It was at Thanksgiving time last year that Kathleen Thoren, a 25-year-old mother of three, died after days of severe headaches that, according to the medical examiner, were provoked by hormones released into her system by Ortho Evra — the once a week birth control patch.
In 2005 alone, about one dozen women died from blood clots believed to be related to Ortho Evra with dozens more surviving strokes and other clot-related problems. These women were largely young and not at risk for clots. Women like Zakiya Kennedy, an 18-year-old Manhattan fashion student who collapsed and died in a New York subway station in April 2004, and Sasha Webber, a 25-year-old mother of two who died of a heart attack after six weeks on the patch.
The Associated Press analyzed federal drug safety reports, finding that women using the patch are at a triple risk of dying or suffering a survivable blood clot compared to women using birth control pills.
The US Food and Drug Administration (FDA) approved Ortho Evra in November 2001 as the first birth control skin patch. But long before the patch reached the marketplace in 2002 both the FDA and Ortho McNeil, the Johnson & Johnson company that manufactures Ortho Evra, saw warning signs of possible problems. The FDA had already noticed that nonfatal blood clots occurred three times more frequently than the pill. Blood clots in the lungs were seen in two women given Ortho Evra in clinical trails conducted before the drug was approved – in addition to many similar cases in women after the drug was marketed. According to Public Citizen, drugs rarely present such strong evidence of a serious problem during randomized pre-approval studies.
Ortho Evra contains two hormones: an estrogen and a progestin. Most pills and the patch contain the same amount of estrogen, but hormones from the patch go straight to the bloodstream while pills are swallowed and digested, losing half the estrogen dose. Women using the patch are exposed to high levels of estrogen 24 hours a day. Associate Professor of Obstetrics and Gynecology at the University of Washington, Dr. Leslie Miller has reported that women using the patch absorb significantly more estrogen than the pill, adding the elevated levels may be high enough to increase some women’s risk of blood clots.
On November 10 the FDA updated labeling for the Ortho Evra birth control path to warn healthcare providers and patients that this product exposes women to higher levels of estrogen (about 60 percent more) than the pill. But not all physicians waited for the new label to take action. In October, Dr. Miguel Cano, an obstetrician and gynecologist in Reedley, California, sent a note to several thousand patients recommending that the stop using the patch and that they come in for appointments to get a new form of contraception. On the website worstpills.com Public Citizen proclaims: “There is no medical reason for women to use the more dangerous Ortho Evra rather than one of the older, better understood, and equally effective oral contraceptives.” Public Citizen’s Health Research Group added Ortho Evra to its ongoing list of dangerous medicines.
Catchy ads featuring Olympic beach volleyball players and supermodel Namoi Campbell — resulted in more than five million US women trying the patch in less than three years. In 2004 Ortho Evra sales topped $411 million for 9.9 million prescriptions, accounting for 15 percent of the US market. In July 2005 J & J CFO Robert J. Daretta reported no sign of increased safety problems with the Ortho Evra birth control patch. Obviously Mr. Daretta did not foresee the increased label warnings.

On November 10, 2005 the FDA issued an “updated lablelling” concerning possible adverse health effects of using the Ortho Evra birth control patch. Here is the warning issued by the FDA:
The Food and Drug Administration today approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare providers and patients that this product exposes women to higher levels of estrogen than most birth control pills. Ortho Evra was the first skin patch approved for birth control.
It is a weekly prescription patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the blood stream. FDA advises women to talk to their doctor or healthcare provider about whether the patch is the right method of birth control for them.
Furthermore, women taking or considering using this product should work with their health care providers to balance the potential risks related to increased estrogen exposure against the risk of pregnancy if they do not follow the daily regimen associated with typical birth control pills. Because Ortho Evra is a patch that is changed once a week, it decreases the chance associated with typical birth control pills that a woman might miss one or more daily doses.
The addition of this new warning is a result of FDA’s and the manufacturer’s analysis directly comparing the levels for estrogen and progestin hormones in users of Ortho Evra with those in a typical birth control pill. In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious adverse events.
The new bolded warning specifically states that women who use Ortho Evra are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill containing 35 micrograms of estrogen. However, the maximum amount of estrogen to which women are exposed is about 25% lower with Ortho Evra than they are with typical birth control pills.
FDA is continuing to monitor safety reports for the Ortho Evra patch. The manufacturer, Ortho McNeil Pharmaceuticals is conducting additional studies to compare the risk of developing serious blood clots in women using Ortho Evra to the risk in women using typical birth control pills that contain 35 micrograms of estrogen.
The new labeling information is available along with additional information for healthcare providers and consumers online at: www.fda.gov/cder/drug/infopage/orthoevra/default.htm

According to an article published in the Wall St. Journal, researchers and physicians who write the rules on prescribing drugs have extensive financial interest in the pharmaceutical industry. The study undertaken by Nature revealed that more than 1/3 of the authors writing the prescription guidelines had substantial links to the relevant drug companies. In one case, every panel member charged with writing such guidelines had been paid by the company manufacturing the drug. Public health officials say the links with pharmaceutical links are more worrying than the financial conflicts known to plague clinical trials and reviews because the guidelines have such a direct effect on the drugs that doctors prescribe. This conflict of interest is a huge public health hazard and once again demonstrates the industry’s need to be monitored by an independent agency whose only compelling interest is the welfare of the public.

