The biotech industry raised a record $55.8 billion in 2009 despite hesitant stock and venture capital markets, as drug-company partnerships fed the cash-burning startups that develop new therapies.
That represents a jump of 85 percent over the $30.1 billion recorded in 2008, according to Steve Burrill, whose San Francisco firm Burrill & Co. is both an industry investor and analyst.
He said the 2009 results were driven by $37 billion in financial partnerships through which large drug companies license technologies or experimental remedies from biotech startups, a dynamic that enabled many small firms to survive a tough year. But it may ultimately limit their growth if they were forced to cede control over their most promising developments.
"You're not going to grow a lot more Genentechs or Amgens," Burrill said, painting a picture of a biotech industry that is increasingly the farm team that develops remedies that will ultimately be licensed and sold by the major league drug companies, also known as "Big Pharma."
That's the snapshot of the industry that emerges as 6,500 scientists, executives and financiers converge on San Francisco this week for the JP Morgan Healthcare Conference.
READ MORE @ S.F. CHRONICLE
Showing posts with label drug companies. Show all posts
Showing posts with label drug companies. Show all posts
Monday, January 11, 2010
Friday, January 8, 2010
Lawsuits filed over drug side effects
A Philadelphia law firm today said it filed 10 lawsuits on behalf of boys and young men who developed serious side effects - including the growth of breasts - while taking the antipsychotic medications Risperdal and Invega.
The suits were filed in Philadelphia Court of Common Pleas. Lawyer Stephen Sheller said he expected to file an additional 20 to 30 similar cases in Philadelphia in the next two months. His firm also has 10 cases involving boys who took Risperdal and another medication pending in New Jersey.
The drugs in the Philadelphia cases are made by Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals Inc., which is part of Johnson & Johnson. All of the companies, which are named in the suits, are based in New Jersey, but Ortho-McNeil-Janssen is incorporated in Pennsylvania, Sheller said.
Only one of the plaintiffs, a young man who took Risperdal in his teens, is from Philadelphia. He could not be reached for comment. The suit says he experienced rapid weight gain and developed breasts that will require surgical removal. The side effects caused him to suffer "mental anguish" and "embarrassment," the suit said.
Sheller said some of his already-troubled clients grew significant bosoms, a fact their doctors may not have taken seriously enough because of the weight gain. "I would say 38D, some of them," Sheller said. "No boy wants to have a B cup, certainly not a D."
Janssen declined to comment. "We have not received details of the cases and are therefore unable to comment at this time," spokeswoman Kara Russell said.
The suits also named Excerpta Medica Inc., of Bridgewater, N.J., and its parent, Elsevier Science Publishing Co. Inc., of New York. Sheller said the companies were involved in publishing ghostwritten studies they should have known were misleading or exaggerated. An Elsevier spokesman said the company had not had time to evaluate the suits.
READ MORE @ PHILADELPHIA INQUIRER
The suits were filed in Philadelphia Court of Common Pleas. Lawyer Stephen Sheller said he expected to file an additional 20 to 30 similar cases in Philadelphia in the next two months. His firm also has 10 cases involving boys who took Risperdal and another medication pending in New Jersey.
The drugs in the Philadelphia cases are made by Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals Inc., which is part of Johnson & Johnson. All of the companies, which are named in the suits, are based in New Jersey, but Ortho-McNeil-Janssen is incorporated in Pennsylvania, Sheller said.
Only one of the plaintiffs, a young man who took Risperdal in his teens, is from Philadelphia. He could not be reached for comment. The suit says he experienced rapid weight gain and developed breasts that will require surgical removal. The side effects caused him to suffer "mental anguish" and "embarrassment," the suit said.
Sheller said some of his already-troubled clients grew significant bosoms, a fact their doctors may not have taken seriously enough because of the weight gain. "I would say 38D, some of them," Sheller said. "No boy wants to have a B cup, certainly not a D."
Janssen declined to comment. "We have not received details of the cases and are therefore unable to comment at this time," spokeswoman Kara Russell said.
The suits also named Excerpta Medica Inc., of Bridgewater, N.J., and its parent, Elsevier Science Publishing Co. Inc., of New York. Sheller said the companies were involved in publishing ghostwritten studies they should have known were misleading or exaggerated. An Elsevier spokesman said the company had not had time to evaluate the suits.
