The world of hospitals, doctors, pharmaceuticals, and insurance companies can be wildly intimidating to those who are unfamiliar with it. Each player is financially invested in moving medicines and patients through the system efficiently, and it can sometimes feel that a patient is not being seen as an individual, but as a method of extracting profit. Women who have been treated for breast cancer with the chemotherapy drug Taxotere and subsequently suffered from unexpected, permanent hair loss may be understandably concerned that they were not informed of the risks involved with the drug. These women may be wondering, how did this information slip through the cracks?
Litigation on this issue is still pending, and only time will reveal why the common side effect of permanent hair loss from Taxotere was not disclosed to patients before they were given the drug. Currently, there are various possibilities, most notably that Sanofi-Aventis, the manufacturer, purposefully concealed information on this side effect to avoid a drop in sales. Another angle to take into consideration is that doctors may have known that permanent hair loss was a possibility, but since they were given information stating that Taxotere was more effective at fighting breast cancer and led to a higher rate of survival, the doctors still preferred to prescribe the drug. Taxotere's superiority has been disproven in multiple studies.
Troubling Relationship: Physicians and Pharmaceutical Companies
Yet a third factor that could possibly have contributed to permanent hair loss in thousands of women all over the country may be the relationship between doctors and pharmaceutical companies. It is no secret that doctors often receive payment from pharmaceutical companies for a variety of services that the doctor may provide. Pharmaceutical representatives work for the corporations and are tasked with bringing samples of medication and/or medical devices to large hospitals or private practices and convincing these medical organizations that their product is superior to those already in use.
Because there is such fierce competition between these multi-billion dollar pharmaceutical players, they must aggressively market their drugs in order to make the substantial profits they desire. Some argue that these profits are in fact necessary so that the companies have capital to invest back into research and development for new drugs. In addition, generic brands which contain the same chemical compounds as the brand name drugs are often available as alternatives for a fraction of the cost. Patients, for the most part, have the same experience with generics and brand names. In fact, in 2015, ProPublica produced a comparative study of patient experiences with generic and brand name drugs, finding no significant difference in quality or effects of a variety of drugs. Dr. Joseph Ross, an associate professor of medicine and a health policy researcher at Yale University School of Medicine, commented on these findings in an email:
“Generic medications are manufactured to be equivalent in all ways (except appearances) to brand-name medications. Unfortunately, many patients and physicians are convinced to spend more and use the brand-name medication by marketing initiatives, including advertisements on the television or drug coupons that promise similar out-of-pocket expenses for the higher-cost brand-name medications.”
It is true that both brand name and generic docetaxel (Taxotere) will cause permanent hair loss. However, one can see how aggressive pharmaceutical companies must be in marketing their product in order to maintain a dominant position in competitive markets, such as the chemotherapy market.
Common Physician Payments
There is a variety of ways that doctors can legally receive money from pharmaceutical companies. The corporations are allowed to provide free products to doctors and hospitals in the form of clipboards, tee shirts, pens, posters, and other day to day items. They also often provide doctors with free meals. In fact, meals are the most common form of payment. One analysis of the pharmaceutical company Amgen's payments to doctors found that “Food accounted for nearly 50,000 of Amgen's 55,000 payment reports, excluding research, in 2013, or roughly 91 percent. But at a cost of $3.1 million, those meals represented only about 20 percent of its payments.”
Although food is the most common form of payment, other kinds of payments can be significantly more lucrative for doctors. Pharmaceuticals can offer to pay for business travel, gifts, consulting on clinical trials, and even promotional speaking on behalf of their products. In some cases, these payments can run into the hundreds of thousands of dollars.
Lines between legal payments and illegal kickbacks can be messy. Doctors cannot be explicitly paid to prescribe particular prescriptions to patients. For example, it is illegal for doctors to accept money from pharmaceuticals in agreement to exclusively prescribe the company's blood pressure drug. However, it is not illegal for the same doctors to receive thousands of dollars in “consulting fees” from the drug company and, simultaneously, happen to exclusively prescribe the company's blood pressure drug.
Physician Payment Sunshine Act
The Physician Payment Sunshine Act, commonly referred to simply as the “Sunshine Act,” was part of the 2010 Affordable Care Act. The act was designed to increase access to information about the relationships that physicians and hospitals have with pharmaceutical companies and medical device manufacturers. Under the act, pharmaceutical and related medical companies must submit information to the government annually which lists all payment made to medical practices and doctors. After the report is submitted, doctors have 45 days to review the information and dispute any claims with which they do not agree. The information is then compiled into a database and released to the public. The first reports produced by the Sunshine Act were released in 2014 and covered the last five months of 2013.
Now, the government provides access to a website called Open Payments which “collects information about the payments drug and device companies make to physicians and teaching hospitals for things like travel, research, gifts, speaking fees, and meals.” The website also provides data on physicians who might have a financial interest in the success of pharmaceutical companies.
Before the Sunshine Act, most of the transactions between medical companies and practicing physicians were kept secret and conducted behind closed doors. ProPublica, an independent journalism nonprofit based in New York, had been running a database of pharmaceutical payments to doctors since 2010 called Dollars for Docs, but their sources of information were quite limited. The only information which journalists and patients previously had access to came from seven companies, “most of which were required to report their payments publicly as a condition of legal settlements.”
