Charlottesville Personal Injury Lawyer - Drug

FDA Slow In Banning Fraudulent Drug Researchers

Greg Webb — Sun, 01 Nov 2009 09:52:38 GMT

In a report scheduled for release on Thursday, Congressional investigators say the Food and Drug Administration (FDA) pays little attention to its duty to ban investigators that are convicted of fraud; it is so disorganized that it takes an average of four years to complete its actions. For example, Delfina Hernandez helped to implement one of the most audacious drug research frauds in American history. Hernandez was a study coordinator at the Southern California Research Institute, a drug testing operation in Whittier, California that federal agents raided in 1997. The institute conducted more than 170 drug studies for almost every major drug manufacturer in the world and regularly falsified patient records and data while doing so. Hernandez plead guilty to fraud, thus requiring the FDA to ban her from participating in further drug research. The agency had five years after her conviction to act, however, because regulators sent her a legal notice years late and to the wrong address, she can legally continue to conduct research. When the agency finally learned of its mistake, it was too late for the ban to take affect.

In a review of eighteen proceedings, investigators from the Government Accountability Office ("GAO") found it took anywhere between one to eleven years to complete its ban on fraudulent researchers. This means the researchers were able to conduct experiments for years following their supposed ban. The FDA has claimed it has corrected this problem with increased staffing and centralized coordination. House Representative Joe Barton, the senior Republican on the House Energy and Commerce Committee, criticized the FDA’s slowness in banning fraudulent investigators and has promised to introduce legislation to give the agency more power to ban researchers convicted of fraud from later participating in any kind of human research.

Congress needs to act quickly and decisively to correct this "loophole". This type of governmental oversight is unacceptable.

Originally posted at InjuryBoard by Greg Webb

Supplements - More Dangerous Than They Appear (Or Advertised)?

Greg Webb — Fri, 25 Sep 2009 01:00:00 GMT

In its September 7^th article “What’s Really in Supplements?” The Wall Street Journal (WSJ)discusses the harmful side effects of a growing trend in the American dietary and strength conditioning communities: the taking of over-the-counter supplements.

Many supplements purport to aid in the building of muscle mass or in weight loss, claiming to do what prescription or illegal drugs do via an herbal means. However, the truth is that a great deal of these supplements contain at least trace amounts of the very drugs they claim to emulate.

Recent reports from the Food and Drug Administration (FDA) address the discovery of illegal performance-enhancing drugs in “allegedly natural supplements.” The WSJ article states that “[n]early two-thirds of American adults take dietary supplements, a broad category that includes vitamins, minerals and herbal products.” Supplement manufacturers are able to get their products quickly to market because they don’t require the extensive testing that new drugs do, and thus don’t require approval by the FDA. Furthermore, the WSJ says that “supplements that are made from products that were on the U.S. market before 1994 – as most commonplace ones are – can be sold without being reviewed by the FDA beforehand. Companies that include newer substances are supposed to inform the agency before they go on the market, but they don’t have to wait for approval.”

The recent attention stirred by the reports will be discussed during a hearing this month by a Senate Judiciary subcommittee. The focus of the hearing will be on dietary-supplement safety.

While officials at the Council for Responsible Nutrition are arguing that “no new laws are needed, citing new FDA manufacturing standards for supplements…as well as a requirement for supplement makers to tell the FDA when they get reports of serious side effects, which took effect at the end of 2007,” consumer advocates continue to call for closer monitoring.

A 2007 survey conducted by the British lab HFL Sport Science regarding supplements “found the undisclosed presence of steroids in at least trace amounts in 25% of the 52 samples analyzed,” and a 2008 article published in the journal Gastroenterology claimed that “9% of the 300 cases then recorded” could potentially be linked to supplement-taking. Since December 2008, “the FDA has issued warnings about more than 70 weight-loss supplements that included potentially dangerous ingredients.” The side effects of such ingredients could include seizure, heart attack and stroke. Liver and kidney failure have also been common in cases where a supplement taken regularly contained anabolic steroids. “Ed Wyszumiala, general manager of dietary supplement programs for NSF International, a nonprofit organization in Ann Arbor, MI that certifies supplements’ safety, says the drugs and steroids likely get into the products through a combination of deliberate spiking and inadvertent contamination.”