READ MORE @ PHILADELPHIA INQUIRER
Monday, November 30, 2009
Should Drug Companies Carry Out Their Own Clinical Trials?
Two experts question on bmj.com today whether the conflict of interest is unethical when drug companies perform clinical trials on their own medicines.
Their opinions come as new guidance on the obligatory standards for communicating company sponsored medical research.
Vincent Lawton is a healthcare consultant and non-executive director at the Medicines and Healthcare products Regulatory Agency in London. He argues that after having invested billions of pounds in medicine development, it is unrealistic to expect the drug industry to "surrender its intellectual property." He comments that withdrawing research from pharmaceutical companies will lead to delays, ineffectiveness and a deficiency in innovation.
MEDICAL NEWS TODAY
Their opinions come as new guidance on the obligatory standards for communicating company sponsored medical research.
Vincent Lawton is a healthcare consultant and non-executive director at the Medicines and Healthcare products Regulatory Agency in London. He argues that after having invested billions of pounds in medicine development, it is unrealistic to expect the drug industry to "surrender its intellectual property." He comments that withdrawing research from pharmaceutical companies will lead to delays, ineffectiveness and a deficiency in innovation.
MEDICAL NEWS TODAY
Sunday, November 29, 2009
Patient advocates ill at ease with Rx data mining Patient advocates see sales tactic as medical meddling
When your doctor writes you a prescription, that's just between you, your doctor and maybe your health insurance company, right?
Wrong. The pharmaceutical companies that make those prescription drugs are also looking over the doctor's shoulder, keeping track of how many prescriptions for which drugs the physician is writing.
And that data on the prescribing habits of thousands of doctors has become a powerful sales and marketing tool for the pharmaceutical industry, but also a source of growing concern among some elected officials, health care advocates and legal authorities.
The identity of patients is not disclosed, but knowing in detail what doctors are prescribing enables drugmakers to fine-tune their messages when sales reps call on doctors. They can lobby for use of an alternative drug made by their own company, for instance, bolstering the pitch with specially selected research data or free samples.
What worries some government officials and patient advocates is that sales tactics keyed to a doctor's prescribing preferences may distort decision-making. That's especially likely, the critics say, when many doctors have trouble finding time to examine a plethora of studies and weigh the results carefully. And, given the concern over costs, they say, free samples or other inducements could influence decisions for nonmedical reasons.
The practice is known as "prescription data mining." Medical data firms annually blend several billion prescription records -- purchased from pharmacies and health insurers -- with physician data from the American Medical Association and other sources and sell the results to drug companies.
READ MORE @ CHICAGO TRIBUNE
Wrong. The pharmaceutical companies that make those prescription drugs are also looking over the doctor's shoulder, keeping track of how many prescriptions for which drugs the physician is writing.
And that data on the prescribing habits of thousands of doctors has become a powerful sales and marketing tool for the pharmaceutical industry, but also a source of growing concern among some elected officials, health care advocates and legal authorities.
The identity of patients is not disclosed, but knowing in detail what doctors are prescribing enables drugmakers to fine-tune their messages when sales reps call on doctors. They can lobby for use of an alternative drug made by their own company, for instance, bolstering the pitch with specially selected research data or free samples.
What worries some government officials and patient advocates is that sales tactics keyed to a doctor's prescribing preferences may distort decision-making. That's especially likely, the critics say, when many doctors have trouble finding time to examine a plethora of studies and weigh the results carefully. And, given the concern over costs, they say, free samples or other inducements could influence decisions for nonmedical reasons.
The practice is known as "prescription data mining." Medical data firms annually blend several billion prescription records -- purchased from pharmacies and health insurers -- with physician data from the American Medical Association and other sources and sell the results to drug companies.
READ MORE @ CHICAGO TRIBUNE
Friday, November 20, 2009
Rising Prices of Drugs Lead to Call for Inquiry
Democrats in Congress asked for two separate investigations of drug industry pricing Wednesday as they continue working on legislation to overhaul the nation’s health care system.
Responding to news reports of unusually high wholesale price increases in brand-name prescription drugs, four House leaders and one senator asked for government reviews of the pricing practices.
Although drug makers challenge the theory, some experts say the run-up in wholesale prices may be partly related to the industry’s concerns about future cost containment under any health care legislation.
