that merck is a person eithout a doul and wants only money as much as isis wants to load its drones with essence of africans containing the ebola virus to sow fear if not death in dendely populated areas
merck is as honest as a nassau county politicisns
while the white boy rants about drig prices the us kills its own citizens by failing to use useful science and art see faustmanlab.org pubmed.org ristori + bcg uspto.gov inventor sesrch faustmsn
the us discovered the cause and trestment for causalgia see ratner ej the lancet p106 jan 14, 1978 but hdid not apply and support its use
the us is the land of good ideas and evil minds
evaluate merck as you would the devil
Prescription-Drug Shortages Help Push Up Prices of Similar Drugs
New England Journal of Medicine article shows rise in prices of drugs used in alternative treatments
A vial of BCG, a drug for bladder cancer that has been in short supply because of manufacturing problems. PHOTO: MIKE BRADLEY
Prescription-drug supply shortages have hurt U.S. medical care in recent years. According to new research, they have also caused another side effect—drug-price increases.
A shortage of the bladder-cancer drug BCG in 2014 and 2015 led to sharp price increases for a less effective alternative treatment, mitomycin, according to research published online Wednesday by the New England Journal of Medicine.
The average wholesale price of a vial of mitomycin, a generic drug, nearly doubled to $869.59 in August 2014, shortly after the BCG shortage developed. The cost of a lower-dose vial of mitomycin rose 146% to $165.60.
The manufacturer of generic mitomycin, Accord Healthcare Inc., didn’t respond to emails and a phone call seeking comment.
As the BCG shortage continued due to manufacturing snafus at drugmakers Sanofi SA SNY 0.92% and Merck MRK 0.93% & Co., prices for mitomycin increased again in 2015, to $1,415 for the higher-dose vial and $272.46 for the lower dose, according to the research, which cites data from Truven Health Analytics. The increases contributed to higher spending on mitomycin by the federal Medicare health-insurance program for the elderly, rising to $15.8 million in 2015 from $4.3 million in 2012, according to the NEJM research.
“There’s a secondary shock” of shortages, said one of the NEJM article’s co-authors, Benjamin Davies, a urology professor at University of Pittsburgh School of Medicine, in an interview. “Not only can we not give you the drug we want to give you, but the drug we don’t want to give you is now more expensive than it was last month.”
Dr. Davies, who co-wrote the NEJM article with researchers from Harvard Medical School, said he and other urologists had “noticed immediately” the price of mitomycin jumped after the BCG shortage developed. “We assumed it was price gouging,” he said.
High and rising drug prices have sparked criticism of the pharmaceutical industry in recent years. President Donald Trump has called prices excessive and vowed to take steps to bring them down.
Other drug-supply disruptions have led to price increases. In 2011, Teva Pharmaceutical Industries Ltd. ceased production of an anti-parasitic agent, mebendazole. The price of an alternative treatment, albendazole, soared to $119.58 in 2013 for a typical daily dose from $5.92 in 2010, according to a 2014 NEJM article. Amedra Pharmaceuticals hiked the price after buying the marketing rights to the drug from GlaxoSmithKline PLC. Amedra is now part of Impax Laboratories Inc. ; an Impax spokesman said the drug’s price was already established when Impax acquired it, and the company doesn’t disclose product pricing.
The authors of the new NEJM paper say more should be done to prevent drug shortages, which are often caused by outdated manufacturing facilities. They proposed additional U.S. regulatory incentives for companies to maintain high-quality production capacity, and easing limits on the importation of drugs made outside the U.S.
The number of drugs in shortage in the U.S. peaked in 2014 at around 320 and has since declined, but there are still about 176 active shortages, according to the University of Utah Drug Information Service. Many shortages developed because companies failed to build enough production capacity, haven’t maintained equipment, and failed to ward off contamination in aging plants.
Factory contamination caused shortages of BCG, which forced doctors to delay treatment, cut dosing or switch patients to alternative treatment. Merck is now the sole supplier of BCG for the U.S. after Sanofi said in November it would cease production of its version.
A federal law passed in 2012 gave the U.S. Food and Drug Administration more powers to prevent and resolve shortages, including requiring manufacturers to provide advance notice to the agency of potential shortages, and allowing the FDA to speed up approvals of manufacturing upgrades.
Write to Peter Loftus at peter.loftus@wsj.com
Ebola Vaccine Headed to Congo to Help Contain Outbreak
The outbreak erupted in early April in remote villages but health officials fear the virus could be spreading to more populous areas
Merck’s experimental Ebola vaccine is on its way to the latest outbreak of the virus in the Democratic Republic of Congo, where health workers at Bikoro Hospital donned protective equipment before caring for suspected Ebola patients on May 12. PHOTO: MARK NAFTALIN/AGENCE FRANCE-PRESSE/GETTY IMAGES
The first doses of an experimental Ebola vaccine from Merck MRK 0.93% & Co. are expected to arrive before the end of this week in the Democratic Republic of Congo to help contain a new outbreak of the virus that is suspected of killing at least 19 people in the Central African nation.
