Skip to comments.Documents Suggest Merck Tried to Censor Vioxx Critics
Posted on 06/10/2005 10:43:08 PM PDT by David Lane
http://www.npr.org/templates/story/story.php?storyId=4696609 Health & Science
Part 1: Documents Suggest Merck Tried to Censor Vioxx Critics by Snigdha Prakash
All Things Considered, June 9, 2005 · Because of intense interest in this report, NPR has decided to present a full transcript.
Introduction: NPR's story about Merck and its efforts to suppress safety concerns about the painkiller Vioxx continues with a look at how Merck exerted its influence in the world of top medical institutions. NPR's Snighda Prakash presents part two of her report.
Transcript: Introduction: At least 38,000 Americans are believed to have died from taking the pain pill Vioxx before it was withdrawn last year. Drug maker Merck is now facing thousands of lawsuits.
Over the past few months, it has emerged that the company was aware for years that Vioxx might be dangerous. Now, new documents obtained by NPR suggest that even as Merck was making Vioxx into a bestseller, the company was putting pressure on independent doctors. The company's apparent aim: to keep them from discussing evidence of Vioxx's potential safety problems. The documents show that Merck exerted pressure not only on individual doctors, but also on several of the nation's top medical schools.
Merck tells NPR it did nothing wrong. NPR's Snigdha Prakash has the first story in a two-part report.
Transcript: When a drug company wants to sell a pill to a doctor, its best salesperson is usually another doctor.
Of course, drug companies don't call that selling. They call it "medical education." Or even medical research.
Well before Merck launched Vioxx, the company was targeting influential doctors who could help it build Vioxx's sales.
When they located a prospect, they entered the details about that doctor into a spreadsheet at headquarters. Spreadsheet entries included items such as:
"...treats all of the major sports teams, including the Lakers basketball team and the Dodgers baseball team, as well as the high-profile members of our society."
"... 2,4OO prescriptions per year... also known nationally... Writes for a lot of rheumatology textbooks."
Merck's vast army of sales representatives gathered intelligence on what it would take to win over individual doctors. Their notes included the following strategic observations:
"Use in many speaking engagements... At least $20,000 for speaking engagements for the remainder of the year."
"Will speak for us only at certain restaurants and high honorarium...
Likes to feel important... He needs the VIP treatment."
One of the physicians whom Merck recruited to promote Vioxx was Gurkirpal Singh of Stanford University.
Merck wanted Singh on board because he was a senior researcher on a seminal study of arthritis patients. The study showed that older painkillers, such as Naproxen, commonly caused gastrointestinal bleeding. It established the need for new painkillers, such as Vioxx and its rival, Celebrex, that were gentler on the stomach.
NPR has examined Merck documents provided by sources working with individuals and families who allege Vioxx harmed them. They're now suing Merck.
Among those documents is a memo that shows Merck started to focus on Singh in April or May of 1998 -- almost two years before Vioxx was ready for market. The overture was successful. A year later, Merck was launching Vioxx, and Singh was an important spokesman.
One document reads: "March-May 1999. Aggressively scheduled Dr. Singh for talk in preparation for launch... Reviews and feedback of Dr. Singh's presentations were generally positive." And it notes that "Dr. Singh commanded relatively large honoraria."
Merck paid Singh fees of up to $2,500 for each talk. He gave 40 talks over seven months.
Singh described the system in an interview with NPR:
"One setting which is where I was speaking predominantly was in the grand round situation in hospitals, or in medical schools, or in the universities, where like you're giving a formal lecture to the physicians," Singh said. "It's always lectures to physicians. And then the other set is usually these evening programs that drug companies arrange, where you also present your research, and then there's often a dinner with it."
Merck was pushing hard to catch up with rival drug maker Pfizer. Pfizer's new painkiller, Celebrex, had beaten Vioxx to market by a few months. It was gobbling up market share.
Then in early 2000, Merck got news of a potential problem. A large study commissioned by the company showed that patients on Vioxx suffered more heart attacks, strokes and deaths than those on the older pain pill Naproxen.
For some researchers, the results were a red flag that Vioxx might be dangerous. But according to the company, the new evidence was outweighed by many previous studies that showed the drug was safe.