Vice President Andrew Shao of the Council for Responsible Nutrition “says safety problems are a ‘rare occurrence.’” He considers the HFL survey a “‘marketing tactic’” and says that consumers need to know what they’re taking as well. This is true. Consumers who take dietary supplements should be aware their ingredients and what those ingredients do. Research has been conducted on numerous herbs, most of which can be found online. In addition, Travis Tygart, chief executive of the U.S. Anti-Doping Agency, says that people who are interested in take supplements should speak with a physician. This would also help prevent dangerous interactions between prescription drugs and the supplements.

Preventative measures could include researching evidence, side effects and interactions at the National Library of Medicine (www.medlineplus.gov) under “Drugs and Supplements,” searching for specific supplements at www.fda.gov, as well as reading closely into what a supplement’s packaging discloses in subtext. “Certain suffixes in chemical names are common for steroids or tweaked versions of them. Among them are –one, -ene, -iol and –bol, though these can also appear in the names of legitimate ingredients. Some products also use versions of steroid names in their brands, like ‘tren’ to connote trenbolone.”

People using supplements should be aware of warning symptoms that could be indicative of an escalating problem. These include nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, yellow corneas and skin, and discolored urine, as cited by the FDA as warning signs of potential steroid use.

The Wall Street Journal article contains a complete list of resources for researching supplements.

Originally posted at InjuryBoard by Greg Webb

Bayer Warned By FDA Regarding Birth Control Products Quality

Greg Webb — Thu, 24 Sep 2009 22:00:35 GMT

Food and Drug Administration (FDA) regulators have written a letter warning drugmaker Bayer about quality control issues in the company’s plant in Berghamen, Germany. This plant is responsible for making drospirenone, the key ingredient for popular birth control drugs like Yaz and Yasmin; these products were Bayer’s top selling pharmaceuticals last year, with global sales of $1.8 billion. Instead of reporting individual tests results, FDA officials said the company measured the quality of its drug ingredients based on an average of several samples; Bayer shipped eight drug batches to the U.S. to be tested for quality using the sample average method, however the FDA does not allow this.

In April, Bayer responded to the FDA’s allegations by stating the quality in all drug batches shipped to the U.S. between 2007 and 2009 were not affected. In response, the FDA wrote another letter disagreeing with Bayer’s “rationale and conclusion.” While the FDA has not advised patients to stop using the products, they have asked Bayer to supply an entire list of all shipments to the U.S. that may have used the averaging method and provide a plan that would prevent the problem from recurring. The agency also said it was considering delaying imports from the German factory until Bayer addresses the warning letter.

New FDA Commissioner Margaret Hamburg has announced many changes designed to speed the pace of warning letters. This includes a streamlined review process for sending letters and shorter deadlines for companies to respond.

Originally posted at InjuryBoard by Greg Webb

Antidepressant Use in US Doubled To Over 10% in Ten Years

Greg Webb — Thu, 27 Aug 2009 11:04:47 GMT

A recent study released by Columbia University has found that compared to data from 1996, the number of Americans taking antidepressants doubled to 10.1 percent of the U.S. population in 2005, increasing across both income and age groups. Another recent study also found that diagnoses of major depression in adults increased from 3.3 percent in 1991-1992 to 17.1 percent in 2001-2002. It is unclear, however, whether there are more people with depression or if doctors are prescribing antidepressants more readily. The study also found that the number of children aged 6-17 that take antidepressants jumped to 78 percent during this time period as well. By 2005, an estimated 26 million Americans ages six and older were taking the drugs, while their use of psychotherapy declined.

The data further showed a jump in the use of antidepressants across demographic groups, with the exception of African Americans; the rate of use of the medications among the black population in 2005 was 4.5 percent less than in whites. The new study also found a greater emphasis placed on medicine solving the problem of depression, not therapy, which resulted in a decline in non-drug therapy. In 1996, about 36 percent of people being prescribed antidepressants also underwent therapy, while in 2005 the number decreased to 20 percent. Mark Olfson, the lead author of the study, says the decline in therapy could be caused by the fact that people have to pay more out of pocked for that treatment. He goes further to say that therapy and medication together is the most effective way to treat depression.

