Lansing Personal Injury Lawyer - Drugs

Pharmaceutical Companies Use Rx Data Mining to Boost Sales Tactics, Patient Advocates Argue

David Mittleman — Thu, 03 Dec 2009 16:06:36 GMT

When your doctor prescribes you a medication you probably expect that the information stays between you, the doctor, and your insurance company. However, prescription data miners are changing that dynamic in scary ways: by spying on your prescription data they are able to provide pharmaceutical companies with information to entice doctors to prescribe their medications more frequently. In fact, pharmaceutical companies are able to learn how to “fine-tune” their messages so that when a sales-rep calls a doctor, they are able to give a good pitch. Furthermore, pharmaceutical companies can entice doctors to prescribe their medications with free samples of drugs. While the individual identities of patients is not disclosed in data mining, government officials are concerned about doctors’ decision-making becoming distorted because of the new sales tactics of pharmaceutical companies with access to prescription information.

The process of prescription data mining begins with medical data firms. Medical data firms have access to billions of prescription records, which they purchase from pharmacies and health insurers who have physician data from the American Medical Association, as well as other sources. They then are able to sell this information to pharmaceutical companies. According to critics, the end result is that drug companies are able to sell their newest and costliest medications, not necessarily the most effective medications.

Patient advocates and government officials are also concerned about the interference in the patient-doctor relationship, as well as increased spending on expensive drugs. However, data miners argue that they are actually helping contain the cost of prescription medications by improving quality and by quickly providing doctors with information on which drugs work best.

Originally posted at InjuryBoard by David Mittleman

FDA Trying to Reduce Preventable Medical Error from Prescription and Over the Counter Drug Use

David Mittleman — Sun, 29 Nov 2009 10:39:08 GMT

Over 3 billion prescriptions are written annually in the United States, and tens of millions of people rely on prescription and over-the-counter (OTC) drugs to sustain their health. With such high numbers of drugs being used, the risk of preventable medical error from improper drug combination or the misuse of medication has led the Food and Drug Administration (FDA) to start the Safe Use Initiative.

As my Virginia-based colleague Greg Webb noted, the initiative calls upon doctors, health care professionals, and even patients to help the FDA identify specific, preventable medication risks and develop interventions to such risks. The initiative has a goal to implement some interventions within the first 12 months of the Initiative's existence.

Among the target groups the Initiative seeks to protect is children. One study cited by the FDA found that over 9,000 children were exposed to prescription opioid drugs from 2003 to 2006. Just as startling was the fact that 60,000 emergency room visits occur annually as a result of unsupervised ingestion of medication by children under the age of 12.

Some of the changes consumers can expect will be better information of the prescription and OTC drugs they take, including the proper dosage to take along with calibrated spoons or cups that are easier to read and correspond with the product's packaging.

Originally posted at InjuryBoard by David Mittleman

Drug Makers Raise Prices Despite Promises of Cost Reform

David Mittleman — Wed, 18 Nov 2009 09:39:28 GMT

Drug makers pledged to help cut down healthcare costs by $8 billion a year, but now it doesn’t look like they are making good on that promise. Instead, in the last year alone, the pharmaceutical industry has raised their wholesale prescription drug prices by 9%. Instead of cutting down on costs, that raises the nation’s drug-related healthcare costs by $10 billion, and represents the highest annual rate of inflation on drug prices since 1992.

Originally, drug makers had touted their agreement with the White House and the Senate Finance Agreement chairman to trim $8 billion a year from the nation’s drug costs, or $80 billion over 10 years, by giving rebates to older Americans and the government. However, the recent increase in prices would essentially cancel out the savings for at least the first year of the plan, if not the entire 10 years.

Nevertheless, drug makers argue that there are valid business reasons for raising prices. Specifically, they argue that they are forced to raise their prices in order to invest in future research and development of new drugs, especially as patents expire on previous drugs. While drug makers claim their “reasons” for raising their prices, many Americans who do have drug insurance will be forced to pay out-of-pocket for the leftover cost of overpriced drugs that insurance won’t entirely cover.

Originally posted at InjuryBoard by David Mittleman

CDC Links Two Antibiotics Taken During Pregnancy to Subsequent Birth Defects

David Mittleman — Fri, 06 Nov 2009 10:00:00 GMT

Researchers at the Centers for Disease Control who studied the effect of antibiotics during pregnancy have discovered a link between birth defects and several types of antibiotics, specifically those to treat urinary tract infections, which are referred to as sulfa drugs and nitrofurantoins. However, the most common antibiotic given during pregnancy, penicillin, appears to be the safest.

The new study is the first large-scale research effort to study the effects of antibiotics on pregnancy. Furthermore, it was the first time that researchers were able to find an association between urinary tract treatments and birth defects. The study, which will be published in the November Archive of Pediatrics and Adolescent Medicine, looked at 13,000 mothers whose infants had birth defects as well as 5,000 women with healthy babies who lived in the same regions. The women were interviewed by phone for six weeks to two years after their pregnancies and any that reported having taken antibiotics during the month before conception through the first three months of pregnancy, were identified as exposed to antibiotics.

