs in the European Union, has decided to perform a safety review, stating the drug may be safe in some instances. The French Medicines Agency also conducted a study which indicated that diabetes patients who use Actos have a 22 percent higher risk of developing bladder cancer than those who take other diabetes drugs. Actos has also been linked to increased incidence of heart disease, liver failure, bone fractures, and blindness.
Although Actos has been banned in France and Germany, the U.S. has been slow to limit sale of the drug. The FDA issued a drug-safety announcement stating that it will continually evaluate the findings of a study conducted by Takeda Pharmaceuticals, the makers of Actos, along with a French study that monitored 1.5 million diabetes patients. The French study found a “significantly significant increase” in the risk of developing bladder cancer in patients who were treated with Actos instead of other diabetes drugs. According to the FDA, it must first reach a general conclusion that there is a “reasonable probability” that the drug will cause death or serious negative consequences to one’s health. The FDA released a statement indicating that patients should consider the benefits of using Actos to control their blood sugar in light of the unknown risk of developing cancer.
While the FDA actively reviews the data from studies, it has issued advisories for those who might administer or take the drug. The drug’s label has also been updated to reflect that using Actos for a length of time longer than a year may be associated with a higher probability of developing bladder cancer. However, the FDA scaled back the advisory in May 2012 and now only requires that the warning be issued in a separate Medication Guide. Nevertheless, the FDA recommends that patients with active bladder cancer avoid Actos and that those with a history of bladder cancer carefully consider the risk of recurrence.
Scientists working for the U.S. Food and Drug Administration claim the agency spied on them illegally. In a court ruling, U.S. District Judge James Boasberg has ordered the FDA to immediately turn over 4,000 pages of material that the scientists requested. This ruling, in essence, speeds up the discovery phase of the trial. Additionally, remaining documents must be produced by September 10. All of these documents are in addition to ones that have already been released to the public.
The case started three years ago when it was discovered by the FDA that some researchers within the agency had contacted Barack Obama, President-elect at the time, with concerns about the process for approving medical devices. These employees criticized the procedures for approval, which they considered to be too lax.
Among the complaints, according the the lead attorney for the whistleblowers, Stephen Kohn, are 20 medical devices that could be exposing patients to dangers. For example, extremely high doses of radiation exuding from CT scanners and ultrasound machines may be exposing individuals to radiation levels that are 800 times higher than a chest X-ray, according to the lawsuit. Breast cancer detection devices were still approved by the FDA, even though the machines are not effective nor safe, per the researchers.
A serious concern arose from the employees when it was discovered that monitoring of their correspondence had begun, as well as monitoring of the interactions with each other on the job. Screenshots of individual computer screens were taken by the FDA. Gmail accounts were also under surveillance. Personal and private information that was stored on defendants’ computers was secretly obtained through these methods, it was learned. In addition, views of documents clearly marked for Congress were illegally obtained by the FDA through such spying, it is alleged.
In an inadvertent move, according to the contractor handling such government documents, much of the documented information was released on a public website earlier this month. It is estimated that there are possibly 80,000 pages of documentation regarding the surveillance activities. The researchers claim that their civil rights, such as unreasonable search and seizure, freedom of speech, and the right to petition Congress, have been violated. Kohn pointed out that monitoring done to every employee on a similar basis is not cause for a lawsuit. When monitoring is selectively done to individuals who are blowing the whistle, however, it is unacceptable.
Last month, Honorable Judge Carol Higbee of the New Jersey Superior Court ruled that three high level executives at Johnson & Johnson will have to testify in the controversial transvaginal mesh lawsuits. Higbee is in charge of more than a thousand transvaginal cases, which have been merged for litigation.
The three top executives of Johnson & Johnson are Alex Gorsky who is the Chief Executive Officer, Sheri McCoy who is the for Vice Chairman of the company and Gary Pruden who is the leader of the company's Ethicon franchise. Judge Higbee ordered all three executives to be prepared to give videotaped depositions.
In their depositions, they must explain what part they took in the production of the harmful mesh products that have caused injury to many people. The former Chief Executive Officer of Johnson & Johnson, Bill Weldon, may also be made to give a deposition if it is proven that he had prior knowledge that the mesh implants were a risk to patients.
Adam M. Slater, who is one of the lawyers for the plaintiffs, released a statement saying he is eager to question the executives about their knowledge of the defective mesh products. In addition, Slater said he hopes the truth will be revealed in the depositions.
In another ruling, Judge Higbee has said that the computers of the executives may be searched for evidence related to the case. Also, she said the computer searches must be conducted before the depositions are taken. In addition, Judge Higbee ordered that the plaintiffs will be informed of the results.
