http://prescriptions.blogs.nytimes.com/2010/01/14/biologic-drugs-may-get-less-protection/ May Get Less Protection

President Obama is pushing for a last-minute change in the final health care bill that would shorten the time that expensive biotechnology drugs would be shielded from generic competition, pharmaceutical industry officials said Thursday.

Any White House intervention would be welcome news to generic pharmaceutical companies, as well as to some consumer groups, insurers and big employers, which have complained that the proposed House and Senate bills would not allow for robust competition.

But it could throw another wrench into negotiations. At a time when Congressional leaders are trying to resolve differences in the House and Senate bills, the issue of biotech drugs is one aspect on which both bills agree.

Both the House and Senate bills would for the first time create rules by which so-called biologic drugs, which are made in living cells, would be subject to copycat competition, saving the health care system billions of dollars over 10 years.

The drugs, which include big sellers like the cancer drug Avastin and the arthritis drug Enbrel, can cost tens of thousands of dollars a year. Biologics are not governed by the Hatch-Waxman Act, which covers generic competition for more conventional drugs made from chemicals, like Prozac or Lipitor. After the patent on a biologic drug expires, competitors may produce similar products, but they are treated by the health care system as if they were entirely new drugs, not substitutes like generics.

READ MORE @ NY TIMES

Rx America: Drug companies want patent protection in health care overhaul

As Congress debates a health-care insurance overhaul, the pharmaceutical industry is lobbying heavily for expanded patent protections that its lobbyists say are necessary to protect the industry’s investments and encourage future developments.

The question is how long a period a drug developer will have exclusive rights to a certain kind of drug – called biologics – before competitors can be allowed into the market with generic versions.

Biologics are costly drugs produced from living organisms, not from chemicals as the more common small molecule drugs are composed. Americans spend an estimated $40 billion per year on the drugs, which comprise almost a third of Medicare Part B spending.

PhRMA – the lobbying arm of the industry headed by former Louisiana Congressman Billy Tauzin – wants at least 12 years of protection from competition, saying that’s about what it would take, on average, to recoup the initial research and development investment of getting a drug to the marketplace.

READ MORE @ NEW ORLEANS PICAYUNE

The Politics Behind Despair and Depression

On September 14, 2007, New York Times reporters Alex Berenson and Benedict Carey foiled, at least temporarily, Big Pharma and its psychiatry allies' attempt to eliminate the U.S. Food and Drug Administration warning label about increased suicidal thoughts and behaviors in minors using antidepressants.

Berenson and Carey refuted a September 2007 American Journal of Psychiatry article that had claimed an increase in the youth suicide rate in 2004 was related to declining antidepressant prescriptions for that group (caused by the FDA warning). Berenson and Carey reported that, in fact, in 2004 the "number of prescriptions for antidepressants in that group was basically unchanged and did not drop substantially." The New York Times did not, however, report that the lead author of the American Journal of Psychiatry article had served as an expert witness for Wyeth Pharmaceuticals, makers of the antidepressant Effexor.

While the recent smoke and mirrors of Big Pharma and the American Journal of Psychiatry was detected by The New York Times, the media, once again, is losing sight of a more important revelation: scientists currently agree that "the neurotransmitter-deficiency theory of depression"--the rationale for antidepressants--has no validity.

READ MORE @ HUFFINGTON POST

Drugs industry economics 'not sustainable' - report

The pharmaceutical industry business model is "economically unsustainable", according to a report by accountants PricewaterhouseCoopers. The study suggested drug companies' reliance on heavy marketing of a few drugs in the hope of huge sales meant they were "operationally incapable" of acting quickly enough to produce innovative treatments demanded by global markets.

According to Steve Arlington, the main author, drug companies spend twice as much on research and development than 10 years ago, yet produce half as many drugs: 40 to 45% of medicines in phase 3 clinical trials, the last stage, now failed.

READ MORE @ THE GUARDIAN