While the study is revealing and could help doctors decide which antibiotics to avoid giving to pregnant women, the researchers cited a weakness in the study: the women’s memories of which antibiotics they took could be faulty. Furthermore, the underlying condition, rather than the antibiotics, could have also contributed to birth defects. Nevertheless, the researchers concluded that sulfa drugs caused birth defects such as rare brain and heart problems and shortened limbs. Similarly, nitrofurantoins contributed to heart problems and cleft palate. Overall, the drugs seemed to double or triple the risk of these specific types of birth defects.

For further information and links, please visit Jane Akre’s blog on antibiotics and pregnancy at the National Injury Board News Desk.

Originally posted at InjuryBoard by David Mittleman

GAO Report Reveals that FDA is Failing on Forcing Drug Makers to Prove Drugs Work

David Mittleman — Wed, 28 Oct 2009 09:49:14 GMT

According to a Government Accountability Office report released on Monday, between 1992 and 2008, the Food and Drug Administration asked pharmaceutical drug makers to complete 144 studies associated with 90 applications waiting for approval. However, drug makers only completed 2/3 of the requested studies. Overall, the study indicates that serious problems still exist: federal drug regulators have repeatedly failed to force drug makers to comply with FDA requests to prove that their pharmaceutical drugs work. This is particularly problematic for patients, who remain uninformed about whether or not their medications are actually beneficial.

In fact, concerns over the FDA’s ability to prompt drug makers to complete requested studies reached such a crescendo, that Congress passed a law in 2007 giving the FDA greater power in enforcing such rules. Since that law passed, the FDA can fine drug makers if they fail to follow through with promised studies.

All of the 90 applications cited in the recent GAO report were submitted to the FDA under a program that expedites the approval process for life-threatening conditions like cancer or HIV/AIDS. Under the accelerated-approval program, the FDA often approves medications that may or may not be beneficial in treating these diseases. However, after a drug is approved through the expedited process, the drug maker is supposed to conduct confirmatory trials to prove that the drug is beneficial. Nevertheless, the process is still risky: some patients may benefit from a drug. On the other hand, the most vulnerable could also suffer needlessly from the side effects of a medication, while experiencing very little improvement in their condition. In response to the recent GAO report, the FDA’s principal deputy commissioner has promised that the agency is overhauling their tracking system and that the problem will be fixed.

Originally posted at InjuryBoard by David Mittleman

Merck and Schering-Plough Settle Class-Action Suits for $41.5 Million

David Mittleman — Sat, 15 Aug 2009 10:00:00 GMT

Merck & Co. and Schering-Plough Corp. have agreed to pay $41.5 million to settle class-action lawsuits over their cholesterol drugs Vytorin and Zetia. Specifically, the class-action lawsuits accused them of withholding unfavorable results of a clinical trial of the two drugs.

The companies released the results of the study—the Enhance clinical trial—in January 2008. Performed nearly two years prior to its release, the study indicated that the cholesterol drugs were no more effective in unclogging blocked arteries than other pre-existing and less expensive cholesterol treatments.

The settlement money will go to more than 140 claims filed by consumers and insurers who bought, used or paid money to purchase Vytorin and Zetia. However, Merk and Schering-Plough continue to defend the efficacy of the drugs and do not acknowledge any wrongdoing or liability as part of the settlement.

Originally posted at InjuryBoard by David Mittleman

Wyeth Paid Ghostwriters to Promote Hormone Replacement Therapy Drugs

David Mittleman — Mon, 10 Aug 2009 13:50:51 GMT

26 “scientific articles”, backing the use of hormone replacement therapy in women, were published in medical journals between 1998 and 2005. The articles are part of a series of a newly unveiled court documents that indicate that pharmaceutical-paid ghostwriters played a major role in pushing female hormone replacement therapy for various maladies such as aging skin, heart disease and dementia. The ghostwriters specifically emphasized the benefits, while deemphasizing the risks of taking hormone replacement drugs. Overall, the medical consensus published in the articles benefited Wyeth, the pharmaceutical company that paid a medical communications firm, Premarin and Prempro, to draft the articles. As a result of the positive consensus on hormone replacement therapy, sales of hormone drugs shot to nearly $2 billion in 2001.

However, the seeming consensus on the benefits of hormone replacement therapy fell apart in 2002 when a federal study on hormone therapy found that menopausal women who took certain hormones had an increased risk of invasive breast cancer, heart disease and stroke. Furthermore, a later study found that hormones also increased the risk of dementia in older patients. A judge ordered Wyeth to unseal their internal files as part of lawsuits over their hormone replacement drugs: the drug maker faces claims from nearly 10,000 women who say the medicines caused their breast cancer.

