Few articles on my favorite subject: FDA and drug conspiracy :) But this time, we see some tries of FDA to get back USA in the game of the big. Which is good. But also, seeing for first time, so many failure of the pharmacy giants to comply some of the rules makes me wonder how many regulations actually they aren't complying and how many lives are being risked. Also notice how FDA is not unofficially blaming Chine for the poisoning of the heparin. Hmmm. Is it washing its hands? Because if China's government is involved in something like this, we have very big problem. Especially if we realise what part of the things we used is produced in China and how easy is for China to abuse its power.
- F.D.A. Warns Merck About Plant
- Heparin Contamination May Have Been Deliberate, F.D.A. Says
- Drug From Genentech and Biogen Fails as a Lupus Treatment
- Merck Cholesterol Drug Rejected by F.D.A.
By the way, another something I learned today is that there is an ongoing battle between giants and generic producers over patents in USA. The idea was that if a company lies in order to obtain a patent (meaning it provides falsified data, for example), its patent should be removed. Which is very bad for giants, as they live on the patent so to say, and anyway, they lie quite often in their applications for patents. And thanks to that, it seems officials are lining their way. Which is very bad for the dear patient. Because the pharmacy giants are going to just get away with their frauds and deceptions. F.D.A. Warns Merck About Plant
By THE ASSOCIATED PRESS
Published: May 1, 2008
The Food and Drug Administration has ordered Merck & Company to correct numerous manufacturing deficiencies at its main vaccine plant, the agency said Wednesday.
The agency released a warning letter sent to Merck’s chief executive, Richard T. Clark, that states its inspectors had determined that manufacturing rules were not being followed at the plant in West Point, Pa., just outside Philadelphia.
The plant, which recalled two vaccines in December over sterility problems, makes a number of children’s vaccines and four for adults.
The nine-page letter states that the agency found “significant objectionable conditions” in the manufacture of vaccines and drug ingredients during repeated inspections from Nov. 26 to Jan. 17.
In a separate posting on its Web site, the agency said it had issued the warning letter because Merck’s response to the F.D.A. report sent after the inspections was “inadequate to address the serious deviations noted.”
Amy Rose, a spokeswoman for Merck, said, “We’re committed to working with the F.D.A. to ensure that all these issues are addressed to their full satisfaction.” source
Heparin Contamination May Have Been Deliberate, F.D.A. Says
Published: April 30, 2008
WASHINGTON — Federal drug regulators believe that a contaminant detected in a crucial blood thinner that has caused 81 deaths was added deliberately, something the Food and Drug Administration has only hinted at previously.
“F.D.A.’s working hypothesis is that this was intentional contamination, but this is not yet proven,” Dr. Janet Woodcock, director of the Food and Drug Administration’s drug center, told the House Subcommittee on Oversight and Investigations in written testimony given Tuesday.
A third of the material in some batches of the thinner heparin were contaminants, “and it does strain one’s credulity to suggest that might have been done accidentally,” Dr. Woodcock said.
Two weeks ago, Food and Drug Commissioner Andrew C. von Eschenbach told a Senate subcommittee that the contamination was done “by virtue of economic fraud,” but he quickly withdrew the remark, saying he had “probably gone too far.”
Dr. Woodcock’s statement on Tuesday was part of growing chorus that has labeled the heparin contamination as perhaps the most brazen poisoning episode since 1982, when seven people in the Chicago area died after taking Tylenol that had been laced with cyanide.
The Tylenol case led to substantial changes in product packaging, and the heparin contamination has led both Democratic and Republican committee members to call for major changes in the way the F.D.A. functions and is financed.
David G. Strunce, chief executive of Scientific Protein Laboratories, the company that supplied contaminated heparin material to Baxter International, which manufactured and distributed the finished drug, described the contamination as “an insidious act” that “seems to us an intentional act upstream in the supply chain.”
The F.D.A. has identified Changzhou SPL, a Chinese subsidiary of Scientific Protein Laboratories, as the source of the contaminated heparin. A Congressional investigator said the contaminant, oversulfated chondroitin sulfate, cost $9 a pound compared with $900 a pound for heparin.
Mr. Strunce said that his company tried to find the original source of the contamination but was stopped by the Chinese authorities.
Chinese officials have disputed the F.D.A. contention that the contaminant caused death and injury, and they have insisted on the right to inspect American drug plants if the F.D.A. insists on inspecting Chinese ones.
David Nelson, a Congressional investigator, told the House panel that had the F.D.A. inspected the Chinese plant, the contamination could have been averted.
F.D.A. officials have admitted that they mistakenly failed to conduct an inspection of the Changzhou SPL plant but said that an inspection would not have been able to uncover the contamination.
The agency finally conducted an inspection of the facility in February and found so many problems that the F.D.A. blocked the plant from exporting to the United States. Mr. Nelson was even more critical of Baxter International, which bought heparin ingredients from Changzhou SPL from 2004 through 2008 but did not inspect the facility until September 2007.
Under withering questioning, Dr. Woodcock said that the F.D.A. would need another $225 million annually to inspect every foreign drug plant every other year, the frequency most say is needed. The agency will spend $11 million this year on foreign drug inspections.