At least 39 people have been confirmed or are believed to have been infected with Ebola in the country, according to the health ministry. The outbreak appears to have erupted in early April in forested villages reachable only by helicopter or motorbikes near the town of Bokoro. Health officials fear the virus could be spreading to more populous areas.
The outbreak is in Equateur province near the Congo River, a major transport route for the country’s riverside capital of Kinshasa, and the neighboring Republic of Congo’s Brazzaville.
The World Health Organization, in its latest update Monday, said two probable cases had been identified in the Wangata region close to the port city Mbandaka, population 1.2 million.
Health officials are following up with at least 390 people who have been identified as contacts of Ebola patients. The virus is transmitted by contact with the blood or fluids of an infected person.
With the outbreak spreading, officials are eager to inoculate health-care workers, family members and others in contact with the individuals who are sick, to stop the spread of the virus in a strategy known as “ring vaccination.” But it will still take several days for the vaccine to be distributed, WHO and Congo officials say.
The shipment of about 4,000 vaccine doses will come from a stockpile that Merck previously supplied to the World Health Organization for storage in Geneva, Switzerland, to be used for a “rapid response to any outbreak,” Merck spokeswoman Pamela Eisele said. Merck plans to send an additional 4,300 doses to WHO to support the response, she said.
That means distribution to the affected areas could happen early next week, said Jessica Ilunga, communications officer for Congo’s public-health ministry.
Merck has maintained a 300,000-dose stockpile in the U.S. and Europe since 2016 under an agreement struck with GAVI, the international vaccine alliance. GAVI supplied $1 million to cover costs of the vaccine rollout, Chief Executive Seth Berkley said.
Merck’s and other experimental Ebola vaccines haven’t received official marketing approval from U.S. or other government regulators, despite the acceleration in vaccine research and development after the 2014-2015 outbreak in West Africa that killed more than 11,000 people.
As a result, countries can’t order experimental vaccines and keep them on hand. Use of the Merck vaccine requires special approval, which can take time.
Once regulators approve a vaccine for marketing, it can be shipped quickly—usually within 48 hours—to an outbreak, said Dr. Berkley of GAVI.Then it can be used pre-emptively, to inoculate health-care workers and others who are likely to come in contact with Ebola patients, said Michael Osterholm, director of the Center for Infectious Disease Policy and Research at the University of Minnesota. Currently, use of the experimental vaccine is generally limited to people who come into contact with infected individuals, he said.
With an approved vaccine, “we could have an Ebola-prepared Africa, where the vaccine is really promoted among health-care workers, emergency responders and burial workers and we could pre-deploy it,” he said.
Merck, based in Kenilworth, N.J., licensed the rights to further develop and market an experimental vaccine in 2014 from NewLink Genetics Corp. , of Ames, Iowa, which had previously licensed it from the Public Health Agency of Canada. The vaccine, code-named V920, was effective in preventing Ebola virus disease among people who had come into contact with infected people in Guinea in 2015 and 2016, according to a study published in The Lancet.
Both U.S. and European regulators have designated the vaccine a high priority.
Under Merck’s original timetable, the company planned to apply to U.S. government regulators for marketing approval of the vaccine by the end of 2017. That would have set up the possibility of getting U.S. Food and Drug Administration or European Union marketing approval sometime this year.
Merck hasn’t filed because it has encountered “unforeseen facility and engineering issues” at a manufacturing plant it’s building in Burgwedel, Germany, where it plans to make the vaccine, Ms. Eisele said. It also is awaiting results from other clinical studies. Merck plans to file for regulatory approvals in 2019, she said.
GlaxoSmithKline PLC, the U.S. National Institutes of Health, and Johnson & Johnson are among other entities developing other Ebola vaccines. A J&J spokeswoman said the company is maintaining a stockpile of two million dosing regimens of its experimental Ebola vaccine, and is ready to provide them whenever needed. A spokesman for GSK, which co-developed a vaccine with the NIH, said it has stockpiled doses and is closely monitoring the situation.
The Congo government issued import permits for doses of the Merck vaccine last week, shortly after confirmation of the outbreak. The country has set up storage facilities to keep the vaccine doses at the required temperatures of as low as minus-80 degrees Celsius.
Congo has experience in dealing with Ebola outbreaks. The country has had nine in the past four decades, most recently in May 2017 in a remote location in the Bas-Uele province near the Ebola River, after which the virus was named in 1976. The government didn’t use the experimental vaccine in the 2017 outbreak partly because it hadn’t yet reviewed a study protocol necessary for its use and the outbreak fizzled out quickly.
This time, the government is better prepared, Ms. Ilunga said. “After last year’s outbreak, government has been putting in place more preventive measures,” she said.
Write to Peter Loftus at peter.loftus@wsj.com, Nicholas Bariyo at nicholas.bariyo@wsj.com and Betsy McKay at betsy.mckay@wsj.com
