The Menéndez Method

The Menéndez Method https://www.eresviral.com/wp-content/uploads/2018/10/El-Método-Menéndez-219x146.5

The Menéndez Method


After narrowly dodging a conviction for corruption, New Jersey Sen. Bob Menéndez faces a re-election bout against former

CEO Bob Hugin. The senator is now lying to voters about his opponent's business record in the way he disguised his political corruption.

Democrats always treat a republican candidate for business as if trade were criminal by definition, and Mr. Hugin is no exception. The Republican Senate candidate joined the New Jersey-based biotechnology firm Celgene in 1999 as a child and rose to CEO in 2010. He helped Celgene become one of the largest pharmaceutical companies in the country.


The big pharmaceutical industry is a perennial goal for politicians, and Mr. Menéndez has been vilifying Mr. Hugin for normal business practices. Among other things, his ads indicate that Mr. Hugin settled a $ 280 million lawsuit "for hiding information about potentially fatal side effects" and "raised the cost of a cancer drug three times in a year." These distortions must be corrected since the truth is that tens of thousands of patients have benefited from the innovations of Celgene.


The biggest blockbusters of Celgene have been Thalomid and Revlimid, which treat the rare multiple myeloma of blood cancer and are based on the compound thalidomide. While it was discovered that thalidomide caused birth defects in the 1950s, research in the 1990s suggested that it could treat diseases such as AIDS.


In 1998, the FDA approved Celgene's thalidomide application to treat leprosy, which affects approximately 100 Americans each year. The following year, the New England Journal of Medicine published a study that found that thalidomide "had substantial antitumor activity in patients with advanced myeloma," which is incurable with conventional chemotherapy.


Celgene began highlighting the potential of thalidomide to treat multiple myeloma before the FDA approved Thalomid and Revlimid in 2006. A former employee in 2010 sued Celgene for $ 40 billion under the False Claims Act for allegedly participating in off-label illegal promotions, paying bribes to doctors and billing Medicare for therapies.


Companies under FDA rules should not promote drugs for uses that have not been approved by the FDA, but some courts have ruled that this restriction violates the First Amendment. Physicians are allowed to prescribe medications for unapproved indications, and Medicare will reimburse non-cancer uses that are supported by clinical research.


Many doctors prescribed Celgene's drugs for multiple myeloma because they were superior to existing therapies and caused fewer serious side effects. The Department of Justice of Barack Obama decided not to intervene in the "qui tam" lawsuit, and a federal judge dismissed the allegations of bribes. Celgene settled the remaining claims last year for $ 280 million. Mr. Hugin's job was to maximize shareholder value, and resolving doubtful judgments is often a cost of doing business.


As for the accusation that Mr. Hugin attacked patients, the unfortunate reality is that curing cancer is not cheap. Between 2010 and 2017, the list price for a monthly dose of Revlimid doubled to around $ 18,000. Most patients pay much less out of pocket.


Generic manufacturers have complained that Celgene has used the FDA's Risk Assessment and Mitigation Strategy (REMS) program as a pretext to retain Revlimid samples that could be used to develop and test alternatives. This common industry strategy can extend the life of a patent for years. But Revlimid's patents do not expire until 2027, and earlier this year they agreed to allow


Natco Pharma


to introduce a generic competitor in 2022.


With the competition for CAR T cell treatments on the horizon, Celgene may now be trying to maximize the benefits of Revlimid that are necessary to fund research and development of other treatments. Celgene has trials for more than 40 new medications or indications in the pipeline. Earlier this year, Celgene bought the biotechnology company Juno, which has been a pioneer in CAR T cells.


***


None of Celgene's business practices is corrupt, unlike Menéndez's machinations to obtain visas for the brides of his doctor, friend Salomon Melgen. The senator also intervened for the doctor with the Department of Health and Human Services in a Medicare billing dispute involving reused vials of a macular degeneration drug that put patients at risk of infection.


Mr. Menéndez escaped his sentence thanks to the decision of the Supreme Court. McDonnell ruling that made it more difficult for prosecutors to prove corruption quid-pro-quo. But the Senate Ethics Committee "admonished" him severely, and New Jersey voters now have the opportunity to expel a man who abused his power to help a campaign donor in favor of a businessman who helped save lives .


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