“Recent studies have indicated that the industry may be artificially raising prices for certain pharmaceutical products in expectation of new reforms,” the House Democrats wrote in a letter to the Government Accountability Office, a nonpartisan investigative arm of Congress. “Any price gouging is unacceptable, but anticipatory price gouging is especially offensive,” the letter added, asking the G.A.O. to conduct an expedited review of the price increases.
READ MORE @ NY TIMES
Responding to news reports of unusually high wholesale price increases in brand-name prescription drugs, four House leaders and one senator asked for government reviews of the pricing practices.
Although drug makers challenge the theory, some experts say the run-up in wholesale prices may be partly related to the industry’s concerns about future cost containment under any health care legislation.
“Recent studies have indicated that the industry may be artificially raising prices for certain pharmaceutical products in expectation of new reforms,” the House Democrats wrote in a letter to the Government Accountability Office, a nonpartisan investigative arm of Congress. “Any price gouging is unacceptable, but anticipatory price gouging is especially offensive,” the letter added, asking the G.A.O. to conduct an expedited review of the price increases.
READ MORE @ NY TIMES
Tuesday, November 17, 2009
Medical Schools Quizzed on Ghostwriting
Senator Charles E. Grassley wrote to 10 top medical schools Tuesday to ask what they are doing about professors who put their names on ghostwritten articles in medical journals — and why that practice was any different from plagiarism by students.
Mr. Grassley, of Iowa, the ranking Republican on the Senate Finance Committee, sent the letters as part of his continuing investigation of so-called medical ghostwriting. The term refers to publication of medical journal articles in which an outside writer — sometimes paid by a drug or medical devices company whose product is being studied — has done extensive work on the article without being named on the publication. Instead, one or more academic researchers may receive author credit.
Mr. Grassley said ghostwriting had hurt patients and raised costs for taxpayers because it used prestigious academic names to promote medical products and treatments that might be expensive or less effective than viable alternatives.
Va href="http://www.nytimes.com/2009/11/18/business/18ghost.html?_r=1&ref=health">READ MORE @ NY TIMES
Mr. Grassley, of Iowa, the ranking Republican on the Senate Finance Committee, sent the letters as part of his continuing investigation of so-called medical ghostwriting. The term refers to publication of medical journal articles in which an outside writer — sometimes paid by a drug or medical devices company whose product is being studied — has done extensive work on the article without being named on the publication. Instead, one or more academic researchers may receive author credit.
Mr. Grassley said ghostwriting had hurt patients and raised costs for taxpayers because it used prestigious academic names to promote medical products and treatments that might be expensive or less effective than viable alternatives.
Va href="http://www.nytimes.com/2009/11/18/business/18ghost.html?_r=1&ref=health">READ MORE @ NY TIMES
Saturday, October 17, 2009
Should Michigan repeal immunity law for drug industry? Even after a felony plea, residents can't sue
Recently we learned that the Department of Justice will fine Pfizer $2.3 billion in civil and criminal penalties for its illegal marketing of the drugs Bextra, Zyvox, Geodon and Lyrica. This is not only the largest penalty ever levied against a drug company. It is the largest penalty ever levied against any company in American history.
That is saying something.
Pfizer and its subsidiary entities -- the former Upjohn and Pharmacia -- not only promoted these drugs for uses that were not approved by the FDA. They also marketed the drugs for uses that were explicitly rejected by the FDA, primarily because of safety concerns. To the degree that patients were killed or injured as a result, Pfizer's off-label marketing scheme amounts to negligent homicide.
That is probably why Pfizer was compelled to plead guilty to felony charges, which is also unprecedented in such contexts. In most instances, companies plea-bargain to misdemeanor admissions, fines are levied, and that is the end of it.
READ MORE @ DETROT FREE PRESS
That is saying something.
Pfizer and its subsidiary entities -- the former Upjohn and Pharmacia -- not only promoted these drugs for uses that were not approved by the FDA. They also marketed the drugs for uses that were explicitly rejected by the FDA, primarily because of safety concerns. To the degree that patients were killed or injured as a result, Pfizer's off-label marketing scheme amounts to negligent homicide.
That is probably why Pfizer was compelled to plead guilty to felony charges, which is also unprecedented in such contexts. In most instances, companies plea-bargain to misdemeanor admissions, fines are levied, and that is the end of it.
