| Duract, a painkiller made by wyeth and approved in 1997, is a textbook case of what might be called "too many open doors" at the FDA, and for the wrong kind of drug. There were twenty other analgesics already on the market when Duract was approved, and the senior reviewer at the agency, while he thought the drug worked well at relieving pain, was worried about the fact that many patients in the clinical trials had tested positive for elevated liver enzymes. |
| As sales took off late in 1997, wyeth detailed physicians heavily. Soon pharmacists were swamped with orders for Duract. Yet when they asked customers if they knew anything about the recommendation that they get their liver enzymes tested regularly, most were clueless. The result was catastrophic. Within a year, there had been four deaths linked to Duract-induced liver failure and eight liver transplants. In June 1998, less than a year after approval, Duract was pulled from the market. |
| As Gail Ludmeyer, the head of Wyeth's women's health initiative, explained, "Traditionally, women are seekers of information, but now they are barraged, and more confused than ever. We need to give their physicians information to un-confuse them." One way to do that was to recognize, as Pfizer's Ruth Merkatz said, that "women are logically emotional. |
Kelly Patricia O'Meara
See book keywords and concepts |
 According to a "Dear Health Care Professional" letter distributed by wyeth to U.K. physicians, "safety and effectiveness in pediatric patients (individuals below 18 years of age) have not been established. In pediatric trials, there were increased reports of hostility and, especially in Major Depressive Disorder, suicide-related adverse events such as suicidal ideation and self-harm." Effexor has not been approved by the FDA for use by adolescents suffering from depressive disorders. |
Ray Moynihan and Alan Cassels
See book keywords and concepts |
 Following those initial cancer findings, a second drug called progestogen (or progestin) was added to estrogen, to make a combined form of hormone replacement therapy, sold by wyeth as the popular Prempro with the promise of being safer than estrogen alone.
By the late 1980s and into the 1990s millions of women worldwide would start taking this combination hormone replacement therapy—or HRT—promoted on the basis of evidence suggesting that not only could it help relieve symptoms, but that in the long term it might reduce a woman's risk of bone fracture, heart disease, and cognitive decline. |
Gina Kolata
See book keywords and concepts |
 But wyeth lost and was ordered to pay $200,000 to the child's family. wyeth appealed to the Supreme Court, but the Court refused to hear the case and the judgment against the company held.
Neustadt and Fineberg, in their postmortem on the swine flu affair, tartly summed up what the Reyes case meant to vaccine manufacturers. The courts had ruled that wyeth had failed to adequately warn of its vaccine's dangers. "Never mind that the company had included in cartons for shipment a printed form which did contain adequate warning. |
Peter Rost
See book keywords and concepts |
 David Cay Johnston and Melody Petersen from the New York Times described what happened: "A former international executive for wyeth, the big drug company, uncovered a worldwide practice of cheating foreign governments out of taxes, only to be demoted after notifying senior executives, according to documents in a state lawsuit he filed against the company." Since I don't want to comment directly on this situation, I'll simply tell you what the New York Times wrote. |
| They especially noted that I worked at Pharmacia, that Fred Hassan was Pharmacia's CEO, and that Fred used to be a high-level executive at wyeth until he left in 1997. I was, of course, well aware of all those facts and I was only surprised that the U.S media didn't make more of this.
The journalist ended the article, "It is not a far-fetched guess that this drive by the authorities and media will also catch the scent of Pharmacia CEO Fred Hassan, who is just waiting for the cartel supervisors in Brussels and Washington to approve Pfizer's takeover of Pharmacia. |
| But I had concluded that this was the only way to win against wyeth, and, once I started thinking in those terms, I focused on that short-term objective. I also gambled that Pfizer wouldn't be foolish enough to try to immediately dismiss an employee surrounded by a team of lawyers.
I realized that the article would set off warning bells around Pharmacia, so I immediately contacted Fred Hassan and his direct reports. This wasn't easy or pleasant, but I had started a dangerous process and I needed to do what I could to ensure things didn't spin out of control. |
| According to the article, the president of a wyeth affiliate in a foreign country died on a Saturday night after slipping and falling from his 1 ltn-floor apartment. The newspaper article said that the 57-year-old fell off the balcony's railing while tending to his potted plants. Detectives had also "ruled out the possibility that the executive was murdered, finding no signs of trauma on his body caused by external forces."6
The article went on to say that the man's wife and son were inside the apartment when the incident occurred. |
| A number of individuals on Wyeth's Yahoo message board picked up on this article. One was so funny that I forwarded it to Pfizer's management. It said "Former WYE executive now works for PFE!!! That tells me that PFE must be an ethical company!!!"2 When I recently went back to check that message again, it had been deleted. But I had already saved it on my computer. Funny how many interesting documents and messages kept disappearing around me.