There is a growing bipartisan consensus on Capitol Hill that the F.D.A. needs a rapid increase in its budget to ensure the safety of the nation’s drugs, medical devices and food.
The Bush Administration has proposed increasing the agency’s budget next year by only 3 percent to $1.8 billion, not enough to cover even its expected cost increases. source
Drug From Genentech and Biogen Fails as a Lupus Treatment
April 30, 2008
The biotechnology giants Genentech and Biogen Idec on Tuesday became the latest companies to fail at treating the immune system disease lupus.
The companies said that their drug Rituxan did not achieve any of seven measures of effectiveness in a late-stage patient trial. Rituxan is already approved to treat non-Hodgkin’s lymphoma and rheumatoid arthritis and had sales last year of $2.3 billion in the United States alone.
The lupus setback was announced only two weeks after the companies said that Rituxan had not worked against a severe form of multiple sclerosis. While analysts had generally not expected success in the multiple sclerosis study, expectations were somewhat higher for the lupus trial, despite failures by other companies.
The “complete failure” of Rituxan in the lupus trial “is somewhat of a surprise to us and creates an even more challenging year” for Genentech’s stock, William Tanner, an analyst with Leerink Swann, wrote in a note to clients Tuesday.
Genentech lost more than $5 billion in market value Tuesday, with its stock dropping $5.23, or 7 percent, to $67.93. Biogen shares, which tend to trade more on prospects for its multiple sclerosis drug Tysabri, fell $3.34, or 5 percent, to $61.33.
The news is also a blow to patients with lupus, a disease in which the body’s immune system can attack many of the body’s own organs. No new drugs have been approved to treat lupus in more than three decades, and other companies — including La Jolla Pharmaceutical, Aspreva Pharmaceuticals and Genelabs Technologies — have also had setbacks.
Dr. Merrill said proving that a drug works was difficult because there is great variation in symptoms among patients with lupus, and there are few objective measures of severity of the disease. Dr. Merrill is a consultant to Genentech and was an investigator in the Rituxan trial.
An estimated 250,000 to 500,000 Americans, most of them young women, have systemic lupus erythematosus, the severe form of the disease against which Rituxan was tested. More than 1.5 million Americans have some form of lupus, according to the Lupus Foundation of America.
The late-stage clinical trial involved 257 patients, who received either Rituxan or a placebo, along with a steroid to damp the immune system. The main indicator of success was to be how many patients had responded to treatment, as measured by an index of disease activity. Rituxan was not superior to the placebo on this measure or on any of six secondary measures, the companies said.
Genentech and Biogen are continuing a separate late-stage clinical trial testing Rituxan as a treatment for lupus nephritis, an inflammation of the kidneys. Results are expected in the first quarter of 2009.
Rituxan works by depleting B cells — blood cells involved in forming antibodies, proteins that attack invading pathogens. The main use of the drug is against non-Hodgkin’s lymphoma, a cancer of B cells. But there is emerging evidence that antibodies and B cells are involved in diseases like lupus, multiple sclerosis and rheumatoid arthritis, in which the immune system attacks the body’s own tissue.source
Merck Cholesterol Drug Rejected by F.D.A.
By THE ASSOCIATED PRESS
Published: April 29, 2008
An experimental cholesterol drug being developed by Merck & Company was rejected by the Food and Drug Administration, the company said on Monday.
Merck said the agency issued a “not approvable” letter, stating that it needed more information on the drug, Cordaptive, a cholesterol treatment that Merck had long promoted as a crucial addition to its lucrative cholesterol franchise, which has been under fire this year.
The cholesterol drug, also known as MK-0524A, can both lower LDL, or bad cholesterol, and raise HDL, or good cholesterol, Merck says.
“We plan to meet with the F.D.A. and to submit additional information to enable the agency to further evaluate” the drug’s risks and benefits, Peter S. Kim, president of Merck Research Laboratories, said in a statement. Merck disclosed the agency’s action after the close of market trading, and its stock fell 5 percent, to $39.35 a share, in after-hours trading on Monday.
Merck’s former cholesterol blockbuster, Zocor, lost billions in annual sales after it faced generic competition in 2006. The company, and a partner, the Schering-Plough Corporation of Kenilworth, N.J., jointly sell two other cholesterol drugs, Zetia and Vytorin, which combines Zetia and Zocor.
The drug makers have been accused of trying to protect sales by delaying results of a study that showed Vytorin worked no better than Zocor, which is much cheaper; the companies deny the accusation.
Cordaptive combines an extended-release form of the B vitamin niacin with a chemical to inhibit a niacin side effect called flushing — redness, burning and tingling of the face.
Niacin has been used to control cholesterol for decades, and an extended-release version called Niaspan, made by Abbott Laboratories, has been on sale for years.
In a 24-week study of about 1,600 patients, reported at a European cardiology conference in the fall, researchers found that compared with dummy pills, Cordaptive produced an 18 percent decline in levels of LDL cholesterol, a 26 percent decline in another type of blood fat called triglycerides and a 20 percent increase in HDL levels.
Merck also said that the F.D.A. rejected Cordaptive as a brand name, so it may use the name Tredaptive in the United States. The company noted that an advisory committee on Thursday recommended that European Union countries approve the drug. source