Merck scientists interpreted the study in a postive way. In a series of press releases, Merck said the study showed that the older drug protected against heart attacks -- not that Vioxx caused them. The company confirmed that Vioxx was safe for the heart.
Merck gave the study data to the Food and Drug Administration, and the two began a protracted debate over what the study meant, and what to tell doctors and patients about it.
Meanwhile, despite the positive spin of Merck's press releases, Singh was uneasy about the new study.
"I was worried, because obviously this was something new," Singh said. "This was something we had never seen before."
As an independent scientific expert, Gurkirpal Singh wanted to evaluate the study for himself.
Singh asked Merck repeatedly for the data. "I wanted to know how many heart attacks, how many strokes, how many deaths were occurring in each one of the groups, and what were these actual number of patients at risk, and how many ended up having an event," he said.
Singh says for months, Merck's scientific education department assured him that the results would be available soon -- at one scientific meeting, then another. They never were.
Singh got tired of waiting. He shared his concerns with at least one prominent European scientist, and he began to allude to his concerns in talks.
Inside Merck, Susan Baumgartner, a Vioxx marketing manager, wrote this e-mail:
"June 19, 2000: Dr. Singh continues to play up the cardiovascular adverse events associated with Vioxx... I think there are many other speakers who deliver good messages, and we should not risk supporting the negative messages that he continues to deliver."
The Merck sales machine, which included the departments of marketing, scientific education and physician outreach, had begun to show its other face. It had paid Singh fat speaking fees. Now it was canceling many of his educational lectures.
The documents obtained by NPR show that for much of June 2000, Merck executives conferred on how to rein in their skeptical consultant. At least 23 local, regional and national executives took part in the discussions. They feared that just as Singh's credibility had opened doors for Merck, it could close them.
Singh was widely respected at the FDA. He also had connections with large institutional buyers that were vital to Vioxx's sales.
Terry Strombom, who was senior business director for the San Francisco region, sent an e-mail on June 5, 2000, that shows Merck was walking a tight rope -- it wanted to censor Singh, but was afraid of alienating him. The e-mail read:
"The one thing I am pretty sure of is that Dr. Singh could impact us negatively if he chose to do so... I would recommend we handle this very carefully... I just don't think canceling all the programs and walking away completely will serve us well in the long term."
The e-mails show that at the same time that Merck was trying to censor Singh, at least one Merck official acknowledged that Singh's concerns about Vioxx were legitimate.
Heather Robertson, the coordinator of health education liaisons for the San Francisco region, reported on a conversation with Singh's main scientific contact at Merck, who has since left the company. Her e-mail of June 5, 2000, read:
"I spoke to Kirsten directly for the first time this past week to learn that Dr. Singh makes a balanced presentation (he must since he is an FDA advisor) but reports product information that is not favorable to Merck... Kirsten feels that no amount of work would change Dr. Singh's position, and although we may not like to hear about it, his information is scientifically accurate."
Later, Merck would advise its sales representatives not to discuss Vioxx's risks to the heart, and to have doctors send their questions to headquarters.
We showed the Merck documents to David Rothman, director of the Center on Medicine as a Profession at the Columbia University College of Physicians and Surgeons. He says the Merck documents consistently show a disregard for the substance of the scientific arguments about Vioxx.
"The drug companies will use the language of objective neutral science," Rothman says. "But what speaks much louder is 'You're for us, or you're again' us. And if you're again' us, we're going to try to get you.'"
Merck's surveillance system had many ways to pick up who was for them or against them. Physicians, including advocates with financial ties to Merck, contacted the company when they heard criticism.
A document from July 21, 2000, reads: "Communication from advocate regarding a program given by Dr. Singh... It was hyper-inflammatory."
Singh's allegiance was shifting. He was now promoting Vioxx's rival, Celebrex. He was being paid by Pfizer, and he was telling his audiences that Merck had refused to answer his questions about Vioxx's safety. A July 2000 document notes: "Received reports that Dr. Singh showed a cartoon of a character hiding under a blanket and asked the audience to speculate about what it is that Merck is trying to hide."
Merck's sales force was also keeping tabs on the buzz in doctors' offices. As sales representatives gave out free Vioxx samples, they asked doctors if they'd heard anything new about Vioxx. The sales reps would transmit this intelligence via voicemail to the company's National Service Center. Another Merck document, from July 26, 2000, notes:
"NSC report that at nine meetings in the L.A. area over the last three days, Singh presented sessions that were very unfavorable to Vioxx."