Each person treated for depression in 2005 also filled their prescription more than they did in 1996, 5.6 times in 1996 and 6.9 times in 2005. This surge in antidepressant sales propelled this class of treatment to become the top selling U.S. medication in 2005, surpassing blood-pressure medications. Olfson stated these findings emphasize the need for doctors who are not psychiatrists and who prescribe these medications to be trained to diagnose and manage depression so patients receive the most effective treatment. Rising use of the drugs may be a result of more Americans acknowledging they are depressed, the introduction of new antidepressants, an increase in direct-to-consumer advertising, and a lessening stigma for seeking mental health care.

The data in the study was collected from the 1996 and 2005 Medical Expenditure Panel Surveys, which are sponsored by the Agency for Healthcare Research and Quality.

Originally posted at InjuryBoard by Greg Webb

Vermont Law Makes Payments to Doctors Public

Greg Webb — Sat, 30 May 2009 22:06:08 GMT

In an attempt to crack down on the medical industry’s payment to physicians, Vermont legislators have passed a law that requires drug and device manufacturers to publicly release the amount of all money given to doctors and other healthcare providers, naming names and listing the actual dollar amounts. This law is scheduled to go into effect July 1, and would also ban almost all industry gifts, even meals, to nurses, doctors, medical staff, pharmacists, health care facilities and healthcare administrators. It is believed to be the strictest state effort to regulate the marketing of medical products to physicians, though Minnesota and Massachusetts have less stringent laws in place. Ideally, the measure would allow residents of Vermont to annually learn how much each doctor was paid by makers of the brand-name drugs for which they wrote patients’ prescriptions, or how much money surgeons received from the manufacturers of certain devices, like stents, that they implant.

National legislators and medical groups are monitoring the different state laws, like the one in Vermont, in their quest to discover a link between health care costs and industry marketing. In Congress, Republican Senator Grassley and Democratic Senator Kohl have sponsored a bill that would require disclosure of the pharmaceutical industry’s payment to doctors. Vermont’s law, however, goes even further by showing the issue is inappropriate gift giving. It requires all payments to any health care provider be disclosed, as well as requiring device manufacturers to disclose information as well; the law is also the first to ban all free meals, which was a favored gift used in marketing to doctors, and closed a loophole that allowed companies to not disclose information by calling them “trade secrets”. The required disclosures, however, do not include payments for clinical research on products that are still under examination by the Food and Drug Administration (FDA).

Vermont legislators passed the measure after information was released by the attorney general stating manufacturers of medical products spent about $2.9 million in fiscal year 2008 on marketing to healthcare personnel in their state. About half of Vermont’s physicians were also given compensation from pharmaceutical companies; the manufacturers focused mainly on those doctors they considered “elite”, with only four percent of these doctors receiving more than sixty percent of the payments. The reports also raised the point that if drug manufacturers were willing to spend that much money in the small state of Vermont, what would the results be in the big states of New York and California?

This law is, at least at first glance, a positive step in curbing the corporate greed of the medical device and pharmaceutical industries. It will be interesting to see how this law plays out over the coming years as far as its success in actually accomplishing its goal and, perhaps, curbing health care costs. Hopefully, there are no bad, unintended consequences.

Originally posted at InjuryBoard by Greg Webb

AP Report Shows Pharmaceuticals Tainting Drinking Water

Greg Webb — Mon, 27 Apr 2009 08:00:00 GMT

According to an investigation by the Associated Press, U.S. manufacturers, including drugmakers, have legally released at least 271 million pounds of pharmaceuticals into the waterways that often supply drinking water. Hundreds of pharmaceutical ingredients are used in drug manufacturing. For example, copper, which is also used in piping, is also used in contraceptives; nitroglycerine, which is used in explosives, is a heart drug.

Federal and industry officials say they do not know the extent to which manufacturers release the pharmaceuticals because no one tracks them. An analysis of about twenty years of federal data, however, found the government does unintentionally keep data on a few. Twenty-two of the compounds showed up on lists compiled by the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA). The EPA classifies them as industrial chemicals released into water under federal pollution laws, while the FDA monitors them as active pharmaceutical ingredients.

