Imagine beating breast cancer then finding out your hair would never grow back after your chemotherapy treatments–a small price to pay for your life, right? Imagine finding out there was another option, a less toxic drug that was just as effective but without the risk of permanent hair loss. That was the scenario thousands of women faced after taking the drug Taxotere to fight their breast cancer.
Taxotere is a potent chemotherapy drug marketed as a safe and effective treatment for women with certain types of breast cancer. Taxotere, also known by its chemical name docetaxel, belongs to a class of drugs called taxanes; it is effective against certain breast, lung, and prostate cancers. It is also extremely toxic.
Chemotherapy is known to cause hair loss in the majority of patients who undergo treatment. In most of these cases, the patient’s hair grows back. But this isn’t every survivor’s story. Many patients treated with Taxotere suffered permanent hair loss as a result of the drug, forcing them to live with the constant reminder of chemotherapy.
Former Taxotere patients who suffered permanent hair loss after treatment have spoken out against the manufacturer of the drug, french pharmaceutical giant Sanofi. They have spoken out on blogs and social media, saying had they known the risks of Taxotere and had they known there were alternative treatment options, they would have chosen a different drug.
Not only are women speaking up online, they’re taking a stand against Sanofi in the courtroom. Thousands of women across the country have filed Taxotere lawsuits against the pharmaceutical company, claiming the drug caused permanent hair loss. The lawsuits allege Sanofi used deceptive marketing tactics to sell a defective drug, and accuse the company of hiding evidence that proved Taxotere was not as effective as the company claimed.
Taxotere isn’t the only chemotherapy drug approved to treat breast cancer. There is another taxane drug available that many women say they would have chosen over Taxotere had they known it was an option, and had they known the risks of Taxotere.
Hair loss may be a small price to pay for live-saving chemotherapy, but it shouldn’t have to be permanent. Breast cancer survivors didn’t sign up for a treatment that would brand them forever.
Is Taxotere as effective as Taxol? Sanofi certainly thinks so. The company boasted Taxotere was not just as effective as Taxol, it claimed Taxotere was superior to Taxol. A 2005 study funded by the drugmaker and published in the Journal of Clinical Oncology found Taxotere was more effective in treating women with advanced breast cancer than the competitor Taxol. The results of the study showed women who used Taxotere as part of their chemotherapy treatment lived about 2.5 months longer than women who used the competing drug Taxol.
The results of this study, however, may have been overstated. No other clinical trial has been able to replicate the results and the U.S. Food and Drug Administration itself said the trial’s claims were overstated.
Taxol, or paclitaxel, belongs to the same class of drugs as Taxotere but studies show it is less potent than its counterpart. Even the 2005 Sanofi-funded study found Taxotere was more toxic than Taxol. This could explain why Taxol has not been associated with permanent hair loss — unlike Taxotere. Some studies estimate permanent hair loss can occur in up to 10 to 15 percent of breast cancer patients who use Taxotere. That is a significant portion of patients who may not have had all the facts they needed to make informed decisions about which chemotherapy treatment was best for them.
Sanofi touts that Taxotere is as safe as and even more effective than Taxol; yet its own study found Taxotere was much more toxic than its competitor. Many women treated with Taxotere who now live with permanent hair loss say they were not informed that there were other effective treatment options available.
They also say they were not informed of the risks associated with Taxotere, since Sanofi does not warn about permanent hair loss on its label. Had these women known such important information as risks and alternatives, they could have made informed decisions about what medication they would use in their treatments and they may not be suffering from permanent hair loss like they are today.
It is not unheard of for a pharmaceutical company to hide evidence from regulators, or simply “fail to report” it. The U.S. Department of Justice has tried and convicted dozens of pharmaceutical companies for hiding risks, using deceptive marketing practices, even paying kickbacks to doctors to sell more of their products. Some of the biggest pharmaceutical companies in the United States–and the world–have been found guilty of these acts and forced to pay millions, sometimes billions, of dollars in fines and settlements.
Lawsuits involving Taxotere accuse Sanofi of hiding evidence of the drug’s hair loss risk. One of the first lawsuits filed against the drug company alleged that Sanofi knew Taxotere was more dangerous than its competitors and frequently caused permanent hair loss. The lawsuit was filed by Ami Dodson, a California resident, in March 2016.
The suit accused Sanofi of withholding evidence of studies from the FDA, patients, and physicians that showed Taxotere was no more effective than its competitors—a claim Sanofi actively promoted in its advertising in the past.