As October passed, the leaves outside my office window vanished, and so did my former coworkers, one by one. |
Joseph E. Mario
See book keywords and concepts |
 Test for sensitivity to Wyeth's polyvalent Crotalidae antivenin made from horse serum. Use a poultice of crushed Onion with a few drops of kerosene to draw the green toxins. Fresh Echinacea root (Sioux). Simmer 1 ounceofPlantainrootorflowersinapintofwaterfortenminutes; strain. cool, and apply topically. Use Hartshorn/ Ammonia spiritsexternallyto neutralize the poisons betterthan caustic. Saltpeter a specific, 1 tbs. in water int., and as poultice. 1 tsp. for children. |
| Elapidae cobras and coral snakes (Micruruns fulvius) envenomate by slow chewing (if yellow rings are separated by black, it is a non-poisonous king snake); symptoms do not appear for some time, then set in so quickly, it is best to sensitize and take Wyeth'santivenin upon beingbitten.
The king cobra/hamadryad/Naja Hanah in India, in Burma/Myanmar, Southeast Asia, and the Philippines; is the largest and most deadly venemous snake known, grows up to 18.3 feet long. Has long fangs injecting venom that can kill a 6-ton elephant in 3 hours. |
Katharine Greider
See book keywords and concepts |
 Notwithstanding protests from animal-rights groups, wyeth even managed to turn to its advantage the fact that its Premarin-family products are derived from the urine of pregnant mares, convincing the FDA, with the help of women's groups, not to approve a plant-based generic on the grounds that it was missing a key ingredient whose significance no one seemed able to identify. According to a recent report in
Business Week, the Premarin family came to account for 15 percent of Wyeth's sales, and as much as 30 percent of its profits. |
Dr. Timothy Scott
See book keywords and concepts |
 It simply states, "Effexor® XR (venlafaxine HC1) Extended-Release and Effexor Immediate-Release Prescribing Information, wyeth Pharmaceuticals, Inc. Philadelphia, Pa."
Bottom line: This ad does not reference even one published article indicating that their drug works. And yet this is one of, if not the single most seen drug ad in the world's top medical journals in the last two years.6
Not Unique
Unfortunately, the Effexor ad is by no means unique. I have investigated a number of these ads recently and found that the research behind most of the mind drug ads I checked was just as phony. |
Gina Kolata
See book keywords and concepts |
| The courts had ruled that wyeth had failed to adequately warn of its vaccine's dangers. "Never mind that the company had included in cartons for shipment a printed form which did contain adequate warning. Never mind that experts had testified at trial that this particular case was not vaccine-related. wyeth would pay (and did). The suffering was real and wyeth had the only deep pocket available."
What might happen if an entire nation got a flu vaccine? By chance alone, tens of thousands of people who were vaccinated would come down with some illness after getting a flu shot and some would die. |
Dr. Timothy Scott
See book keywords and concepts |
| The resultant lawsuits will cost wyeth, the manufacturer of Redux, an estimated $21.1 billion.25 Few realize that Redux almost never made it to market. An FDA advisory committee voted 5 to 3 in September of 1995 to keep the drug off the market because animal studies found it could cause brain damage in animals. But because every drug which is approved is approved based on a risk-benefit analysis, the advisory committee reversed itself later in 1995 by a 6 to 5 vote. |
Gina Kolata
See book keywords and concepts |
| Experts testified that the company had done nothing wrong and that the baby's case of polio was probably not related to the vaccine. But wyeth lost and was ordered to pay $200,000 to the child's family. wyeth appealed to the Supreme Court, but the Court refused to hear the case and the judgment against the company held.
Neustadt and Fineberg, in their postmortem on the swine flu affair, tartly summed up what the Reyes case meant to vaccine manufacturers. The courts had ruled that wyeth had failed to adequately warn of its vaccine's dangers. |
Mike Adams
See book keywords and concepts |
 Ativan, manufactured by wyeth, while the Medi-Cal program paid $70.19, resulting in a 523 percent mark-up
<•* On August 25, 2005 California announced an amendment to a previous lawsuit and added 37 additional pharmaceutical companies to its price-fixing complaint. One drug, Atenolol in 50mg doses, was billed to Medi-Cal at $804.70—the same drug had a street price of $33.85.
<•* Bayer settled a false claims act with the federal government for $14 million in January 2001 for knowingly charging Medicaid at prices high above the costs charged to other customers. |
Jacky Law
See book keywords and concepts |
 Graham also pointed out how his research had led to the withdrawal of big drugs like Abbott's Omniflox, Pfizer's Rezulin, and Wyeth's slimming drugs Redux and Pondimin. It had taken the over-the-counter decongestant PPA off the US market, and it had contributed to the team effort that protected the public from the adverse effects of GlaxoSmithKline's Lotronex, Bayer's Baycol, and Johnson & Johnson's Propulsid.