A week later, Singh would convey his concerns to one of the country's largest and most influential drug purchasers, the Department of Veterans Affairs. The VA started asking Merck if Vioxx was safe for the heart. The company's most senior scientists were brought in to answer the VA's questions. It was clearer than ever that Singh had become a major liability for the company.
Dealing with Singh was now a job for Merck's senior vice president for medical and scientific affairs -- Dr. Louis Sherwood. Sherwood was a former academic and had been chief of medicine at a top medical school.
Merck documents obtained by NPR show that a detailed account of Singh's activities was now prepared for Sherwood. Almost a dozen Merck executives were involved. A senior regional executive who had supervised Singh's scientific handlers sent this Oct. 4, 2000, e-mail:
"I have in excess of 80 e-mails pertaining to interactions with Dr. Singh from March 1999 to present. The following is my best recollection of what has happened. Because of the sensitive nature of the following, I strongly encourage you not to share with anyone unless they clearly have a need to know."
The profile of Dr. Singh is remarkably complete," says Columbia's David Rothman, who reviewed the final document for NPR. "One can't help but almost frame it in terms of an FBI dossier, except here Dr. Singh is not cavorting with possible communists, or possible gangsters. Here the dossier is filled with Dr. Singh's take on Vioxx, who is Dr. Singh talking to. It's scrupulously watched and very, very carefully recorded."
The profile was dispatched to Sherwood and six other executives. Around the same time, Singh heard from a friend inside Merck: "I was told that Dr. Lou Sherwood, who was then vice president at Merck, had become 'very interested,' in quotes, in what I was doing, and that Dr. Sherwood is "very powerful, and he's going to crush you and he's going to fix you.'"
Dr. Louis Sherwood's campaign to "fix" Vioxx critic Gurkirpal Singh began with a series of phone calls to Singh's bosses at Stanford University.
"I don't usually receive phone calls on a Saturday at home from representatives of drug companies," says James Fries, a professor of medicine at Stanford. "So it was definitely unusual."
The call came on Oct. 28, 2000. " I received a call from a medical director at Merck, stating that someone on my staff had been making wild and irresponsible public statements about the cardiovascular side effects of Vioxx," Fries says. He says Sherwood hinted there would be repercussions for Fries and Stanford if Singh's statements didn't stop. He was left with the sense that Merck's financial support to Stanford was at risk.
Fries started making calls of his own and learned that researchers at seven other institutions, including the University of Minnesota, the University of Texas Southwestern and a Harvard teaching hospital, had also raised doubts about Vioxx's safety. Sherwood had placed calls to those institutions as well.
"A number of investigators who had spoken publicly had been called or the chairs of their departments had been called, "Fries says. "The deans of their medical schools, and a variety of veiled and not so veiled threats had been made -- that they were saying bad things about the drug company, and that the people to whom they reported should take steps to see that this stopped."
At Merck, Medical Director Sherwood wrote an e-mail to bring the marketing department up to speed. NPR has obtained that e-mail. It suggests that part of Merck's strategy to suppress criticism was intimidation. The e-mail, dated Nov. 7, 2000, reads:
"Fries and I discussed getting Singh to stop making the outrageous comments he has in the past few months... I will keep the pressure on and get others at Stanford to help."
Sherwood advises one of the marketing executives how to pressure Singh himself. He says: "Tell Singh that we've told his boss about his Merck-bashing." And tell him, " should it continue, further actions will be necessary (don't define it.) "
Lisa Bero is a professor of clinical pharmacy and health policy at the University of California, San Francisco. She's done extensive research showing how funding from drug companies influences academic science. She reviewed Sherwood's email at NPR's request.
"I didn't realize how powerful the drug companies thought they were," Bero said. "For example, having enough influence over a department to say 'change what your faculty member is saying.' I haven't ever seen that documented before."
Another document written by Sherwood shows Merck tried to use that influence on several occasions. After Stanford Professor James Fries learned about Sherwood's calls to other medical institutions, he sent a strongly worded letter to Merck's CEO. The letter questioned the propriety of Sherwood's calls. Sherwood wrote an internal memo in response. NPR has obtained that memo.