New Jersey Superior Court Judge Carol Higbee ordered the testimony of Briggs Morrison, a Vice President for Merck Research Labs to be stricken from the record and ignored by the jury. “Quite frankly, I felt sick yesterday afternoon,” she said. “I realized how I have got sucked into this. I feel that I was misled during the testimony.” The comments came on the heels of Merck testimony about a series of animal tests and their implications for the safety of Vioxx, but the judge said he was not an expert on the topic. The judge ordered that the entire testimony be ignored by the jury and that if Merck wished to use him as a witness any further, the company’s defense lawyers would have to rely on testimony given during an earlier videotaped deposition. Merck attorney Diane Sullivan protested the judge’s ruling but was repeatedly told by the judge to sit down and stop speaking. The judge at one point threatened to remove Sullivan from the courtroom after the lawyer continued to argue against the judge’s decision.

A top Merck executive testified yesterday that the Vioxx manufacturer feared as much as a $500 million drop in sales if regulators had succeeded in placing an unfavorable warning on the Vioxx label three years ago. David Anstice,who headed Merck’s US marketing campaign at the time, admitted an internal Merck memo showed the company feared a huge drop in sales if the FDA won its battle over the Vioxx label.

An expert witness testified Thursday that even short term use of the painkiller Vioxx can double the risk of heart attach and death, a finding that the drug’s manufacturer Merck & Co. misrepresented. University of Washington biostatistician Richard Kronmal said company sponsored tests showed that patients who took the drug suffered serious side effects to blood vessels amost immediately. After reviewing Merck’s own data, Kronmal stated, “It clearly is a drug that has severe effects on the vascular system.”

As the second week of the nation’s second Vioxx trial prepares to open in New Jersey this week, Merck’s lawyers continue their obfuscation and “don’t confuse me with the facts” campaign. Last week, Merck’s lead lawyer was reprimanded by the judge for bashing her fellow colleagues as well as trying to mention that Merck pulled the Vioxx drug off the market. On Thursday, Judge Higbee barred the Merck lawyers from making reference to Vioxx being pulled from the market. The judge noted that such information was irrelevant to the case since the plaintiff had suffered a heart attack prior to Merck’s withdrawal of Vioxx.

One week before its second trial is about to begin, Merck lawyers are trying to block jurors from seeing the following information: 1)FDA researchers estimated Vioxx deaths, 2)Picture of the plaintiff prior to taking Vioxx, 3)Merck’s profits, and 4)Merck executives’ salaries. In their ongoing campaign of disinformation, Merck is more interested in profits than public safety. However, there may be serious consequences to their behavior. In Texas, the state itself contends that Merck defrauded it out of hundreds of millions of dollars in Medicaid payments. While Texas is the first state to take this extraordinary step, it probably won’t be the last. In addition, to $168 million in damages, Texas is seeking additional civil penalties. Texas Attorney General Greg Abbot believes the state can prove total damages in excess of $250 million including triple reimbursement of $56 million for five years of filled Vioxx prescriptions. It is estimated that 700,000 Vioxx prescriptions were filled through Medicaid during those five years in Texas alone. According to the Attorney General, this is “a prime example of a company’s drive for profit steamrolling its duty to be safe.”

In the wake of Merck’s disastrous first trial in Texas last month, the embattled pharmaceutical company faces a trial in New Jersey that involves a plaintiff that suffered a heart attack which is precisely the injury to which Vioxx use was linked. In another setback for Merck, New Jersey Superior Court Judge Carol A. Higbee, who is presiding over 2,475 Vioxx cases filed in New Jersey, refused to grant Merck an adjournment of the trial now scheduled for September 12. There is very little that favors the drug giant in this trial and many experts believe that another loss would make it virtually impossible for Merck to scare victims into small settlements.

In an abrupt turnaround from its previous stance, Merck & Co. spokesman Kent Jarrell told the Associated Press today that it might consider settling some of its lawsuits. However, the company continues to insist it won’t enter into any type of global settlement. Perhaps as more bad facts surface surrounding Vioxx, they may change their opinion once again.