The lawsuit also claimed Sanofi participated in a years-long scheme to drive up Taxotere sales and paid kickbacks to doctors to persuade them to prescribe the drug for off-label purposes.
“Defendants [preyed] on one of the most vulnerable groups of individuals at the most difficult time in their lives,” Dodson said. “Defendants obtained billions of dollars in increased revenues at the expense of unwary cancer victims simply hoping to survive their condition and return to normal life.”
Dodson said women may have accepted the possibility of permanent baldness if no other product were available to treat their cancer, but that was not the case with Taxotere. Similar drugs were already on the market and they were just as effective as Taxotere. They also didn’t expose women to the same risks of permanent hair loss, said Dodson.
Sanofi isn’t the first pharmaceutical to be accused of putting profits over people. Some of America’s most beloved companies have paid hefty fines for criminal and civil acts that steal money from the nation’s taxpayers. Companies like Johnson & Johnson have paid some of the largest settlements to the Department of Justice in recent years to settle allegations of fraud, illegal kickbacks, and deceptive marketing.
Sanofi is no different. In December 2012, the company agreed to pay $109 million to the Department of Justice to settle allegations it violated the False Claims Act by giving away free products to physicians.
A lawsuit filed by the DOJ against Sanofi revealed the company offered free units of the knee injection Hyalgan after facing pressure from a lower-priced competitor. The lawsuit alleged Sanofi sales representatives entered into illegal sampling arrangements with physicians, using the free units as kickbacks.
In response to the settlement, United States Attorney for the District of Massachusetts Carmen M. Ortiz said:
“The government’s allegations describe a situation where a drug manufacturer used valuable free units of a drug to subvert Medicare’s drug reimbursement system for physicians. … This is not the first time that this Office has brought action against a manufacturer who engaged in such an illegal scheme, and the government will remain vigilant in policing such conduct.”
Sanofi’s fraudulent behavior didn’t stop there. In April 2017, the DOJ announced Sanofi Pasteur, the vaccines division of the pharmaceutical giant, would pay another $19.8 million to resolve allegations. This time, the company was accused of overcharging the Department of Veterans Affairs (VA) by incorrectly calculating drug prices for two separate contracts, a 2002 contract and a 2011 contract.
In addition to these settlements, Sanofi has been accused by the Food and Drug Administration of disseminating misleading Taxotere ads. The federal agency chastised the drugmaker for distributing a reprint of an article that describes a study regulators say overstates the effectiveness of Taxotere.
The article claimed Taxotere was superior to Taxol, but the FDA said such a statement needs to be supported by two well-designed clinical trials and said it wasn’t aware of any study that reproduced the results from the trial cited in the article.
These incidents highlight the ethical questions that surround pharmaceutical companies like Sanofi, and confirm the idea that these corporations place their own profits far above the people whose lives they’re supposed to be improving.
Sanofi was put on notice in February 2017 when French regulators announced an investigation into Taxotere after five women died from complications related to the drug.
In a safety letter issued by France’s National Agency for the Safety of Medicines and Health Products, the agency said it knew of six incidents of a serious complication occurring in women treated with Taxotere for breast cancer. The complication is known as neutropenic enterocolitis and five of the six women died as a result of their condition.
A day after the agency issued the letter, it announced new recommendations regarding Taxotere. The agency said it no longer recommended Taxotere to treat localized, operable breast cancer and cited Taxol as a good alternative for patients.
Meanwhile, lawsuits continue to be filed against Sanofi in the United States.
The breast cancer drug Taxotere has been linked to cases of permanent hair loss and its manufacturer, Sanofi, is facing thousands of new lawsuits accusing the company of concealing the risk.
Women who underwent chemotherapy with Taxotere to treat breast cancer and are now experiencing permanent hair loss may be entitled to financial compensation. There may be significant payouts or cash settlements for those affected by the drug.
Taxotere lawyers and attorneys are actively accepting cases nationwide from women harmed by the medication. Taxotere lawsuits accuse Sanofi of several legal claims, including:
Taxotere lawsuits were consolidated into a multidistrict litigation, or MDL, in October 2016 by the Judicial Panel on Multidistrict Litigation. The cases were centralized in the U.S. District Court for the Eastern District of Louisiana before U.S. District Judge Lance M. Africk. At the time, there were about 89 lawsuits pending in the litigation. About a year later, in November 2017, there were over 2,300 lawsuits involved in the MDL.
MDLs help speed up the litigation process by bringing similar lawsuits together in one court. Attorneys on both sides are able to collaborate during the discovery process, which saves time and resources. A few cases are usually picked to be tried first. These are called bellwether trials. Bellwether trials give attorneys the chance to test out legal theories before a jury and can help inform settlement negotiations.