In it, Sherwood writes there was no "orchestrated campaign or specific program" to deal with what he calls '"problem individuals." Yet, he lists groups of Merck executives who managed those critics. The memo, dated Jan. 23, 2001, reads in part:
"I will only get involved when our representatives... regional medical directors, Merck research lab physicians... or key individuals in the therapeutic business group have felt frustrated by their inability to reach out or to 'balance' selected individuals."
And Sherwood implies that when that happened, he did lean on Vioxx critics -- and on their institutions: "Without trying to appear immodest, I believe I am the most respected physician in the pharmaceutical industry among academic chairs and deans... Therefore, when I call them on a matter of urgent concern, they generally take it seriously... This has been a source of strength ... as I have been able to exert balanced leverage in some difficult situations."
UCSF's Bero says, "Well, the first thing I thought is, 'What kind of leverage are we talking about?' And the first thing I thought of was money, in all the various ways that it can come to departments."
In 2004, Stanford's medical school got 9 percent of its research budget -- $29 million -- from drug companies. NPR surveyed several medical schools and found that's not unusual.
David Rothman is at the Columbia University College of Physicians and Surgeons.
"Look, medical research is expensive," says David Rothman of the Columbia University College of Physicians and Surgeons. "No one can take a call from a drug company high official, critical of an investigator, and not realize that behind that call is the implicit reminder, implicit threat -- 'If you can't control your folks, how do you expect us to continue to do business with you?''"
Merck and Sherwood deny the allegations in this story. Ted Mayer, a lawyer representing Merck, says, "Merck was not trying to silence critics. The scientific or the safety profile of this product was very well known in data that was available to the public, and it was vigorously debated in the public, and it's perfectly appropriate to have that vigorous debate."
Mayer says Merck was concerned about Dr. Singh because many of his talks went far beyond that vigorous debate: "The number of people who heard those talks and who were physicians and understood the data well believed that those talks contained unbalanced and inaccurate information, and that the views weren't supported by the data and were kind of at the extreme end among hundreds of scientists who were making these kinds of presentations."
In an interview with NPR, Dr. Louis Sherwood says it was rare for him to complain to department heads. He says he firmly believes in academic freedom. He says he only made calls when faculty members were being unfair to Merck and acting unprofessionally.
"I never, never made any threats to withdraw funding or hamper anyone's faculty appointment," Sherwood said. "Under no circumstances did I ever do that."
Then why did Stanford's James Fries feel threatened when Sherwood called?
"No one likes to be criticized," Sherwood said. "Now sometimes, when an academic physician is criticized for his or her actions, they may interpret that as a threat. But under no circumstances did I threaten Stanford or Dr. Fries or anyone with funding issues or anything else. That would've been inappropriate."
FDA whistleblower Doctor David Graham estimates that at least 38,000 people died from taking Vioxx. Drummond Rennie, deputy editor of the Journal of the American Medical Association, notes that "each one of those is somebody, is a real person, with a real family, real people who grieve for them."
"I think it's the job of a physician, physicians who're doing research, physicians who work in drug companies -- all physicians -- to care about that," Rennie said.
Merck says its physicians strongly believed in the safety and benefits of Vioxx. The company says the risks of Vioxx weren't clear until just last fall, when, it says, Merck acted promptly and voluntarily withdrew Vioxx.
** Sidebar: Med Schools & Drug Firm Funds
An informal survey of medical schools by NPR found that some schools rely on funding from pharmaceutical and other health-industry sources.
The issue is taking on increasing importance. Government funding for medical research is not expected to increase in coming years and could decline. Medical schools will be more reliant on private, for-profit industry for funding. That raises concerns about academic freedom and restrictions on what researchers can and cannot say in print and in public
'MEDS' not 'HIV' - The real killer Don't believe what the drugs companies tell you.
WITHOUT HAART 'MEDS"
These long-term nonprogressors [Hiv+ people who remained healthy] are a heterogeneous group with respect to viral load and HIV-1 responses none had been treated with antiretroviral agents.
AIDS Research and Human Retroviruses, 12: 585 (1996) Harrer, Thomas, et al, Aids Researchers
NOT ONE USED HAART
Subjects: homosexual men in Amsterdam. None of the LTAs [long-term asymptomaticspeople who remained healthy] received any antiviral drugs during the study [7 years].