Now, Propublica's online database has become much more extensive and up-to-date. On their website, you can search by doctor, hospital or medical company to find information about money given and received by each party in the past couple of years. They also provide tips to patients who wish to speak to their doctors about concerns they might have about their physician's prescribing practices.
Statistics on the ubiquity of this practice can be alarming. Various studies between 2000 and 2010 place the number of physicians with ties to pharmaceuticals or medical companies at around 75% of the “estimated 800,000 to 900,000 active doctors in the United States.” This number is decreasing as companies try to target specific doctors instead of implementing a blanket approach. For example, well-known physicians and researchers are particularly targeted, like “Dr. Marc Cohen, chief of cardiology at Newark Beth Israel Medical Center” who “received more than $270,000 last year for speaking or consulting for six companies listed in Dollars for Docs. Even smaller companies are shown to spend millions on speaking fees. One company, Forest Labs, spent $32.3 million on speaker fees in 2013 alone, according to ProPublica.
If there was any question about whether or not this practice influenced doctors to prefer prescribing one medication over another, Propublica published a study in 2016 in which they “analyzed the prescribing patterns of doctors who wrote at least 1,000 prescriptions in Medicare's drug program.” They most likely used information from the Medicare program because it is easier to access, as opposed to private insurance records. The analysis showed that doctors who were given payments of any kind by a pharmaceutical or medical company were more likely to prescribe that company's drug. Even receiving a meal from a company made them more likely to prescribe the drug.
Higher payments were also associated with a higher rate of prescription. Doctors who were paid more that $5,000 in cash and other gifts were anywhere between 5% and 28% more likely to prescribe the drug produced by the company which paid them. As an example, “Among internists who received no payments, for example, the average brand-name prescribing rate was about 20 percent, compared to about 30 percent for those who received more than $5,000.”
Taxotere-Related Payments by Sanofi-Aventis
Sanofi-Aventis is the main producer and marketer of the brand name chemotherapy drug, Taxotere. It is difficult to know at this point in the legal battle against the pharmaceutical if illegal kickbacks contributed to high prescription rates of Taxotere as compared to other, closely related taxane drugs. However, there is currently a case moving its way through the court that alleges exactly that. The federal government is suing Sanofi-Aventis after a whistleblower, Mr. Yoash Gohil, who formerly worked for the company, came forward with information about the company's practices in the late ‘90s. At that time, Taxotere had not been approved for use in many cancers for which doctors were prescribing it. He claims that this practice occurred because “the company paid health care providers in illegal kickbacks to promote its off-label use. They were rewarded with sham unrestricted grants; speaking fees; entertainment, sports and concert tickets; free samples; and free reimbursement assistance.”
According to ProPublica's database, Sanofi-Aventis distributed $30.1 million to 126,439 doctors in the United States between August 2013 and December 2015. During the same period of time, they paid almost $93,000 to doctors in promotions associated with Taxotere. Extrapolating from this data, if Taxotere was first marketed in the late ‘90s, hundreds of thousands, if not millions, of dollars have been spent promoting the drug.
Fox Chase Cancer Center
It may be tempting to pretend that these practices do not affect us or our loved ones; that the doctors we see are impartial, objective, and dedicated to putting our physical, mental, and financial well-being before their own financial interest. While there are hundreds of doctors who do have these priorities, even in Pennsylvania there are facilities which permit high levels of payments from pharmaceuticals which have the power to potentially influence doctors' courses of treatment.
For example, in 2016, the Philadelphia Inquirer published an analysis of the Propublica data showing that 92% of doctors at Fox Chase Cancer Center in Philadelphia had been given payments by pharmaceuticals, the highest percentage in the Philadelphia area. In addition, “Fox Chase, which ranked 10th nationally for its percentage of affiliated doctors receiving payments of any size, also had the region's highest percentage of doctors who collected at least $5,000.” The chief academic and administrative officer said that the majority of these payments were made in the form of lunches provided by pharmaceutical companies during unrelated conferences. As the research shows, however, even a lunch under $20 can increase a physician's tendency to prescribe a drug.
The Next Step for Taxotere Victims
When people go to the doctor's office, they often feel extremely vulnerable. If they are living with and fighting a disease like cancer, they may feel even more susceptible to the suggestions and advice of their physicians because they feel that their life depends upon it. Because of this, doctors hold an incredible amount of power over their patients and should use that power in the best interest of their patients. Unfortunately, some doctors may not even realize the influence that pharmaceutical payouts have on their ability to be objective in treating a patient.
If a doctor has prescribed you Taxotere in the treatment of your breast cancer, and you have experienced the common side effect of alopecia, you may be feeling betrayed by the people and institutions that you trusted to guide you through your illness. To take the next step, consider filing a lawsuit against the company which claimed Taxotere's superiority and marketed the drug aggressively to doctors as a superior option to other taxane chemotherapies. Sanofi-Aventis, Inc. is currently facing over 900 lawsuits from women all over the country who have chosen to speak up and make their voices heard.