Another indication that public trust in medicines regulation may be misplaced came when Graham returned to work, having just testified against his employers. |
| Kirk Douglas, Pierce Brosnan and Angela Bassett are all reported to take Bristol-Myers Squibb's statin, Pravachol. wyeth has used singer Patti LaBelle to promote Prempro hormone replacement therapy and engaged musical comedy stars Debbie Reynolds and Rita Moreno to urge women to have bone-density tests. Former Republican presidential candidate Bob Dole as well as Pele have both promoted Pfizer's Viagra.
The practice grows because it works. |
| By May 2004, the effects of the litigation that ensued had cost wyeth, the company responsible, $16.6 billion in damages, with one investment bank, Prudential Securities, saying another $7.5 billion might be needed to fully settle the case. |
National Women's Health Network
See book keywords and concepts |
 In public testimony, the Network opposes Wyeth's request by pointing out that every heart disease prevention drug used by men has been tested in a large randomized trial but that this has never been done for ERT/HRT.8 wyeth pays for many leading researchers to attend the meeting, and they argue that a large randomized trial of ERT/HRT isn't feasible. The FDA agrees with the Network and denies Wyeth's request.
1992 Bernadine Healy, M.D. |
Marcia Angell, M.D.
See book keywords and concepts |
 To that end, wyeth sponsors a ninety-minute forum on college campuses called "Depression in College: Real World, Real Life, Real Issues." It features doctors, psychologists, and Cara Kahn of the MTV reality show Real
World Chicago, who takes Effexor. In 2002, when the campaign was launched, wyeth told Alex Beam of The Boston Globe that four colleges had agreed to host the forum. Harvard declined. |
National Women's Health Network
See book keywords and concepts |
| In public testimony, the Network opposes Wyeth's request by pointing out that every heart disease prevention drug used by men has been tested in a large randomized trial but that this has never been done for ERT/HRT.8 wyeth pays for many leading researchers to attend the meeting, and they argue that a large randomized trial of ERT/HRT isn't feasible. The FDA agrees with the Network and denies Wyeth's request.
1992 Bernadine Healy, M.D. |
Dr. Timothy Scott
See book keywords and concepts |
| One such letter arrived linked to a meeting aimed at promoting Wyeth's SSRI Effexor. This Laguna Beach meeting came complete with honoraria, expensive travel and accommodation provision, and the opportunity to have one's article ghosted, in this case by CMED, a medical writing agency based in Toronto.6
Healy decided he could not simply attach his name to the glowing report for Effexor. He was aware of the research indicating an increase in suicide risk for those on SSRI antidepressants. He was also aware that Effexor's claim to be superior to other antidepressants was false. |
Katharine Greider
See book keywords and concepts |
| According to a recent report in
Business Week, the Premarin family came to account for 15 percent of Wyeth's sales, and as much as 30 percent of its profits. In the spring of 2002, wyeth launched a sixtieth anniversary celebration of Premarin, commissioning photographs of accomplished middle-aged women who used hormone products, to be circulated to museums, galleries, and medical meetings across the country. |
American Medical Publishing
See book keywords and concepts |
| Kassirer, editor of the New England Journal of Medicine, called Wyeth's conduct "appalling." He said:
"The whole process strikes me as egregious -- the fact that wyeth commissioned someone to write pieces that are favorable to them, the fact that they paid people to put their names on these things, the fact that people were willing to put their names on it, the fact that the journals published them without asking questions."
So here we see one of the most sorry, deceitful and sad tales in all of U.S. [prescription drug history. |
Gina Kolata
See book keywords and concepts |
| Never mind that experts had testified at trial that this particular case was not vaccine-related. wyeth would pay (and did). The suffering was real and wyeth had the only deep pocket available."
What might happen if an entire nation got a flu vaccine? By chance alone, tens of thousands of people who were vaccinated would come down with some illness after getting a flu shot and some would die. After all, tens of thousands of people get sick and many die every day. That is simply the normal course of events. |
Donald L. Barlett and James B. Steele
See book keywords and concepts |
 Lexington, Massachusetts, and marketed, once more, by wyeth.
Citing safety concerns, an FDA panel originally rejected Redux in September 1995 by a narrow vote of five to three. A highly unusual second meeting was called in November. With some of the original dissenters absent, the panel this time approved Redux by a six-to-five vote. Politics won over patient safety, and the FDA subsequently authorized sale of the new drug.
As Fortune had predicted, Wall Street greeted Redux enthusiastically. |
Email this page to a friend