Ten HIV+ people; 11-15 years infected; non-progressors [i.e., healthy]; maintained stable T-cell counts above 500. These long-term nonprogressors all showed the same risk factor (sexual exposure), and all had...virus...and none had been treated with antiretroviral agents.
AIDS Research and Human Retroviruses, 12: 585 (1996) Harrer, Thomas, et al, Aids Researchers Journal of Infectious Diseases, 171:811 (1995) Hogervorst E, et al, Aids Researchers _________ __________
Choosing between many of these [HAART] combinations is, therefore, increasingly dependent upon knowledge of antiretroviral toxicities...[which include] myopathy [gross muscle atrophy] (zidovudine [AZT]), neuropathy (stavudine, didanosine, zalcitabine; hepatic steatosis and lactic acidaemia (didanosine, stavudine, zidovudine); and possible also peripheral lipoatrophy and pancreatitis (didanosine)...drug hypersensitivity... lipodystrophy...[including] peripheral fat loss (Presumed lipoatrophy in the face, limbs and buttocks) and central fat accumulation (within the abdomen, breasts and over the dorsocervical spine [so-called buffalo hump]...[and prevalent in] about 50% [of patients] after 12-18 months of therapy...Metabolic features significantly associated with lipodystrophy and protease-inhibitor therapy include hypertriglyceridaemia, hypercholesterolaemia, insulin resistance...and type 2 ...diabetes mellitus. Dyslipidaemia at concentrations associated with increased cardiovascular disease occurs in about 70% of patients. These metabolic abnormalities are more profound in those receiving protease inhibitors...Most cases of diabetes have been identified in recipients of protease inhibitors...Anemia and granulocytopenia affect about 5-10% of patients who receive zidovudine...Virtually all antiretroviral medications can cause nausea, vomiting, or diarrhoea early in therapy...Diarrhea is probably most common with protease inhibitors...Most antiretroviral agents have been associated with hepatic [liver] toxicity...Most protease inhibitors seem to result in increased rates of spontaneous bleeding (bruising, haemarthrosis, and rarely intracranial haemorrhage) in haemophiliacs... 25-35% of patients cannot tolerate [AZT monotherapy] or triple combination therapy for 4 weeks...
Lancet. 2000 Oct 21;356:1423-0. Carr A, Cooper DA, Aids Researchers
This study was conducted to determine the likelihood of the development of [immune recovery vitritis, IRV], which causes vision loss in AIDS patients with cytomegalovirus (CMV) retinitis, who respond to HAART. We followed 30 HAART-responders Symptomatic IRV developed in 19 (63%) of 30 patients.
J Infect Dis. 1999 Mar;179(3):697-700
Recently, we observed an unusual cluster of cases of rapidly progressing multicentric Castlemans disease. Fever, weakness, generalized enlargement of lymph nodes, and marked polyclonal gammopathy developed in three patients with AIDS...Two of these patients died within one week after the diagnosis, with generalized involvement of the lymphatic system, liver, and bone marrow at autopsy. A fourth patient with AIDS who died equally rapidly after the diagnosis of multicentric Castlemans disease had been seen in our hospital 14 months earlier... symptoms started after the initiation of highly active antiretroviral therapy in these three patients.
N Engl J Med. 1999 Jun 17;340(24):1923-4 Zietz C, et al, Aids Researchers Karavellas MP, et al, Aids Researchers
DEATH Of the 70 patients studied, 84% were still alive after the 3-month study period...17 surviving patients (24%) had HAART regimens discontinued due to drug intolerance and 11 (16%) expired [died] during the study period... J Pain Symptom Manage. 2001 Jan;21(1):41-51
The antiretroviral drugs currently licensed in the United Kingdom [June 1996] are zidovudine (azidothymidine [AZT]), zalcitabine (ddC) and didanosine (ddI). All three are nucleoside analogues...All are very toxic. Suppression of bone marrow elements can occur with any of the three, as can peripheral neuropathy [nerve damage].
Adverse Drug Reaction Bulletin. 1996 Jun;178:675-8. Ellis C.J., Leung D., Aids researchers
A decrease in mtDNA [DNA of the mitochondria; the energy regulating entities within every cell] content was found in HAART-treated HIV-infected patients with peripheral fat wasting in comparison with subjects in the control cohorts...Lipodystrophy with peripheral fat wasting following treatment with NRTI [Nucleoside Reverse Transcriptase Inhibitor]-containing HAART is associated with a decrease in subcutaneous adipose [under the skin fat] tissue.