It is unknown how much of that 271 million pounds comes from drug manufacturers versus other manufacturers. Researchers claim the lack of testing has created a “don’t ask, don’t tell” policy regarding whether drugmakers are contributing to the pollution. Drugmakers have insisted that their manufacturing does not significantly contribute to what is being found in the water. Federal drug and water regulators concur, although there have been trace amounts of a wide variety of pharmaceuticals in drinking water, such as antibiotics, mood stabilizers and sex hormones.

Originally posted at InjuryBoard by Greg Webb

FDA Rules Regarding Internet Drug Ads Create Confusion

Greg Webb — Sun, 26 Apr 2009 08:00:00 GMT

Late last month, the Food and Drug Administration (FDA) sent strong warning letters to fourteen major pharmaceutical companies that the companies’ search advertisements, or the short text ads that run beside Google results, have to include risk information about each drug or else be removed. The letter cited examples of Celebrex, Propecia and Yaz, which did not include the precautions that the agency required. The drug manufacturer Merck, for example, was reprimanded by the FDA for making its drug Singulair appear safer than has been demonstrated. Many feel this is sign of increased vigilance in the new FDA administration.

Until the letters were issued, drug companies assumed there was a one-click rule, which required them to publish risk information within one click of their ads, or on the page that the ad linked to. The companies argued that the FDA is ignoring the realities of internet marketing; there is no way they can include all of the required information in the ads because Google only allows ninety-five characters for search ads. While companies are changing their ads to comply with the warning, executives say the solution is worse than the problem; advertisements are now even more misleading. Representatives for the FDA, however, say if there is not adequate risk information, or you overstate the benefit of a drug, that is false advertising; risk information is required on every advertisement no matter the medium.

Drug companies changed almost all of their ads after receiving the letters because they do not want to be on the wrong side of the FDA, however, the sense in the industry was that the letters were just telling what they should and shouldn’t do as opposed to giving strict mandates. Online advertisements are now using generic-sounding brand names to redirect to a brand’s website. Propecia, for example, now redirects links through a website called “hair-loss-medication.com” instead of propecia.com.

These solutions have problems, however, in that consumers may think these sites are neutral when they are really redirected to a sales site. In fact, Google will only allow pharmaceutical companies to redirect this way. Consumers will also rarely see the official websites in the sponsored search results and will instead see links to Canadian pharmacies and other unregulated herbal offerings.

Originally posted at InjuryBoard by Greg Webb

Researcher Alleged to Have Ensured Positive Results To Drug Makers

Greg Webb — Fri, 03 Apr 2009 13:06:54 GMT

According to court documents, an influential child psychiatrist at Harvard University, told drug maker Johnson & Johnson that planned studies of its medications in children would produce results that would benefit the company. The psychiatrist outlined his plans to test the company’s drugs in presentations made to Johnson & Johnson’s executives. One slide referred to a plan to conduct a trial of risperidone, an antipsychotic drug, on preschool children. He allegedly claimed he would support the safety of this drug on the age group.

The doctor was the director of the Johnson & Johnson Center for Pediatric Psychopathology Research at Massachusetts General Hospital. He reportedly is one of the world’s most prominent advocates for diagnosing bipolar disorder in young children and using antipsychotic medication to treat this disease. He was the lead author of a trial published last year, which concluded treating a patient with risperidone improved the symptoms of attention deficit and hyperactivity disorder (ADHD) in bipolar children. A research scholar at a bioethics research institute raised questions, however, regarding how well-designed the doctor's trials were because of the alleged promise of a positive result to his funders.

Because of his association with Harvard University, the psychiatrist also faces claims of a conflict of interest in medicine, along with the claims he should not prescribe antipsychotic medication to children. The doctor has become a key witness in numerous lawsuits claiming the makers of antipsychotic drugs defrauded state Medicaid programs when they improperly marketed their products. As demonstrated through e-mails and internal documents presented in court, the doctor's work allegedly helped to increase the sales of these medications for children.