READ MORE @ DETROT FREE PRESS
Saturday, September 12, 2009
Ghost authors remain a chronic problem
Journal articles often list a long string of putative authors. I once counted 47 on a physics paper. But where journal articles in the natural sciences often appear overly conscientious about acknowledging all contributors, the opposite has become a nagging problem in biomedicine. Here, not all authors on a research project – or even, necessarily, the most important ones – may be identified as a contributor.
The existence of these ghost authors, as they’re called, evoked frustration and anger yesterday in a large share of the 400 journal editors and clinical research scientists taking part in a quadrennial international workshop on peer review and biomedical publication. This year’s venue: Vancouver, British Columbia.
The concern, speakers complained, is that ghost writers can be little more than hired guns. The expectation is that they will describe research findings in ways that aid their benefactors – drug or biomedical device companies that wish to avoid the appearance of directly influencing a clinical trial’s interpretation.
Often aiding and abetting the situation is another group of poseurs known as honorary authors. Their names show up on papers – despite their having done nothing – to lend credibility to research, to reward a friend of someone connected with the study, or to help hide the contributions of a ghost.
READ MORE @ SCIENCE NEWS
The existence of these ghost authors, as they’re called, evoked frustration and anger yesterday in a large share of the 400 journal editors and clinical research scientists taking part in a quadrennial international workshop on peer review and biomedical publication. This year’s venue: Vancouver, British Columbia.
The concern, speakers complained, is that ghost writers can be little more than hired guns. The expectation is that they will describe research findings in ways that aid their benefactors – drug or biomedical device companies that wish to avoid the appearance of directly influencing a clinical trial’s interpretation.
Often aiding and abetting the situation is another group of poseurs known as honorary authors. Their names show up on papers – despite their having done nothing – to lend credibility to research, to reward a friend of someone connected with the study, or to help hide the contributions of a ghost.
READ MORE @ SCIENCE NEWS
Friday, September 4, 2009
More drug firms doing follow-ups than thought--FDA
More pharmaceutical companies have completed studies required by U.S. health regulators after their products were allowed on the market than previously thought, according to an analysis released on Thursday.
But the study found that FDA database errors had obscured the issue, and critics said the post-approval studies, even when completed, still did not necessarily provide useful long-term information about the safety and effectiveness of the drugs.
Often, the Food and Drug Administration approves drugs and devices for sale on condition that companies keep studying the products for possible additional side effects or other issues.
For years, critics lamented such approvals because the FDA could only request more studies, but could not order them. The critics say companies had little incentive to do the studies once they won approval.
A 2007 law gave the agency more power to require the follow-up studies and ordered the analysis, which found more drug companies than previously thought had completed their studies. Results of the audit by Booz Allen Hamilton Inc were given to the FDA.
"Most companies are doing these studies and they are submitting the reports," said Dr. John Jenkins, director of the FDA's Office of New Drugs.
READ MORE @ REUTERS
But the study found that FDA database errors had obscured the issue, and critics said the post-approval studies, even when completed, still did not necessarily provide useful long-term information about the safety and effectiveness of the drugs.
Often, the Food and Drug Administration approves drugs and devices for sale on condition that companies keep studying the products for possible additional side effects or other issues.
For years, critics lamented such approvals because the FDA could only request more studies, but could not order them. The critics say companies had little incentive to do the studies once they won approval.
A 2007 law gave the agency more power to require the follow-up studies and ordered the analysis, which found more drug companies than previously thought had completed their studies. Results of the audit by Booz Allen Hamilton Inc were given to the FDA.
"Most companies are doing these studies and they are submitting the reports," said Dr. John Jenkins, director of the FDA's Office of New Drugs.
READ MORE @ REUTERS
Monday, August 31, 2009
Generic versions of biologic medications are coming Companies most likely to produce biogenerics
The days of market exclusivity could soon come to an end for the biotech industry if Congress moves forward with plans to finally allow generic biologics on the U.S. market.
Because of their eye-popping price tags, pressure to rein in the cost of biologics has been mounting on Capitol Hill for some time. A process for approving generic versions of traditional chemical medications has been in place for more than a decade, but Congress has yet to establish a similar legal pathway for biologics.
But all that could change in the next few months. Currently, almost all of the leading healthcare reform bills circulating on the Hill call for allowing the Food and Drug Administration to establish an approval process for generic biologics, also known as biogenerics or biosimilars.