AIDS. 2001;15:1801-9 Shikuma CM, Hu N, Milne C, et al, Aids Researchers
These drugs are as dangerous as chemotherapy, 7 HIV patients presenting LD [Lipodystrophy, all taking antiretroviral therapy] and 5 HIV non-LD controls participated in the study Structural muscle abnormalities, mitochondrial respiratory chain dysfunction or mtDNA deletions were detected in all HIV lipodystrophic patients. The mitochondrial abnormalities found suggest that mitochondrial dysfunction could play a role in the development of antiretroviral therapy-related lipodystrophy. AIDS. 2001 Sep 7;15(13):1643-51 Zaera MG, et al, Aids Researchers
Combination drug therapy, or the triple-drug cocktail often provokes severe side effects These drugs are as dangerous as chemotherapy, warned Dr. James Kahn, UCSF associate professor of medicine Science Daily, Sep 4, 2001
SEXUAL DIFFICULTIES - Body distortions
[Chapters in this guide to HIV drugs are entitled Introduction, Appetite loss, Body distortions (lipodystrophy), Bone death and destruction, Cardiac concerns, Diarrhea, Fatigue, Gas and bloating, Hair loss, Headaches, Insulin resistance and diabetes, Kidney stones, Liver toxicity, Muscle aches and pains, Nausea and vomiting, Nightmares, daymares and sleeping difficulties, Pancreatitis, Peripheral neuropathy, Skin problems, Sexual difficulties, The end]
A Practical Guide to HIV Drug Side Effects, CATIE, 2002
HEART ATTACKS Use of protease inhibitors was strongly associated with the likelihood of having a myocardial infarction [heart attack] and correlated with diabetes mellitus and hyperlipidaemia. Lancet. 2002 Nov 30;360(9347) Holmberg SD, et al, Aids Researchers
This article was almost certainly written by an author who received all his information from trial lawyers who are attempting to try their case in the media. All the "experts" cited have almost certainly been hired by the trial lawyers to assist them in their case.
This article needs to be taken with a grain of salt.
"hired by the trial lawyers"
We all know the drugs companies don't employ teams of high priced lawyers.
The ethical drugs companies would never stoop so low as to use public relations firms or high priced lawyers to hide their crimes.....they care little for profit but only care about the public good.
So glad you drew attention to that 'fact'.
Instead of the government giving money to various researchers and drug companies for "research" and worthless clinical trials (of which there are many), they should just announce that they are STOPPING IT.
Further, they should announce that all such monies will be deposited into interest-bearing accounts (one for each currently funded disease). The first person to come up with a "cure" for the disease takes ALL OF THE MONEY. If they come up with a definitive, exceptionally life-extending treatment, they might qualify for a pro-rated portion. Hopefully, some of the private funds would follow suit.
Doesn't matter if it's a guy in his home lab; a student at a University; or the traditional "research lab" at a pharma company. Everyone in the world would be eligible.
That, of course, will never happen. WAY to many campaign funds to lose. We need to pay people for results; it eliminates the tendency to keep the funding coming at the expense of the patients. It certainly would put some focus into their research.
"We need to pay people for results"
Great post. At the moment we seem to be paying for results.....the wrong results.
Every day more and more evidence comes to light that many drugs are doing far more harm than good. The CDC admits that 48.2% of so called AIDS' deaths are from HAART 'side effects' but then happily calls them 'AIDS mortalities' and uses tax payers money to buy even more of these deadly drugs.
A cycle of madness and profit.
I think you have read too much into my comment.
What I said was true. This is a one-sided article.
That doesn't mean that it is wrong.
But I think that a person trying to objectively consider the merits of this controversy should attend to the fact that it is only one side of the story.
I gather, however, that your mind is already made up.
Sorry if I over reacted but I have studied drugs company practices for years now and believe me, this is only the tip of the iceberg.
Glaxco has been convicted again and again for actions that have resulted in many death (that they knew would result) and they simply pay the fines and change nothing.
The fines are usually a few million but the profits can run hundreds of times higher.