Much of the psychiatrist's work, however, was supported by the drug makers for whom he privately consults. From 2000 to 2007, he reportedly earned $1.6 million in consulting fees from these drug makers and allegedly failed to report all but $200,000 of it to Harvard University officials. Harvard and the National Institute of Health are now investigating whether this violates federal and university research rules. A New Jersey Superior Court judge, who is overseeing the multistate litigation, ruled that the doctor should be deposed. This has reportedly provoked him to suspend working with the drug industry during the investigation.

www.nytimes.com/2009/03/20/us/20psych.html

If the above allegations are true as reported, this is astounding. The drug companies have gotten to the researchers, governmental officials, governmental bureaucrats, governmental agencies, and on and on. Profits at all costs, and by all means, must end.

Originally posted at InjuryBoard by Greg Webb

Tattoos, Nicotine Patches And Other Medical Devices May Pose Problem During M.R.I.s

Greg Webb — Tue, 31 Mar 2009 17:44:35 GMT

Federal health officials warn that patients who wear nicotine or other drug patches during M.R.I. scans may get burned due to the machine’s huge magnet that can heat tiny metal elements found in the patches. Not all patches contain these aluminum elements. The Food and Drug Administration (FDA) has received at least five reports of patients wearing patches who experienced a skin burn similar to a sunburn during an M.R.I. screening; federal officials are usually only alerted to a fraction of the injuries associated with a particular drug or device so the number may be much more.

About sixty different types of drug patches are sold in the United States, and about twenty contain the small metal fragments. Some of the patches do not warn patients about these metal fragments, and since few people review the box after donning the patch, the FDA will soon require that all manufacturers put warnings, such as "Remove Before M.R.I." on the patch itself. Patients should consult their physician regarding whether or not to replace or reuse the patches after removing them for scans.

This patch alert is the latest in an assortment of safety warnings involving increasingly powerful M.R.I. devices, due to the unpredictable effects of strong magnets used in the devices that are continuing to be discovered. Radiologists are now warning patients that they can experience discomfort or injury if they have tattoos, implanted medical devices or shrapnel. Tattoos also contain metallic elements in some cases, which can lead to warming in the skin that can grow uncomfortable. Some M.R.I. screening rooms place metal detectors in front of the rooms to prevent the problem of patients forgetting to remove metal objects before entering.

Originally posted at InjuryBoard by Greg Webb

Recent Supreme Court Ruling Bring Back Issue of Medical Devices

Greg Webb — Sat, 21 Mar 2009 21:31:52 GMT

The U.S. Supreme Court recently ruled that consumers can sue drug makers for defective warnings, though earlier ruled consumers cannot sue medical device manufacturers if the device was FDA approved. This seemingly contradictory ruling claims federal law does not protect drug companies from product liability suits in state courts, though it earlier decided federal law prevents lawsuits against the manufacturers of such medical devices as heart stints and artificial joints. In the drug maker case, the defendant, drug manufacturer Wyeth, argued federal oversight of drug labels by the Food and Drug Administration (FDA) precluded state courts from hearing drug injury lawsuits; the Court ruled, however, that consumers may sue the manufacturer in state court for a defective warning. The Court distinguishes the two cases by pointing out that there are different legal issues involved.

Experts believe that after this decision, there may be an influx in the amount of lawsuits drug makers will face because the FDA approved label will not provide a cover for the industry. Drug maker supporters fear the verdict could make companies more reluctant to produce beneficial drugs if the drugs pose a high risk. The decision could also offer support to some members of Congress who are planning to introduce a bill that would supersede the Court’s medical device ruling, thus allowing injured people or their survivors to sue faulty device makers. Many hope the outcome will lead to more updated labels of possible side effects, though it would require FDA approval every time.

The Wyeth ruling was a victory for consumers – for normal citizens. It was a blow to big business, especially the pharmaceutical industry. If it could, the pharmaceutical industry would have the federal government give it blanket immunity from any law suits, no matter how egregious its conduct. Because the FDA is unable to adequately police the pharmaceutical industry (for a variety of reasons, including funding), one of the most effective checks on that industry is the product liability lawsuit. Wyeth gave this writer hope that that our Court is not turning into the “Corporation Court”, rubber-stamping whatever the industry wants.

Originally posted at InjuryBoard by Greg Webb