A majority of the ghostwritten papers were review articles, in which an article weighs a large body of medical reviews and offers a final conclusion based on the previous medical research. The articles appeared in 18 medical journals, including The American Journal of Obstetrics and Gynecology and The International Journal of Cardiology. The articles did not disclose Wyeth’s role in paying for the work and Elsevier, the publisher of some of the articles, stated that it was disturbed by the allegations of ghostwriting and plans to do an investigation of its own. Moreover, a spokesman for Wyeth alleges that the articles were scientifically accurate and that it is neither an uncommon or illegitimate practice for pharmaceutical companies to routinely hire medical writing companies to assist in drafting manuscripts.

Originally posted at InjuryBoard by David Mittleman

Tysabri: Multiple Sclerosis Medication Linked to 13th Brain Infection Case

David Mittleman — Tue, 30 Jun 2009 13:02:55 GMT

Biogen Idec Inc., a biotechnology company, announced Friday that another patient who was taking its Tysabri multiple-sclerosis medicine is infected with progressive multifocal leukoencephalopathy, or PML. Their announcement marks the 13^th case of the infection in patients taking Tysabri. Three other patients have already died from taking the medication and contracting PML. PML is a serious brain infection that attacks the central nervous system and damages and inflames the white matter areas of of the brain. Immune suppressing drugs such as Tysabri put patients at serious risk for contracting PML and potentially dying as a result.

Tysabri was pulled from the market back in 2005 after three initial cases of PML were discovered. After holding hearings on the drug’s risks and benefits, the Food and Drug Administration allowed Tysabri back onto the market in 2006 under new monitoring rules that the drug could not be combined with other MS drugs. The FDA had hoped that the new regulations would reduce the incidence of PML cases, but there have been ten new cases since.

Several other immune suppressing drugs have also contributed to the incidence of PML. In fact, Roche Holding AG pulled its psoriasis drug, Raptiva, over reports of PML. Similarly, Roche and Biogen has also come under increased scrutiny from the FDA over reports that its cancer treatment, Rituxan, increases the likelihood of contracting PML.

Originally posted at InjuryBoard by David Mittleman

Supreme Court Rules in Favor of Teenage Student in School Strip-Search Case

David Mittleman — Sun, 28 Jun 2009 12:38:50 GMT

June 25—The Supreme Court voted 8-1 that a teenage student’s Fourth Amendment rights were violated by the Safford Middle School when she was strip-searched in an attempt to locate prescription-strength ibuprofen. The school district bans prescription and over-the-counter drugs, and school officials suspected Savana Redding of harboring pills after a schoolmate implicated her.

To investigate the accusations, the vice principal ordered the girl, then thirteen, to his office, where he initially searched her backpack and found nothing. He then proceeded to take her to the nurses’ office, where the nurse told her to remove her pants and shirt and when they still found nothing, they ordered her to move her bra “to the side” and to stretch the elastic waistband of her underpants.

In the Court’s opinion, the school’s search of the girl’s backpack and outer clothing was permissible and consistent with their 20-year precedent that a school may perform searches based on reasonable suspicion. However, they stated that the school officials went “too far” when they asked her to remove her underwear because it was “excessively intrusive”. While the Court ruled that the school officials could not be held financially liable in a lawsuit for the search, the justices ruled that the school district itself may be held liable and sent the case back to the lower courts to complete litigation on that issue.

Justice Thomas was the sole dissenting vote on the question of the school board’s immunity, stating that he found the search legal and that the Court had previously given school officials “considerable leeway” under the Fourth Amendment in school settings. Justice David Souter, perhaps writing one of his final opinions as a Supreme Court Justice, wrote that the school district exceeded the Constitution’s limits because of the lack of “facts that pointed to Savana” being “any indication of danger to the students from the power of the drugs of their quantity” as well as the lack of “any reason to suppose that Savana was carrying pills in her underwear.”

Originally posted at InjuryBoard by David Mittleman

Lawsuit leads to lower prices for prescription drugs

David Mittleman — Sat, 13 Jun 2009 13:14:52 GMT

Consumers could see some relief from their prescription drug costs—the prices of hundreds of brand name drugs are about to be cut 4% and prescription drug users may soon receive a reimbursement check as compensation for overpayment on their medications.

The price cuts and the reimbursement checks are a result of a federal class action lawsuit against two drug-pricing publishers and a major drug wholesaler who are both being accused of artificially inflating drug prices. An economist, a witness for the plaintiffs, estimates a $1 billion savings the first year if the price cuts are implemented, with a savings of $100 million directly to consumers. These cost savings will have the most impact on the uninsured or underinsured, while the reimbursement checks will also primarily go to this group as well. Under the $350 million settlement, $60 million has been set aside as payouts for the uninsured and underinsured who purchased such drugs as Lipitor and Ambien, and hundreds of other drugs between August 2001 and January 23, 2009.

The settlement already has preliminary court approval. However, pharmacies and pharmacy-benefit managers are trying to stop the price rollbacks, in particular, which could shrink their profit margins. So far they have been unsuccessful in their appeals, as one of their motions was recently rejected by the federal judge overseeing the litigation in a U.S. District Court in Massachusetts.

Originally posted at InjuryBoard by David Mittleman