Verdicts or settlements awarded in an MDL are handed down individually in each case. This means global settlements are not split equally among all plaintiffs, like in a class action lawsuit. Instead, they are distributed among plaintiffs on a case by case basis and are often determined by the extent of the plaintiffs’ injuries.
As potent as Taxotere is, it’s no surprise the drug carries a black box warning and has been the subject of numerous safety warnings since it was approved in 1992. The FDA has issued several communications regarding the drug over the years, including updated labeling warning about the risk of permanent hair loss.
Black box warnings are the strongest warnings issued for pharmaceutical drugs. The warnings are placed prominently on a drug’s label and highlight severe risks associated with the product.
Taxotere’s label includes a large black box warning that lists several risks associated with the drug, including:
In 2015, the FDA added new information about permanent hair loss to the Taxotere label.
The agency said cases of permanent hair loss had been reported in postmarketing experience and the information was added to the adverse reactions section on the Taxotere label.
The agency did not include any additional information about the risk of permanent hair loss, such as the percentage of patients thought to be affected by the side effect.
The FDA has required numerous changes to the Taxotere label over the years. Many of these changes included additional safety information regarding potential Taxotere side effects, including:
The FDA sent out a warning about Taxotere in 2014 saying the drug could make patients feel drunk during or after treatment, since the drug contains ethanol, a type of alcohol. The agency told patients to avoid driving after their treatments and said medications like pain relievers and sleep aids could worsen the intoxicating effects. Sanofi updated Taxotere’s label to warn of the risk and physicians were advised to consider the alcohol content when prescribing Taxotere.
Taxotere is a popular chemotherapy drug used to treat breast cancer. Each year, about 260,000 new cases of breast cancer are diagnosed in the United States and Taxotere is used in a majority of the treatments. The drug has brought in billions of dollars for its manufacturer, Sanofi, since it hit the market a quarter of a century ago.
Taxotere was approved in 1992 after receiving priority review by the U.S. Food and Drug Administration. In addition to treating breast cancer, Taxotere can also treat some lung cancers, advanced stomach cancer, head and neck cancers, and prostate cancer.
Sanofi has marketed its potent chemotherapy drug as a more effective treatment over other FDA-approved drugs—marketing tactics that have not passed FDA muster. The agency has warned Sanofi about misleading consumers and making false claims in their advertisements in the past.
Studies have also linked Taxotere to increased risks of permanent hair loss, a side effect Sanofi claimed was rare.
Now, women who are living with the consequences of their chemotherapy drug are filing lawsuits against Sanofi. They accuse Sanofi of designing a defective product and failing to warn about its potential risks. Some lawsuits accuse Sanofi of covering up trial results that linked the drug to the risk of permanent hair loss and claim Sanofi engaged in a long-running scheme to drive up prices at the expense of cancer patients.
Taxotere is a potent chemotherapy drug and, like all chemotherapy drugs, carries the risk of a number of side effects. Some of these side effects include low blood cell count, infections, muscle pain, fatigue, and of course hair loss.
Though these side effects are common, they are only supposed to be temporary. Some women find that not to be the case when it comes to hair loss.
Like all chemotherapy drugs, Taxotere can cause patients to lose their hair during treatment, a condition known as alopecia. Sanofi’s potent drug, however, has been linked to cases of permanent alopecia. In these instances, the patient’s hair doesn’t grow back for several years or decades—if ever. And Taxotere doesn’t just affect the hair on the head. Women have reported losing their eyebrows, eyelashes, and even nostril hairs after using Taxotere.
Permanent hair loss can be devastating for breast cancer survivors who feel their quality of life has forever been impacted by this one drug. Sanofi lists permanent hair loss as a possible risk on the Taxotere label, but says hair “generally grows back.” The company estimates that about 3% of Taxotere users could lose their hair, but studies show that number could be much higher.
A study conducted by the Rocky Mountain Cancer Center in Colorado, for example, found 6.3% of patients experienced permanent alopecia after using Taxotere with other chemotherapy drugs — 2x the number of patients estimated by Sanofi. In another study, a UK survey of Taxotere patients found 15.8% had experienced permanent alopecia after using docetaxel, the generic version of Taxotere.
The FDA warned about the risks of permanent hair loss in 2015 and updated the drug’s label in after receiving reports of postmarket adverse events. These actions were a little too late for thousands of women who took Taxotere to fight their breast cancer and suffered permanent hair loss as a result.
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