Senate Finance Committee member Charles Grassley, a Republican, in letters to Wyeth Pharmaceutical Company questioned its practices of ghostwriting contracts that produced medical journal articles favorable to hormone therapy, Prempro. Wyeth published one such article even after a federal study found the drug raised the risk of breast cancer. The letters from Senator Grassley asked that Wyeth and Design Wright disclose payments related to the preparation of journal articles and the activities of doctors who were recruited to put their names on them for publication.
Sadly, there have been practices in the past where medical articles have been signed by prominent physicians indicating that they believe that certain drugs are safe and beneficial to users, only to learn that "ghostwriters" had written the articles for the doctors. This is a situation where the pharmaceutical company hires these "ghostwrites" and then pays money to the ghostwriter and the physician to endorse the article and of course the product. This risks putting forth false and misleading information to the Food and Drug Administration as well as consumers who have been reassured that these are safe medical products. In this particular instance these articles deal with the use Prempro, which is a hormone therapy or hormone replacement drug for women where there is evidence that it causes an increase in the risk of breast cancer.
Christian & Davis believes that there needs to be greater accountability and that the Food and Drug Administration itself has failed in properly screening drugs. The Food and Drug Administration itself has allowed unsafe drugs with faulty medical research to enter the market causing harm to medical consumers.
More evidence of misbehavior and concealment by pharmaceutical companies has surfaced. Seroquel, a drug which was designed to help persons with psychological problems, has been identified as causing serious physical harm to many people. Recently an internal E-mail was unsealed as part of the litigation over the Seroquel drug. This E-mail revealed that AstraZeneca failed to publicize results of at least three clinical trials of Seroquel with less favorable results, but on the contrary "cherry picked" data from one of the studies which was more favorable. At present AstraZeneca faces approximately 9,000 lawsuits because it failed to properly warn users that Seroquel can cause diabetes and other health problems.
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In this day in age you can go online and rate just about anything you want. Some sites do a number rating system and others allow you to have a forum for what or who you are rating and why you are giving it or them the said favorable or unfavorable comments. There are at least three sites that allow you to do this forum style rating in the medial feild, Zagat's, Angie's List, and RateMDs.com.
There are Doctors that are requiring patients to sign a form stating that the patient will not post any material online that has a negative connotation to it, in relationship to the doctor or his or her place of practice. Doctors are essentially demanding a gag order on patients who are not happy with the service they receive at their doctor's office.
John Swapceinski, creator of RateMDs.com said, "They're (Doctors) basically forcing the patients to choose between health care and their First Amendment right, and I really find that repulsive!" A "Wall of Shame", naming all doctors who use patient waivers is in the works.
The question is for you as a patient is do you believe every thing you read online or do you take everything with a grain of salt and determine for yourself what is worthy of concern. Question the medicine not the wait in the lobby.
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Pfizer has set aside $2.3 billion for EXPECTED fines for illegal marketing practices for this coming year. Drug and medical device companies have been faced with greatly increase fines for illegal marketing tactics, over the past year. An illegal marketing tactic is when a company pays a doctor excessively to hock their product. The main issue is not that the doctors are being paid to sell products, the main issue is that the doctors are not educated on the overall value or usefulness of the products. We as patients are not holding them accountable to taking care of us when we are sick or injured. We assume that doctors know the best treatment for us, fact is some doctors take the word of the drug companies and the device companies that their product is ideal for you.
Much of the debate surrounds the manufacturers repeatedly giving consulting payments in illegal schemes to persuade doctors to prescribe drugs or devices in inappropriate and unapproved ways. Federal officials are planning on attacking the connection between the manufacturers and the people. Doctors are now the focus of the Federal Regulators, hoping to expose those that are excepting kickbacks from those manufactures and to hit them with heavy fine and possible jail time for essentially accepting bribes to prescribe particular products.
Federal Regulators will also be pushing for similar laws, which are already in place in Minn. Drug and device company's would be required to publicly post any payments to doctors over $500. This in Minn. has given way to hospital systems regulating themselves to a higher degree, in what is in and used within their systems.
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A spine surgeon who also performs research at the University of Wisconsin was paid $19 million over five years from Medtronic, Inc. while using its products on his patients. This activity was discovered by a senator who was investigating potential conflicts of interest in medicine and medical products research.
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In a related article the University of California at San Francisco questions the validity of medical journal publications concerning new prescriptions drugs which many doctors rely on. The drug companies are required to run numbers of tests on volunteer patients before seeking approval of the Food and Drug Administration. The companies typically sponsor reports of these tests in medical journal publications which doctors rely on to determine whether to prescribe new drugs for their patients. Now a skeptical team of medical investigators at UCSF have accused the major drug companies of being biased and distorting the results of those trials and their publications. This makes it difficult for doctors to fairly judge the pluses and minuses of prescribing such new drugs. An unfortunate result is that patients could receive medications they don't need or with unwanted and unanticipated side effects. UCSF reports that this unfortunately this leads to doctors prescribing medications without unbiased information before prescribing the drugs. Drug companies are required to post a broad range of ongoing clinical trials and comprehensive information about those trials on a registry maintained by the National Institutes of Health. This registry is located at http://www.clinictrials.gov/.
To support the finding that the medical articles may be skewed in favor of use of the drug, it was found that one-fourth of the results from trials testing the effectiveness of a drug were not published within 5 years after the FDA approval. This raises the concern that when the results were not positive they simply were not published. On the other hand drug trials showing "favorable results" were shown to be 5 times more likely to be published than trial results which show less favorable results.
Christian & Davis would emphasize to prescription consumers to be wary of the bias of the drug companies who have spent large sums of money developing drugs and who have a desire to introduce these drugs and sell them to the public. This is made more apparent to all of us by the commercials which are run on television encouraging us to ask our doctors for these new drugs which may or may not be safe or appropriate. If you find that you have taken a drug which has caused harm, it is certainly worth checking with Christian & Davis to determine if this drug is one which was properly tested before being introduced to the market. At present, President Bush's administration has pushed for a policy which would prohibit lawsuits against drug manufacturers for defective drug products if they were approved by the FDA. It is hopeful that the present Congress will change this so that mere approval by the FDA will not rob an injured person of their right to bring a lawsuit for a defective drug product where there is proof that there was not proper testing and warning.