Like illigal drugs dealers they simply consider the fines part of the cost of doing business and the deaths as a minor PR problem.
There Is No Doubt That Glaxo Is A Problem !
UK Observer July 8, 2001
Drug Company Admits Unsafe Vaccines Were Used
The former UK company Wellcome allowed thousands of babies to be inoculated in the 1960s and 1970s with toxic whooping cough vaccines it knew had not passed crucial safety tests, the Observer, a UK newspaper, claimed on July 8.
It said its investigations showed that two batches of the firm's vaccine were more than 14 times more potent than the standard dose and 14 other batches containing thousands of vaccine doses were not put through a crucial toxicity test.
One of the toxic batches was the same batch that led the Irish Supreme Court in 1992 to award £2.7 million (US$3.8 million) in compensation to Kenneth Best, a Cork boy who suffered permanent brain damage. At the time the Irish judge accused Wellcome of negligence and attacked the company's poor quality control at its Kent laboratory.
Now, 9 years after the award, the newspaper said the Irish Department of Health had received details from GlaxoSmithKline about the batch--numbered 3741--and was tracing 296 Irish children who were inoculated with it.
Glaxo Wellcome merged with SmithKline Beecham to form GlaxoSmithKline in late 2000.
The newspaper added that pressure from Denis Naughten, a senior Irish Member of Parliament (MP), has forced other disclosures from the company, including the fact that a second batch of vaccine, numbered 3732, produced by Wellcome around the same time, was even more potent than that used on Best in 1968.
In the 3 years after Wellcome produced the toxic batches, dozens of British parents believed their children suffered brain damage or even died as a result of the whooping cough vaccine. But their views were dismissed by drug companies and health officials.
The report quotes Gordon Stewart, emeritus professor of public health at Glasgow University, as saying the revelations are "scandalous." Stewart, who in 1984 was asked by the government's Chief Scientific Officer to investigate a link between brain damage and the vaccine, said he advised the Department of Health about these potential toxic batches in 1989 but they did not act.
His report, which was never published by the government but has been seen by The Observer, is highly critical of the whooping cough vaccine used at this time, which he believes was toxic.
Ian Stewart, Labor MP and chair of the all-party Commons committee on the vaccine issue, said he would be holding an emergency meeting of the committee this week and tabling a series of parliamentary questions.
He said, "The families need to know the truth."
"If it can be shown that Glaxo Wellcome were negligent in allowing toxic vaccines to be used, then the company must face up to its responsibilities."
The families of vaccine-injured children receive £100,000 compensation from a government fund financed by the taxpayer. Stewart believes if the firm is at fault, then they should pay compensation, which would be significantly more.
Source: http://www.vaccinationnews.com Vaccination News
Vioxx - best medicine ever invented. Cured my arthritis nearly instantaneously. A miracle drug.
Glaxo Faces Criminal
Action In UK Over
'Suicide' Pills - Paxil
From Dr. Ann Blake Tracy, PhD
This is a newsletter that just went out to our Drugawareness E-group and I knew you would all be interested in this late breaking news on the antidepressant front as well.
Also, if any of you carried the story last Wednesday on Prozac being good for children you should know that both Dr. Emslie and Dr. March have major confilcts of interest and therefore, never should have been allowed to do this study.
On top of that, in reading the results of the study there was NO evidence that Prozac was beneficial unless you call what they found as beneficial: a DOUBLING of the suicide rate and a suicide attempt rate FIVE TIMES GREATER on Prozac than placebo. So, I ask again, where was the evidence of any benefit? And why was none of that reported to the public?
IDS Research Chief Rewrote Safety Report
Tue Dec 14, 6:58 PM ET
Health - AP
By JOHN SOLOMON, Associated Press Writer
WASHINGTON - The government's chief of AIDS (news - web sites) research rewrote a safety report on a U.S.-funded drug study to change its conclusions and delete negative information. Later, he ordered the research resumed over the objections of his staff, documents show.
As of November 10, 2000, FDA had received and reviewed a total of 70 cases of serious post-marketing adverse events, including 49 cases of ischemic colitis and 21 cases of severe constipation.
Of the 70 cases, 34 resulted in hospitalization without surgery, 10 resulted in surgical procedures, and three resulted in death. FDA has received two additional reports of death that the agency did not classify as being cases of ischemic colitis or severe complications of constipation.