Unlike traditional drugs, which are comprised of chemicals, biologics use living cells to treat diseases and disorders. The drug category includes some of the most popular therapies on the market: Cancer treatments such as Roche's /quotes/comstock/11i!rhhby (RHHB.Y 39.12, -0.72, -1.81%) Avastin and Herceptin; rheumatoid arthritis drugs such as Amgen Inc.'s /quotes/comstock/15*!amgn/quotes/nls/amgn (AMGN 58.98, -0.80, -1.34%) and Wyeth's /quotes/comstock/13*!wye/quotes/nls/wye (WYE 47.79, -0.06, -0.13%) Enbrel, Johnson & Johnson's /quotes/comstock/13*!jnj/quotes/nls/jnj (JNJ 59.94, -0.50, -0.83%) and Schering-Plough Corp.'s /quotes/comstock/13*!sgp/quotes/nls/sgp (SGP 27.79, -0.39, -1.38%) Remicade, and Abbott Laboratories' /quotes/comstock/13*!abt/quotes/nls/abt (ABT 45.12, -0.11, -0.24%) Humira; and multiple sclerosis therapies such as Biogen Idec's /quotes/comstock/15*!biib/quotes/nls/biib (BIIB 49.24, -0.96, -1.91%) Avonex.
READ MORE @ MARKET WATCH
Because of their eye-popping price tags, pressure to rein in the cost of biologics has been mounting on Capitol Hill for some time. A process for approving generic versions of traditional chemical medications has been in place for more than a decade, but Congress has yet to establish a similar legal pathway for biologics.
But all that could change in the next few months. Currently, almost all of the leading healthcare reform bills circulating on the Hill call for allowing the Food and Drug Administration to establish an approval process for generic biologics, also known as biogenerics or biosimilars.
Unlike traditional drugs, which are comprised of chemicals, biologics use living cells to treat diseases and disorders. The drug category includes some of the most popular therapies on the market: Cancer treatments such as Roche's /quotes/comstock/11i!rhhby (RHHB.Y 39.12, -0.72, -1.81%) Avastin and Herceptin; rheumatoid arthritis drugs such as Amgen Inc.'s /quotes/comstock/15*!amgn/quotes/nls/amgn (AMGN 58.98, -0.80, -1.34%) and Wyeth's /quotes/comstock/13*!wye/quotes/nls/wye (WYE 47.79, -0.06, -0.13%) Enbrel, Johnson & Johnson's /quotes/comstock/13*!jnj/quotes/nls/jnj (JNJ 59.94, -0.50, -0.83%) and Schering-Plough Corp.'s /quotes/comstock/13*!sgp/quotes/nls/sgp (SGP 27.79, -0.39, -1.38%) Remicade, and Abbott Laboratories' /quotes/comstock/13*!abt/quotes/nls/abt (ABT 45.12, -0.11, -0.24%) Humira; and multiple sclerosis therapies such as Biogen Idec's /quotes/comstock/15*!biib/quotes/nls/biib (BIIB 49.24, -0.96, -1.91%) Avonex.
READ MORE @ MARKET WATCH
Thursday, August 20, 2009
Senator Moves to Block Medical Ghostwriting
A growing body of evidence suggests that doctors at some of the nation’s top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters working for drug companies — articles that were carefully calibrated to help the manufacturers sell more products.
Experts in medical ethics condemn this practice as a breach of the public trust. Yet many universities have been slow to recognize the extent of the problem, to adopt new ethical rules or to hold faculty members to account.
Those universities may not have much longer to get their houses in order before they find themselves in trouble with Washington.
With a letter last week, a senator who helps oversee public funding for medical research signaled that he was running out of patience with the practice of ghostwriting. Senator Charles E. Grassley, an Iowa Republican who has led a long-running investigation of conflicts of interest in medicine, is starting to put pressure on the National Institutes of Health to crack down on the practice.
READ MORE @ NY TIMES
Experts in medical ethics condemn this practice as a breach of the public trust. Yet many universities have been slow to recognize the extent of the problem, to adopt new ethical rules or to hold faculty members to account.
Those universities may not have much longer to get their houses in order before they find themselves in trouble with Washington.
With a letter last week, a senator who helps oversee public funding for medical research signaled that he was running out of patience with the practice of ghostwriting. Senator Charles E. Grassley, an Iowa Republican who has led a long-running investigation of conflicts of interest in medicine, is starting to put pressure on the National Institutes of Health to crack down on the practice.