In defense of their clients, the defendant's lawyers argued to Judge Higbee that their clients have limited knowledge about the transvaginal mesh products because of their high level positions in the company. Judge Higbee did not agree with this assessment.
Johnson & Johnson agreed to remove the transvaginal products from shelves back in June after the FDA said they wanted to examine the products for their safety. Johnson & Johnson still claims their products are safe and effective and said they only removed the products due to public pressure.
The FDA has issued numerous alerts about the safety of transvaginal mesh products and has warned consumers about complications such as the corrosion of the mesh in the pelvic area. Surgeries to correct this problem have not always been successful. Many women suffer from various harmful side effects that include chronic pain and sexual dysfunction that could last for the remainder of their lives.
A treatment for pelvic organ prolapse and stress urinary incontinence, the transvaginal mesh has been linked to many serious complications. This device is a piece of mesh, surgically implanted through the vagina. This hammock-like device supports organs such as the bladder, rectum, and uterus to keep them from dropping when a woman's pelvic muscles are too weakened to support them. With hundreds of state and federal lawsuits underway for the manufacturers of this device, a California jury has finally reached a verdict on the first of these suits.
The jury ruled in the favor of Christine Scott, who will endure a lifetime of chronic pain after attempts to remove two transvaginal mesh devices were unsuccessful. Scott sued C.R. Bard and a doctor, claiming the device is responsible for her injuries. Scott has undergone eight separate procedures, along with nine revision surgeries, all which proved unsuccessful at removing the devices. Scott was awarded $5 million in her suit. The damage to Scott's body has left her no longer able to have sexual intercourse. Due to this fact, her husband was awarded $500,000 in the suit as well.
The transvaginal mesh was tested on rats, rabbits and sheep before prior to being used on women. However, Bard continued to market its Avulta line of transvaginal mesh devices even after several legal complaints of complications emerged. It wasn't until July that Bard put a stop to the use of these devices in the United States, following a request from the FDA to run further testing. The FDA has stated that the side effects of this device are not rare and it is no longer believed to be safer than the surgical treatment option.
The jury ruled that C.R. Bard was 60 percent responsible for Scott's complications. Bard's attorneys have expressed intentions to appeal this ruling, stating, "Throughout the case, we clearly have empathized with Mrs. Scott's injuries. We just don't feel that they were the result of the Avaulta Plus product or the conduct of our company???"
With hundreds of other cases in the works, this landmark ruling has set the precedent for future proceedings. The ongoing lawsuits have been divided into five multidistrict litigations. C.R. Bard is the defendant in one of these litigations
Academic research as well as clinical scientific trials need to be reproducible to be credible. With many more errors in these areas today, the Scientific Exchange, which is based in California, has announced a new program that will fact-check experimental findings.
Called the Reproducibility Initiative, a board of 10 scientists will review scientific findings and validate the deserving ones. This will improve the trustworthiness of reports and clinical papers. The Science Exchange is putting together this initiative along with two scientific publishing websites for an online marketplace for scientists.
There is a general lack of incentives and opportunities for validation. The percentage of studies that cannot be reproduced is a staggering 70 per cent. This is a huge waste of time and money, because the results are more often than not inaccurate.
In order to create medications that are successful and to be viable for funding opportunities, it is essential to validate study results. This means a third-party who can reproduce the research and clinical trials is vital for overall medical research. It is generally considered that the incentives are easily available for publishing sensational results that may or may not be accurate.
An example of this is the case of Dr. Scott Reuben who, in 2010, falsified 21 research papers. Several of these papers publicized the benefits of Vioxx, a pain killer that has since been the cause of thousands of lawsuits. Reuben may have received thousands of dollars in grant money for research that was never done.
Another example is a Kansas doctor who, in 2011, joined with a researcher to conspire with Schering-Plough, a subsidiary of Merck, to falsify data on research programs. Takeda pharmaceuticals was also accused in 2011 of falsifying data about the type 2 diabetes drug Actos to make it appear safe. This year, Cetero Research, based in North Carolina, forged thousands of documents of clinical trials for several drug companies in order to get federal approval. They are now continuing their work under another name, the PRACS Institute.
C. Glenn Begley, who is a former head of cancer research, has tried to replicate 53 experiments that are important for the treatment of cancer. He could not duplicate the findings of 47 of the experiments. Begley believed in these cases the cause was poor experiment procedures and sloppy reporting rather than outright fraud as was the case with Vioxx. Fraud accounts for a small part of the overall failures.
For the experiments they are able to replicate, the Reproducibility Initiative aims to give a seal of approval to the original team.
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