FDA has been closely monitoring the drug since approval on February 9, 2000. Prior to approval, four cases of ischemic colitis were observed in clinical studies and were discussed at a November 1999 meeting of FDA's
Gastrointestinal Drugs Advisory Committee. These cases were transient, mild-to-moderate in nature and reversible upon discontinuation of the drug.
Between approval and June 1, 2000, FDA received seven post-marketing reports of serious complications of constipation. This resulted in the hospitalization of six patients, three of whom required surgery. During the same time period, FDA received eight post-marketing reports of ischemic colitis. This resulted in four hospitalizations, four endoscopic procedures, and no surgeries.
On June 27, 2000, FDA convened a public advisory committee meeting where risk management options in response to the serious adverse event reports were discussed. No deaths were reported up to that date. The consensus of the advisory committee members was that both physicians and patients must be informed of the potentially serious adverse events associated with Lotronex.
Following the meeting, FDA updated the healthcare professional labeling for Lotronex and required the drug?s sponsor, Glaxo Wellcome, to distribute a Medication Guide that warned patients directly about the risks associated with the drug. In addition, at the request of FDA, Glaxo Wellcome issued "Dear Healthcare Professional" and "Dear Pharmacist" letters to advise these groups of the important new information.
FDA continued to receive severe adverse event reports of ischemic colitis and complications of constipation associated with Lotronex. In addition, FDA received reports of death and more serious complications of ischemic colitis that required blood transfusion or surgery.
Upon completing its recent analyses of the 70 cases, FDA's view of the options included marketing withdrawal or a restricted drug distribution program. The restricted drug distribution program would provide: (1) safe use of Lotronex in appropriately informed patients, (2) continued access to Lotronex by severely debilitated IBS patients under closely monitored conditions, and (3) continued clinical research into the benefits, risks, and safe and appropriate use of Lotronex. FDA recognized that the other available treatments for IBS may offer inadequate relief from a condition that can be severely incapacitating for some patients.
At the conclusion of today's meeting, Glaxo Wellcome informed FDA that it will voluntarily withdraw Lotronex from the market.
For more information on this subject, visit the Lotronex Information web page created by FDA's Center for Drug Evaluation and Research. The URL is
Some poor guy discovered that most ulcers are caused by a bacteria. Proved it, was screaming it from the rooftops, and was completely ignored.
He thought "outside of the box" (I really hate that term, but it is applicable).
The medical establishment, kicking and screaming the entire time, finally had to acknowledge him.
Who knows? Cancer might be caused by a bacteria, fungus, or virus and easily treated while the indoctrinated concentrate on variations of chemo and other lethal treatments. They tend to look at the minutiae of cellular biology, thinking it's the cause and not the effect.
FWIW, I'm in no way an alternative therapy type; I just think they've turned their heads in the wrong direction.
Pay them to figure it out; and they will. They ALWAYS DO.
Material from the Independent is not allowed.
Sorry. I will never post any in future.
."Once upon a time, drug companies promoted drugs to treat diseases," Dr. Angell writes. "Now it is often the opposite. "
Indicting the Drug Industry's Practices
By JANET MASLIN
Dr. Marcia Angell is a former editor in chief of The New England Journal of Medicine and spent two decades on the staff of that publication. If much of that time was devoted to reviewing papers on pharmacological
research, it must have been spent in a state of near-apoplexy.
Her new book is a scorching indictment of drug companies and their research and business practices. "Despite all its excesses, this is an important industry that should be saved - mainly from itself," she writes.
This turns out to be one of her book's more forgiving pronouncements, since the rest of it is devoted to assertions of shady, misleading corporate behavior. If she is accurate in her assumptions about big drug
companies' feistiness and tenacity, Dr. Angell is likely to be on the receiving end of angry rebuttals. She is sometimes vague enough to leave room for such attacks. ("I have heard that morale in some parts of the
F.D.A. is extremely low, and I can certainly understand why it might be.")
."Once upon a time, drug companies promoted drugs to treat diseases," Dr. Angell writes. "Now it is often the opposite.
Please provide source names and working links for all of these articles in your posts, 11, 13 and 14. Thanks.
Provide a source and link for all excerpted published material you post. Also stop loading the sidebar topics.
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