READ MORE @ NY TIMES
Wednesday, July 22, 2009
Can the relationship between doctors and drug companies ever be a healthy one?
Should the financial ties between doctors and drug companies be completely cut, or are healthy alliances between the two possible with the common aim of improving human health? A debate in this week's PLoS Medicine discusses whether the influence of drug company money on doctors is always a corrupting one.
READ MORE @ EUREKALERT
READ MORE @ EUREKALERT
Saturday, July 11, 2009
ANALYSIS-Drug companies fight the tide, and may win
Governments on both sides of the Atlantic are fighting settlements between big pharmaceutical companies and generic firms that delay marketing of cheap versions of brand-name drugs.
But don't write off the chances of Big Pharma, which has already shown impressive clout in both the legal and political arenas.
The settlements are reached after generic companies indicate they plan to bring out cheaper copies of brand-name drugs, and the drugs' makers accuse the generics of infringement.
The U.S. Federal Trade Commission says the settlements are illegal if generic entrances are delayed in exchange for payment, but drug companies say the deals are no more than settlements of what could be expensive litigation.
EU Competition Commissioner Neelie Kroes said this week that she was determined to oppose such settlements, which she said had pushed up European consumers' bills by 20 percent between 2000 and 2007. The FTC puts the cost for U.S. consumers and insurers at an additional $3.5 billion a year.
Drug companies say the settlements can save consumers money by bringing generics to market before patents expire, while eliminating the uncertainties of court trials.
READ MORE @ FORBES
But don't write off the chances of Big Pharma, which has already shown impressive clout in both the legal and political arenas.
The settlements are reached after generic companies indicate they plan to bring out cheaper copies of brand-name drugs, and the drugs' makers accuse the generics of infringement.
The U.S. Federal Trade Commission says the settlements are illegal if generic entrances are delayed in exchange for payment, but drug companies say the deals are no more than settlements of what could be expensive litigation.
EU Competition Commissioner Neelie Kroes said this week that she was determined to oppose such settlements, which she said had pushed up European consumers' bills by 20 percent between 2000 and 2007. The FTC puts the cost for U.S. consumers and insurers at an additional $3.5 billion a year.
Drug companies say the settlements can save consumers money by bringing generics to market before patents expire, while eliminating the uncertainties of court trials.
READ MORE @ FORBES
Friday, March 27, 2009
3 Researchers at Harvard Are Named in Subpoena
Federal prosecutors have issued a subpoena seeking information about the work and statements of three prominent Harvard researchers who have been the focus of a Congressional investigation into conflicts of interest in medicine.
The researchers — Drs. Joseph Biederman, Thomas Spencer and Timothy E. Wilens — are named in the subpoena, which was sent on Wednesday to Fletch Trammel, a lawyer who represents state attorneys general in lawsuits that claim makers of antipsychotic drugs defrauded state Medicaid programs by improperly marketing their medicines.
READ MORE @ NY TIMES
The researchers — Drs. Joseph Biederman, Thomas Spencer and Timothy E. Wilens — are named in the subpoena, which was sent on Wednesday to Fletch Trammel, a lawyer who represents state attorneys general in lawsuits that claim makers of antipsychotic drugs defrauded state Medicaid programs by improperly marketing their medicines.
READ MORE @ NY TIMES
Friday, March 6, 2009
Crackdown on Doctors Who Take Kickbacks
Federal health officials and prosecutors, frustrated that they have been unable to stop illegal kickbacks to doctors from drug and device companies, are investigating doctors who take money for using these products.
For years, prosecutors rarely pursued doctors because they believed that juries would sympathize with respected clinicians. But within a few months, officials plan to file civil and criminal charges against a number of surgeons who they say demanded profitable consulting agreements from device makers in exchange for using their products.
“What we need to do is make examples of a couple of doctors so that their colleagues see that this isn’t worth it,” said Lewis Morris, chief counsel to the inspector general of the Department of Health and Human Services. “We want to send the message to the physician community — particularly surgeons — that you can’t do this.”
The move against doctors is part of a diverse campaign to curb industry marketing tactics that enrich doctors but increase health care costs and sometimes endanger patients. Taken together, the new measures are likely to transform the relationship between medicine and industry.
READ MORE @ NY TIMES
For years, prosecutors rarely pursued doctors because they believed that juries would sympathize with respected clinicians. But within a few months, officials plan to file civil and criminal charges against a number of surgeons who they say demanded profitable consulting agreements from device makers in exchange for using their products.
“What we need to do is make examples of a couple of doctors so that their colleagues see that this isn’t worth it,” said Lewis Morris, chief counsel to the inspector general of the Department of Health and Human Services. “We want to send the message to the physician community — particularly surgeons — that you can’t do this.”
The move against doctors is part of a diverse campaign to curb industry marketing tactics that enrich doctors but increase health care costs and sometimes endanger patients. Taken together, the new measures are likely to transform the relationship between medicine and industry.
READ MORE @ NY TIMES
Sunday, February 15, 2009
Drug giant GlaxoSmithKline pledges cheap medicine for world's poor Head of GSK shocks industry with challenge to other 'big pharma' companies
The world's second biggest pharmaceutical company is to radically shift its attitude to providing cheap drugs to millions of people in the developing world.
In a major change of strategy, the new head of GlaxoSmithKline, Andrew Witty, has told the Guardian he will slash prices on all medicines in the poorest countries, give back profits to be spent on hospitals and clinics and – most ground-breaking of all – share knowledge about potential drugs that are currently protected by patents.
Witty says he believes drug companies have an obligation to help the poor get treatment. He challenges other pharmaceutical giants to follow his lead.
Pressure on the industry has been growing over the past decade, triggered by the Aids catastrophe.
Drug companies have been repeatedly criticised for failing to drop their prices for HIV drugs while millions died in Africa and Asia. Since then, campaigners have targeted them for defending the patents, which keep their prices high, while attempting to crush competition from generic manufacturers, who undercut them dramatically in countries where patents do not apply.
READ MORE @ THE GUARDIAN
In a major change of strategy, the new head of GlaxoSmithKline, Andrew Witty, has told the Guardian he will slash prices on all medicines in the poorest countries, give back profits to be spent on hospitals and clinics and – most ground-breaking of all – share knowledge about potential drugs that are currently protected by patents.
Witty says he believes drug companies have an obligation to help the poor get treatment. He challenges other pharmaceutical giants to follow his lead.
Pressure on the industry has been growing over the past decade, triggered by the Aids catastrophe.
Drug companies have been repeatedly criticised for failing to drop their prices for HIV drugs while millions died in Africa and Asia. Since then, campaigners have targeted them for defending the patents, which keep their prices high, while attempting to crush competition from generic manufacturers, who undercut them dramatically in countries where patents do not apply.
READ MORE @ THE GUARDIAN
Tuesday, February 10, 2009
Psychiatrists may cut some ties to drug firms
Dr. Daniel Carlat knows all too well how easy it is for doctors to be seduced by drug industry money.
In 2002, he earned $30,000 in speaking fees to promote Wyeth's antidepressant Effexor XR to fellow doctors.
"I quit doing it because I felt I was beginning to push some ethical boundaries in terms of what I was saying and what I was not saying," said Carlat, a psychiatry professor at Tufts University in Boston who believes doctors need to cut their financial ties with drug companies.
"My own story was really nothing special," he said in a telephone interview. "I made $30,000 for the year, which is less than some of these doctors make in a weekend."
Carlat and other psychiatrists have been studying the issue and have proposed that the American Psychiatric Association cut back on medical education seminars funded by drug companies.
READ MORE @ REUTERS
In 2002, he earned $30,000 in speaking fees to promote Wyeth's antidepressant Effexor XR to fellow doctors.
"I quit doing it because I felt I was beginning to push some ethical boundaries in terms of what I was saying and what I was not saying," said Carlat, a psychiatry professor at Tufts University in Boston who believes doctors need to cut their financial ties with drug companies.
"My own story was really nothing special," he said in a telephone interview. "I made $30,000 for the year, which is less than some of these doctors make in a weekend."
Carlat and other psychiatrists have been studying the issue and have proposed that the American Psychiatric Association cut back on medical education seminars funded by drug companies.
READ MORE @ REUTERS
Tuesday, January 27, 2009
Obama battles big pharma
Pfizer's latest mega deal reflects the threats faced by global drugs firms, not least from the new US president, says Alistair Dawber
"We will lower drug costs by allowing the importation of safe medicines from other developed countries, increasing the use of generic drugs in public programmes and taking on drug companies that block cheaper generic medicines from the market." The wording of President Obama's healthcare policy could not be clearer and should send a shiver through the boardroom of every major pharmaceutical group in the world.
For some time, the big players in the drugs market have faced a simple problem. Treatments that the likes of Pfizer, Novartis and GlaxoSmithKline (GSK) have spent years and millions of dollars developing are increasingly coming under threat from the generics companies, which invest nearly as much energy in challenging patents and developing cheaper alternatives. The established groups may consider the generics firms parasitical, but the likes of Barack Obama and the European Commission are tiring of the big beasts hiding behind patents ensuring that healthcare is more expensive to the ultimate user.
The European Commission said in November that the pharmaceutical groups are blocking the entry of new, cheaper drugs on to the market and that this cost EU healthcare providers, including the National Health Service, an estimated €3bn between 2000 and 2007. It added that it "will not hesitate to open antitrust cases against companies where there are indications that the antitrust rules may have been breached."
READ MORE @ INDEPENDENT
"We will lower drug costs by allowing the importation of safe medicines from other developed countries, increasing the use of generic drugs in public programmes and taking on drug companies that block cheaper generic medicines from the market." The wording of President Obama's healthcare policy could not be clearer and should send a shiver through the boardroom of every major pharmaceutical group in the world.
For some time, the big players in the drugs market have faced a simple problem. Treatments that the likes of Pfizer, Novartis and GlaxoSmithKline (GSK) have spent years and millions of dollars developing are increasingly coming under threat from the generics companies, which invest nearly as much energy in challenging patents and developing cheaper alternatives. The established groups may consider the generics firms parasitical, but the likes of Barack Obama and the European Commission are tiring of the big beasts hiding behind patents ensuring that healthcare is more expensive to the ultimate user.
The European Commission said in November that the pharmaceutical groups are blocking the entry of new, cheaper drugs on to the market and that this cost EU healthcare providers, including the National Health Service, an estimated €3bn between 2000 and 2007. It added that it "will not hesitate to open antitrust cases against companies where there are indications that the antitrust rules may have been breached."
READ MORE @ INDEPENDENT
Sunday, January 4, 2009
Drug companies seek a cure for their ailing research. With costs and regulation rising, a new way of developing blockbuster treatments is needed.
THERE was warm applause for Lord [James] Black last month when the veteran drug developer stepped up in front of an 800-strong audience of business leaders and VIPs in the City to collect an award. The Nobel prize winner was being honoured by Medical Futures, a healthcare interest group, for his contribution to medical research — he is responsible for developing beta blockers, among other significant breakthroughs.
However, Black wonders whether, if he had been in his professional prime in today’s environment, his various discoveries would have happened. He argues that a safety-first approach is hindering the development of the next generation of blockbuster drugs.
“The problem, in my recent experience of trawling new products round big pharma’s R&D divisions, is that they are only comfortable in well-recognised fields,” he said.
READ MORE @ TIMES ONLINE UK
However, Black wonders whether, if he had been in his professional prime in today’s environment, his various discoveries would have happened. He argues that a safety-first approach is hindering the development of the next generation of blockbuster drugs.
“The problem, in my recent experience of trawling new products round big pharma’s R&D divisions, is that they are only comfortable in well-recognised fields,” he said.
READ MORE @ TIMES ONLINE UK
Sunday, December 21, 2008
FDA Faults Drug Information for Consumers
The printed consumer information that accompanies new prescription drugs is often difficult to read or understand, the U.S. Food and Drug Administration said Tuesday.
In a new report, the FDA said the "consumer medication information" -- intended to spell out the proper use and risks of drugs -- failed to meet a Congressionally mandated goal that 95 percent of all new prescriptions be accompanied by useful guidance.
"The study reveals that consumers are not consistently getting the information they need to promote the safe and effective use of prescription medicines," Dr. Paul Seligman, associate director of safety policy and communication at the FDA's Center for Drug Evaluation and Research, said during a Tuesday teleconference.
READ MORE @ WASHINGTON POST
In a new report, the FDA said the "consumer medication information" -- intended to spell out the proper use and risks of drugs -- failed to meet a Congressionally mandated goal that 95 percent of all new prescriptions be accompanied by useful guidance.
"The study reveals that consumers are not consistently getting the information they need to promote the safe and effective use of prescription medicines," Dr. Paul Seligman, associate director of safety policy and communication at the FDA's Center for Drug Evaluation and Research, said during a Tuesday teleconference.
READ MORE @ WASHINGTON POST
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